"Oncology"

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When breast cancer hits home

A perspective on courage and perseverance

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Taking on lung cancer is worth the fight

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Dealing with cancer, disparities and a pandemic all at once

Katie Couric and Merck’s Dr. Julie Gerberding shine a light on living with cancer during the pandemic and the challenges compounded by disparities across both diseases.

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A painter, cook and cancer-fighting champion - meet Wendy Short Bartie

She dreamed of becoming a mayor. Instead, she found a new passion and grew to lead a different kind of community

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I'm a cancer survivor. Now what?

Your Cancer Story is your go-to online hub for patients, caregivers and survivors dealing with cancer

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Cancer care during COVID-19: No patient left behind

By Dr. Roy Baynes, chief medical officer

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Living with cancer during a pandemic

Katie Couric brings us the real-life complexities of coping with cancer today

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My HPV Cancer Story

We're proud to introduce My HPV Cancer Story, a program to raise awareness around the link between HPV (human papillomavirus) and certain cancers and diseases in women and men.

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Inspiring people, one day at a time

“I am a survivor and HOPEologist, and I will dedicate my life to helping others.”

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5 ways to support a loved one living with lung cancer

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Merck joins the World Cancer Day movement to push for progress

Cancer is one of the most significant health challenges of our time – cutting lives too short for far too many people.

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Facing breast cancer three times – a profile of hope

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It takes a village

Collaborating to make a difference in the lives of people with bladder cancer

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Five truths about lung cancer

What everyone needs to know about one of the most common types of cancer

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Lung cancer

Lung cancer is the most commonly diagnosed cancer worldwide.

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'You never forget that day'

One man’s courageous story of living with advanced lung cancer

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How we are building a strong foundation in pancreatic cancer research

Dr. Peter Kang, executive director, clinical research, Merck Research Laboratories, shares his perspective on why there are reasons for hope.

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Driving melanoma research forward

An interview with Dr. Nageatte Ibrahim, associate vice president, oncology, global clinical development

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Understanding melanoma

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Understanding head and neck cancer

What is head and neck cancer? Head and neck cancer is a term used to describe a number of different malignant tumors that develop in or around the throat, larynx (voice box), nose, sinuses and mouth

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HPV and certain cancers: What you need to know

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Let's talk about kidney cancer

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Merck stands united on World Cancer Day

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HPV and cervical cancer: What you need to know

Get informed about cervical cancer. Learn more about the connection between cervical cancer and human papillomavirus, or HPV.

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Rallying to meet the need

We understand how important it is to get oncology medicines to the people who need them, and providing those medicines is at the center of what we do.

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Dr. Cathy Pietanza: ‘each day, I’m reminded of my patients’

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Progression-Free Survival (PFS) as First-Line Treatment for Metastatic Triple-Negative Breast Cancer (mTNBC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer (mTNBC) whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10). Based on an interim analysis conducted by an independent Data Monitoring Committee (DMC), first-line treatment with KEYTRUDA in combination with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine/carboplatin) demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone in these patients. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The safety profile of KEYTRUDA in this trial was consistent with that observed in

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FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in HRR-Mutated Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, who have progressed following prior treatment with a new hormonal agent. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. The sNDA acceptance for review by the FDA is based on positive results from the Phase 3 PROfound trial, which were presented during a Presidential Symposium at the 2019 European Society of Medical Oncology congress. Results of the PROfound trial showed LYNPARZA met its primary endpoint, significantly reducing the risk of radiographic disease progression or death by 66% in

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FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) as First-Line Maintenance with Bevacizumab in Advanced Ovarian Cancer and Grants Priority Review

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that a supplemental New Drug Application (sNDA) for LYNPARZA in combination with bevacizumab has been accepted and granted priority review by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of women with advanced ovarian cancer whose disease showed a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. The regulatory submission is based on the results from the pivotal Phase 3 PAOLA-1 trial, which were published in The New England Journal of Medicine . The trial compared LYNPARZA when added to standard-of-care (SoC) bevacizumab versus bevacizumab alone in women with advanced ovarian cancer in the first-line maintenance setting, regardless of their genetic biomarker status or outcome from previous surgery. The

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. “Today’s approval of KEYTRUDA reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.” Immune-mediated adverse reactions, which may be severe or fatal, can occur with

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Significantly Improved Progression-Free Survival Compared to Chemotherapy Alone as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-604 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis. At the final analysis of the study, there was also an improvement in overall survival (OS) for patients treated with KEYTRUDA in combination with chemotherapy compared to chemotherapy alone; however, these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.80 [95% CI, 0.64-0.98]). The safety profile

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Merck Establishes Strategic Oncology Collaboration with Taiho and Astex

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd., (“Taiho”) and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. (“Astex”), focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer. “At Merck we continue to pursue new regimens designed to extend the benefits of highly selective therapies to more patients with cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This agreement with Taiho and Astex combines our respective small molecule assets and industry-leading expertise in cancer cell signaling to enable development of the most promising drug candidates.” Under the terms of the agreement, Merck, Taiho and Astex will combine preclinical candidates and their

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LYNPARZA® (olaparib) Approved by FDA as First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. The approval follows the recommendation by the U.S. FDA Oncologic Drugs Advisory Committee on Dec. 17 for LYNPARZA in this indication and was based on results from the pivotal Phase 3 POLO trial published in the New England Journal of Medicine and presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting. Results showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) where LYNPARZA

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Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Three New First-Line Indications Across Advanced Renal Cell Carcinoma (RCC) and Recurrent or Distant Metastatic Head and Neck Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA) in advanced renal cell carcinoma (RCC) and head and neck cancer for the following additional indications in Japan: KEYTRUDA in combination with Inlyta (axitinib) for the first-line treatment of patients with radically unresectable or metastatic RCC; KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer; and KEYTRUDA monotherapy for the first-line treatment of patients with recurrent or distant metastatic head and neck cancer. “Advanced renal cell carcinoma and head and neck cancer have historically been associated with poor outcomes and new treatment options are needed in Japan,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “Today’s

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FDA Oncologic Drugs Advisory Committee (ODAC) Recommends KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 9-4 in favor of recommending KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC). The ODAC discussions were based on the supplemental Biologics License Application (sBLA), currently under priority review at the FDA, seeking approval of KEYTRUDA monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). This application is based on results from the Phase 2 KEYNOTE-057 trial. “The positive vote from today’s ODAC meeting supports the potential for KEYTRUDA in certain patients with high-risk, non-muscle invasive bladder cancer,

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LYNPARZA® (olaparib) Recommended by FDA Advisory Committee for First-Line Maintenance Therapy in Germline BRCA-Mutated Metastatic Pancreatic Cancer That Has Not Progressed on Platinum-Based Chemotherapy

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 7-5 to recommend LYNPARZA as a first-line maintenance monotherapy for patients with germline BRCA -mutated (g BRCA m) metastatic adenocarcinoma of the pancreas (pancreatic cancer), whose disease has not progressed on at least 16 weeks of first-line platinum-based chemotherapy. In August 2019, the FDA accepted the supplemental New Drug Application (sNDA) for LYNPARZA for this indication with Priority Review and set a Prescription Drug User Fee Act (PDUFA) date for the fourth quarter of 2019. Dr. José Baselga, executive vice president, oncology R&D, AstraZeneca, said, “We are pleased with the ODAC’s recommendation for LYNPARZA and the potential to bring a personalized, biomarker-targeted medicine to patients with germline BRCA -mutated metastatic pancreatic cancer. Patients with advanced

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Data from Exploratory Analysis Show Merck’s KEYTRUDA® (pembrolizumab) Improved Overall Survival as Monotherapy for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer Regardless of KRAS Mutational Status

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, showed improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) as monotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥1%), regardless of KRAS mutational status. These findings, which are based on an exploratory analysis of the pivotal Phase 3 KEYNOTE-042 trial, were presented today in a proffered paper presentation (Abstract #LBA4) at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2019 in Geneva, Switzerland. “KRAS mutations occur in approximately 20% of people with non-small cell lung cancer, and some previous studies have suggested that these mutations are associated with a poorer response to treatment,” said Dr. Jonathan Cheng, vice president, oncology clinical

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Merck to Acquire ArQule, Advancing Leadership in Oncology

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and ArQule, Inc. (Nasdaq: ARQL) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire ArQule for $20 per share in cash for an approximate total equity value of $2.7 billion. ArQule is a publicly traded biopharmaceutical company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. ArQule’s lead investigational candidate, ARQ 531, is a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies. “ArQule’s focus on precision medicine has yielded multiple clinical-stage oral kinase inhibitors that have novel and important properties,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This acquisition strengthens Merck’s pipeline with the addition of these strategic assets including,

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LYNPARZA® (olaparib) Approved in China as a First-Line Maintenance Therapy in BRCA-Mutated (BRCAm) Advanced Ovarian Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the companies have received marketing authorization from China’s National Medical Products Administration (NMPA) for LYNPARZA as a first-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA -mutated (g BRCA m or s BRCA m) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. The approval in China is based on the results from the pivotal Phase 3 SOLO-1 trial, which were published in the New England Journal of Medicine. Results showed that LYNPARZA significantly reduced the risk of disease progression or death by 70% versus placebo in women with BRCAm advanced ovarian cancer following response to platinum-based chemotherapy (HR 0.30 [95% CI, 0.23-0.41], p<0.001). At 36 months, the estimated progression-free survival (PFS) rate was 60% for

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Certain Patients with High-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy. The application seeks approval of KEYTRUDA monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy (removal of bladder). This application for KEYTRUDA, which is based on results from the Phase 2 KEYNOTE-057 trial, will be discussed at the Dec. 17 meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC). Data from this trial were first presented at the European Society for Medical Oncology 2018 Congress. Merck anticipates a Prescription Drug User Fee Act (PDUFA), or target action date, in

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European Commission Approves Two New Regimens of Merck’s KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (combined positive score [CPS] ≥1). This approval is based on findings from the pivotal Phase 3 KEYNOTE-048 trial, in which KEYTRUDA, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), demonstrated a significant improvement in overall survival (OS) as monotherapy (HR = 0.74 [95% CI, (0.61-0.90); p=0.00133] and in combination with chemotherapy (HR=0.65 [95% CI, 0.53-0.80]; p=0.00002), in patients whose tumors expressed PD-L1 (CPS ≥1). “This disease is especially debilitating since it can be highly visible and affect a patient’s appearance and their

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US FDA Accepts Regulatory Submission of New Drug Application for Selumetinib in Neurofibromatosis Type 1 (NF1) and Grants Priority Review

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs). This is the first acceptance of a regulatory submission for an oral MEK 1/2 monotherapy for patients with NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. This regulatory submission was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored SPRINT Phase 2 Stratum 1 trial. An objective response rate (ORR) was achieved in 66% of pediatric patients with NF1 and symptomatic, inoperable PNs (n=33/50 patients) when treated

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Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of two regimens of KEYTRUDA, Merck’s anti-PD-1 therapy, for the first-line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC). KEYTRUDA, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is recommended in patients whose tumors express PD-L1 (combined positive score [CPS] ≥1). This recommendation is based on data from the pivotal Phase 3 KEYNOTE-048 trial, in which KEYTRUDA, as monotherapy and in combination with chemotherapy, demonstrated a significant improvement in overall survival, compared with standard treatment (cetuximab with carboplatin or cisplatin plus 5-FU), in these patient populations. “Head and neck cancer remains a devastating disease with poor long-term

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LYNPARZA® (olaparib) More Than Doubled Median Radiographic Progression-Free Survival (rPFS) in BRCA1/2 or ATM Metastatic Castration-Resistant Prostate Cancer vs. Standard of Care (7.4 vs. 3.6 months)

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today presented detailed results from the Phase 3 PROfound trial in 387 men with metastatic castration-resistant prostate cancer (mCRPC) who have a mutation in their homologous recombination repair (HRR) genes and whose disease had progressed on prior treatment with new hormonal agent (NHA) treatments e.g. abiraterone or enzalutamide. The trial was designed to analyze men with mCRPC harboring HRR-mutated (HRRm) genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if LYNPARZA showed clinical benefit, a formal analysis was performed of the overall trial population of men with HRRm genes (BRCA1/2, ATM, CDK12 and 11 other HRRm genes). Results showed a statistically-significant and clinically-meaningful improvement with LYNPARZA in the primary endpoint of radiographic progression-free survival (rPFS) in BRCA 1/2 or ATM- mutated tumors reducing the risk of

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Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Showed Statistically Significant Increase in Pathological Complete Response Versus Chemotherapy as Neoadjuvant Therapy in Early-Stage Triple-Negative Breast Cancer (TNBC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from the pivotal neoadjuvant/adjuvant Phase 3 KEYNOTE-522 trial in patients with early-stage triple-negative breast cancer (TNBC). The trial investigated a regimen of neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy, followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with a regimen of neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen). Interim findings – which are from the first randomized trial of an anti-PD-1 therapy in the neoadjuvant/adjuvant setting for TNBC – are being presented today during the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2019 Congress (Abstract #LBA8). In the neoadjuvant phase, KEYTRUDA plus chemotherapy (n=401) resulted in a statistically significant increase in pathological complete response (pCR) versus chemotherapy (n=201), from 51.2% with neoadjuvant

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Final Study Results Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination Treatment in Advanced Endometrial Cancer Presented at ESMO 2019 Congress

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced final results from the full endometrial cancer cohort of KEYNOTE-146/Study 111 evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, an orally available kinase inhibitor discovered by Eisai. The primary endpoint was objective response rate (ORR) at week 24 as assessed by investigators per immune-related Response Evaluation Criteria in Solid Tumors (irRECIST). The findings are being presented today in a proffered paper presentation at the European Society for Medical Oncology (ESMO) 2019 Congress (Abstract #994O). “The results of this KEYTRUDA plus LENVIMA study are a welcome development in the treatment of women with advanced endometrial cancer, a patient group with an unmet medical need,” said Dr. Vicky Makker, principal investigator and medical oncologist, Memorial Sloan Kettering Cancer Center. KEYNOTE-146/Study 111 supported the U.S. Food and Drug Administration (FDA) approval

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LYNPARZA® (olaparib) Phase 3 PAOLA-1 Trial Significantly Increased Progression-Free Survival as First-Line Maintenance Treatment with Bevacizumab for Newly-Diagnosed Advanced Ovarian Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced detailed positive results from the Phase 3 PAOLA-1 trial showing LYNPARZA added to bevacizumab demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in women with newly-diagnosed advanced ovarian cancer who had a complete or partial response to first-line treatment with platinum-based chemotherapy and bevacizumab. The trial compared LYNPARZA when added to standard-of-care (SoC) bevacizumab versus bevacizumab alone in women in the first-line maintenance setting, irrespective of their genetic biomarker status or outcome from previous surgery. Investigator-assessed results showed LYNPARZA added to bevacizumab reduced the risk of disease progression or death by 41% and improved PFS to a median of 22.1 months versus 16.6 months for those treated with bevacizumab alone (HR 0.59 [95% CI, 0.49-0.72], p<0.0001). The sensitivity

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FDA Approves KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This marks the first U.S. approval for the combination of KEYTRUDA plus LENVIMA and the first time an anti-PD-1 therapy is approved in combination with a kinase inhibitor for advanced endometrial carcinoma in the U.S. Following submission on June 17, this is an accelerated approval reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to improve the efficiency of the review process for applications to ensure

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Pooled Analysis Continues to Show Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Improved Overall Survival Versus Chemotherapy Alone as First-Line Treatment for Patients with Advanced NSCLC Whose Tumors Do Not Express PD-L1

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that first-line treatment with KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy demonstrated improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) in a pooled analysis of a subgroup of patients with advanced nonsquamous and squamous non-small cell lung cancer (NSCLC) whose tumors do not express PD-L1 (tumor proportion score [TPS] <1%) from three randomized trials. Patients with nonsquamous NSCLC with EGFR or ALK genomic tumor aberrations were ineligible. Results – from KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (Cohort G) – were consistent with those observed in the overall study populations across all three trials. Findings were featured in an oral presentation at the IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain (Abstract #MA25.01).

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Pivotal New Data from Merck’s Broad Oncology Portfolio at ESMO 2019 Congress

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from its broad oncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, from Sept. 27-Oct. 1, 2019. More than 80 abstracts involving Merck cancer medicines and investigational candidates will be featured at the congress, spanning over 18 tumor types. Three of these abstracts – KEYTRUDA data in triple-negative breast cancer (TNBC), LYNPARZA data in prostate cancer and LYNPARZA data in ovarian cancer – were selected for inclusion in the ESMO Presidential Symposium sessions. “The breadth of data to be presented at ESMO reflect our company’s commitment to advance KEYTRUDA and the other medicines in our portfolio across cancer types and stages of disease to help improve outcomes for cancer patients,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck

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Merck Highlights New Data from Leading Lung Cancer Clinical Development Program at the IASLC 2019 World Conference on Lung Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from the company’s leading clinical development program in lung cancer will be presented at the IASLC 2019 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain from Sept. 7-10, 2019. More than 30 abstracts evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with other cancer therapies and as monotherapy, will be presented. Key data to be presented in non-small cell lung cancer (NSCLC) include new pooled findings from three trials – KEYNOTE-189, KEYNOTE-407 and KEYNOTE-021 (cohort G) - evaluating KEYTRUDA in combination with chemotherapy among a subgroup of patients whose tumors do not express PD-L1. Three-year overall survival (OS) data with KEYTRUDA monotherapy from KEYNOTE-024 will also be presented and was selected for inclusion in the official WCLC press program. “Our robust lung cancer clinical

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LYNPARZA® (olaparib) Phase 3 PAOLA-1 Trial Met Primary Endpoint as First-Line Maintenance Treatment with Bevacizumab for Advanced Ovarian Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 PAOLA-1 trial in women with advanced ovarian cancer. The trial, in the first-line maintenance setting, compared LYNPARZA added to standard-of-care bevacizumab versus bevacizumab alone in women with or without BRCA -gene mutations. The trial met its primary endpoint in the intent-to-treat (ITT)* population with a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for women taking LYNPARZA plus bevacizumab, versus those taking bevacizumab alone, as a first-line maintenance treatment following response to standard first-line platinum-based chemotherapy and bevacizumab. The results, including biomarker sub-group analyses, will be presented at a forthcoming medical meeting. The safety and tolerability profiles observed in PAOLA-1 were generally consistent with those known for each medicine. PAOLA-1 is the

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LYNPARZA® (olaparib) Phase 3 PROfound Trial in HRR Mutation-Selected Metastatic Castration-Resistant Prostate Cancer Met Primary Endpoint

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 PROfound trial of LYNPARZA in men with metastatic castration-resistant prostate cancer (mCRPC) who have an homologous recombination repair gene mutation (HRRm) and have progressed on prior treatment with new hormonal anticancer treatments (e.g. enzalutamide and abiraterone). Results from the trial showed a statistically-significant and clinically-meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) with LYNPARZA vs. enzalutamide or abiraterone in men with mCRPC selected for BRCA 1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. HRR gene mutations occur in approximately 25% of men diagnosed with mCRPC within which BRCA 1/2 and ATM form the majority. The safety and tolerability profile of LYNPARZA was generally consistent with previous trials. José Baselga, executive vice president, Oncology

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Merck’s KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy Met Primary Endpoint of Pathological Complete Response (pCR) in Pivotal Phase 3 KEYNOTE-522 Trial in Patients with Triple-Negative Breast Cancer (TNBC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-522 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of the dual-primary endpoints of pathological complete response (pCR) following the neoadjuvant part of the neoadjuvant/adjuvant study regimen in patients with triple-negative breast cancer (TNBC). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), KEYTRUDA in combination with chemotherapy demonstrated a statistically significant improvement in pCR rates compared with chemotherapy alone, regardless of PD-L1 status. A pathological complete response or pCR is defined as a lack of all signs of cancer in tissue samples analyzed following completion of neoadjuvant therapy and definitive surgery. Based on the recommendation of the DMC, the trial will continue without changes to evaluate the other dual-primary endpoint of event-free survival

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European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This recommendation, which applies to all IMDC risk groups, is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for KEYTRUDA in combination with axitinib compared to sunitinib. “For patients with advanced renal cell carcinoma, the prognosis is poor, with a five-year survival rate of less than 10%,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “The positive opinion adopted

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Merck and Eisai Receive Third Breakthrough Therapy Designation from FDA for KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) Combination Treatment

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with LENVIMA, the orally available kinase inhibitor discovered by Eisai, for the potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma (HCC) not amenable to locoregional treatment. This is the third Breakthrough Therapy designation for the KEYTRUDA plus LENVIMA combination and is based on updated interim results from the Phase 1b trial KEYNOTE-524/Study 116. An earlier interim analysis was presented at the American Association for Cancer Research (AACR) Annual Meeting 2019. The first two Breakthrough Therapy designations for the combination were in advanced and/or metastatic renal cell carcinoma and advanced and/or metastatic non-microsatellite instability-high (MSI-H)/proficient mismatch repair (pMMR)

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LYNPARZA® (olaparib) Phase 3 SOLO3 Trial Demonstrated a 72% Objective Response Rate in Patients with Platinum-Sensitive Relapsed Germline BRCA-mutated Advanced Ovarian Cancer Compared to 51% of Patients Receiving Chemotherapy

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada), today presented full results from the Phase 3 SOLO3 trial which evaluated LYNPARZA, compared to chemotherapy, for the treatment of platinum-sensitive relapsed patients with germline BRCA1/2 -mutated (g BRCA m) advanced ovarian cancer, who have received two more prior lines of chemotherapy. The results were presented at the 55 th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. The results from the trial showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) in the LYNPARZA arm compared to the chemotherapy arm (ORR; 72.2% for LYNPARZA vs 51.4% for chemotherapy; 95% CI: 1.40 to 4.58; p=0.002). The key secondary endpoint of progression-free survival (PFS) was also significantly increased in the LYNPARZA arm (13.4 months) compared to the chemotherapy arm (9.2 months; PFS HR 0.62 [p=0.013]). Summary of endpoints [i]  

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LYNPARZA® (olaparib) First-Line Maintenance Therapy Nearly Doubled the Time Without Disease Progression or Death in Phase 3 POLO Trial for Patients with Germline BRCA-Mutated Metastatic Pancreatic Cancer

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced detailed results from the Phase 3 POLO trial evaluating LYNPARZA tablets as a first-line maintenance monotherapy for patients with germline BRCA -mutated (g BRCA m) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease had not progressed following platinum-based chemotherapy. The results of the trial will be featured today in a press briefing at the 55 th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago and presented as a late-breaker oral presentation at 1:00 p.m. CDT during the plenary session (Abstract #LBA4). The results will also be published online simultaneously in the New England Journal of Medicine (NEJM) . Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for LYNPARZA compared to placebo, reducing the risk of disease progression or death by 47%

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Results Evaluating Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma to be Presented at 2019 ASCO Annual Meeting

First R andomized Phase 3 Trial Evaluating an Anti-PD-1 Therapy as Monotherapy and in Combination with Chemotherapy for First-Line Treatment of These Patients (KEYNOTE-062) KENILWORTH, N.J., June 1, 2019 – Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced full results from the pivotal Phase 3 KEYNOTE-062 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy and in combination with chemotherapy (cisplatin and either 5-fluorouracil or capecitabine) for the first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. These results, which represent the first Phase 3 data evaluating an anti-PD-1 therapy as a first-line treatment for this patient population, are being featured today as part of the official ASCO press program and will be presented on Sunday, June 2 during an oral abstract session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA4007). In addition to

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Five-Year Survival Data for Merck’s KEYTRUDA® (pembrolizumab) in Advanced Non-Small Cell Lung Cancer (NSCLC) from First KEYNOTE Trial at 2019 ASCO Annual Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of five-year efficacy and safety data for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the first KEYNOTE trial (Phase 1b KEYNOTE-001). In this study, KEYTRUDA demonstrated a five-year overall survival (OS) rate of 23.2% in treatment-naïve patients (n=101) and 15.5% in previously treated patients (n=449). Of note, the five-year OS rate among patients whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥50%) was 29.6% in treatment-naïve patients (n=27) and 25.0% in previously treated patients (n=138). These findings, which represent the longest follow-up for KEYTRUDA in lung cancer, will be highlighted at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA9015) during the official press program and presented during a poster discussion on Sunday, June 2. “Lung cancer is

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Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Improved Overall Survival as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma at Final Analysis of Pivotal Phase 3 KEYNOTE-048 Trial

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of the final analysis of the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy and in combination with chemotherapy, for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #6000). Data include the first-time presentation of certain overall survival (OS) hypotheses from the KEYTRUDA in combination with chemotherapy study arm based on PD-L1 expression and the KEYTRUDA monotherapy study arm in the total patient population. Results of an interim analysis were presented at the European Society for Medical Oncology (ESMO) 2018 Congress and demonstrated superior OS outcomes for KEYTRUDA in combination with chemotherapy in the total population and KEYTRUDA monotherapy in patients whose tumors expressed

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Merck Provides Update on Phase 3 KEYNOTE-119 Study of KEYTRUDA® (pembrolizumab) Monotherapy in Previously-Treated Patients with Metastatic Triple-Negative Breast Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-119 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC) did not meet its pre-specified primary endpoint of superior overall survival (OS) compared to chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine). Other endpoints were not formally tested per the study protocol because the primary endpoint of OS was not met. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies involving patients treated with KEYTRUDA monotherapy; no new safety concerns were identified. Results will be presented at an upcoming medical meeting. “Metastatic triple-negative breast cancer is an aggressive and challenging disease to treat, especially after progression on initial standard-of-care treatment,” said Dr. Roy

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New Research from Merck’s Broad Oncology Clinical Development Program to be Presented at 2019 ASCO Annual Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new research from the company’s broad oncology clinical development program will be presented at the 55 th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31-June 4. More than 140 abstracts have been accepted evaluating Merck’s medicines – including KEYTRUDA, Merck’s anti-PD-1 therapy, LYNPARZA (in collaboration with AstraZeneca) and LENVIMA (in collaboration with Eisai) – in over 25 types of cancer. LYNPARZA data include new findings in metastatic pancreatic cancer with the first presentation of results from the POLO study to be featured in the ASCO Plenary Session and press program. Additionally, new or updated overall survival (OS) findings for KEYTRUDA in non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), head and neck cancer, and gastric or gastroesophageal junction (GEJ) cancer will be presented. “Research from our broad oncology clinical

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Katie Couric Joins Merck and Cancer Advocates to Support Patients and Caregivers Through the Expansion of Your Cancer Game Plan (YCGP)

Merck today announced a collaboration with journalist, author and longtime cancer advocate, Katie Couric, to launch “With Love, Me,” a new feature of Merck’s U.S. patient awareness campaign, Your Cancer Game Plan . Couric will join the program, which showcases a series of heartfelt letters on WithLoveMe.com written by caregivers and cancer survivors to their former selves touching upon what they wished they had known – or needed to hear – when they were first coping with a cancer diagnosis. “A cancer diagnosis can be life-shattering. Having lost both my husband Jay and sister Emily to this disease, as well as my mother-in-law and too many friends, I know firsthand how traumatic and isolating it can be,” said Couric. “Finding a community of people going through similar situations can be incredibly useful and comforting to patients and caregivers alike. I’m thrilled to work with Merck to share these firsthand accounts, and I hope they will help families navigate these challenging

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Merck Provides Update on Phase 3 KEYNOTE-062 Trial Evaluating KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy for First-Line Treatment of Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced topline findings from the final analysis of the pivotal Phase 3 KEYNOTE-062 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy and in combination with chemotherapy (cisplatin and either 5-fluorouracil or capecitabine) for the first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. In the monotherapy arm of the study, KEYTRUDA met a primary endpoint by demonstrating noninferiority to chemotherapy, the current standard of care, for overall survival (OS) in the entire intention-to-treat (ITT) population of patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥1). In the combination arm of KEYNOTE-062, KEYTRUDA plus chemotherapy was not found to be superior for OS (CPS ≥1 or CPS ≥10) or progression-free survival (PFS) (CPS ≥1) compared with chemotherapy alone. The safety profile of KEYTRUDA was consistent with that previously observed

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Data for Merck’s KEYTRUDA® (pembrolizumab) Across Different Types of Advanced Lung Cancer Presented at AACR Annual Meeting 2019

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first-time presentation of results from a post-hoc analysis of patients with liver or brain metastases from the Phase 3 KEYNOTE-189 trial. This post-hoc analysis from KEYNOTE-189, which evaluated KEYTRUDA in combination with pemetrexed (ALIMTA ® ) and cisplatin or carboplatin in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) regardless of PD-L1 tumor expression and with no EGFR or ALK genomic tumor aberrations, was featured in an oral presentation (Abstract #CT043) at the American Association for Cancer Research (AACR) Annual Meeting 2019 in Atlanta, Georgia. Additionally, pooled data from the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials evaluating KEYTRUDA in patients with previously treated advanced small cell lung cancer (SCLC) will be highlighted today in the AACR plenary session and press conference (Abstract #CT073). Data from KEYNOTE-158 and KEYNOTE-028

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Selumetinib Granted U.S. Breakthrough Therapy Designation in Neurofibromatosis Type 1

AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational MEK 1/2 inhibitor selumetinib. This designation is for the treatment of pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) symptomatic and/or progressive, inoperable plexiform neurofibromas (PN), a rare, incurable genetic condition. José Baselga, executive vice president, oncology, AstraZeneca, said, “Selumetinib shows promise in the treatment of NF1-related plexiform neurofibromas, a rare and debilitating disease with no approved medications to date. The Breakthrough Therapy Designation acknowledges the significant unmet need of these patients and the potential benefit of selumetinib in this setting.” Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories,

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European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) for Six-Week Dosing Schedule Across All Current Monotherapy Indications

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a new extended dosing schedule for KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, for all approved monotherapy indications in the European Union (EU). In the EU, KEYTRUDA as monotherapy is currently approved for eight indications across five tumor types. The CHMP positive opinion supports a new recommended dose of 400 mg every six weeks (Q6W) delivered as an intravenous infusion over 30 minutes for KEYTRUDA monotherapy. If approved by the European Commission, the Q6W dose would be available in addition to the currently approved dose of KEYTRUDA 200 mg every three weeks (Q3W) infused over 30 minutes. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the EU, and a final decision is expected in the second

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LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion For Use in Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of LYNPARZA tablets, as monotherapy for the treatment of adult patients with germline BRCA 1/2-mutations ( BRCA m), who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy. Dave Fredrickson, executive vice president, oncology, AstraZeneca, said, “Despite progress in treating patients with advanced breast cancer, there remains a

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LYNPARZA® (olaparib) Reduced the Risk of Disease Progression or Death as First-Line Maintenance Treatment in Germline BRCA-Mutated Metastatic Pancreatic Cancer

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 POLO trial. Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with LYNPARZA versus placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. POLO is a randomized, double-blinded, placebo-controlled trial exploring the efficacy of LYNPARZA tablets as first-line maintenance monotherapy in patients with germline BRCA- mutated (g BRCA m) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease has not progressed on platinum-based chemotherapy. José Baselga, executive vice president, research and development, oncology, AstraZeneca, said, “This is the first positive Phase 3 trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need. Most patients are

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) Monotherapy for Third-Line Treatment of Patients with Advanced Small Cell Lung Cancer (SCLC)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with advanced small cell lung cancer (SCLC) whose disease has progressed after two or more lines of prior therapy. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the SCLC cohorts of the Phase 2 KEYNOTE-158 and Phase 1b KEYNOTE-028 trials. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 17, 2019. “There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only six percent overall,” said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. “KEYTRUDA has already been established as an

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Merck Provides Update on KEYNOTE-240, a Phase 3 Study of KEYTRUDA® (pembrolizumab) in Previously Treated Patients with Advanced Hepatocellular Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-240 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did not meet its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) compared with placebo plus best supportive care. In the final analysis of the study, there was an improvement in OS for patients treated with KEYTRUDA compared to placebo, however these OS results did not meet statistical significance per the pre-specified statistical plan (HR=0.78 [95% CI, 0.611-0.998]; p=0.0238). Results for PFS were also directionally favorable in the KEYTRUDA arm compared with placebo but did not reach statistical significance (HR=0.78 [95% CI, 0.61-0.99]; p=0.0209). The key secondary endpoint of objective response rate (ORR) was not formally

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KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) Reduced Risk of Death by Nearly Half Compared to Sunitinib as First-Line Treatment for Advanced Renal Cell Carcinoma (RCC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced presentation of the full results from the pivotal Phase 3 KEYNOTE-426 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced renal cell carcinoma (RCC) at the 2019 Genitourinary Cancers Symposium (ASCO GU) (Abstract #543). These data were also simultaneously published in the New England Journal of Medicine . This is the first combination regimen to significantly improve overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to sunitinib. Results were consistent across all IMDC subgroups, including favorable, intermediate and poor risk groups, and regardless of PD-L1 expression. As previously announced, the U.S. Food and Drug Administration (FDA) has granted priority review for a supplemental Biologics License Application (sBLA) for KEYTRUDA in

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Inlyta® (axitinib) as First-Line Treatment for Advanced Renal Cell Carcinoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This sBLA is based on findings from the Phase 3 KEYNOTE-426 trial, which demonstrated that KEYTRUDA in combination with axitinib, as compared to sunitinib, significantly improved overall survival (OS) and progression-free-survival (PFS) in the first-line treatment of advanced RCC. These data will be presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco on February 16. The sBLA also included supporting data from the Phase 1b KEYNOTE-035 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 20, 2019.

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Merck Increases Focus on Advanced Prostate Cancer, Expanding Immuno-Oncology Program with Three New Phase 3 Trials

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of interim data from the Phase 1b/2 KEYNOTE-365 umbrella trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with various agents for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). These early findings show anti-tumor activity across three cohorts of the study, which investigated KEYTRUDA in combination with LYNPARZA (Cohort A, Abstract #145); docetaxel and prednisone (Cohort B, Abstract #170); and enzalutamide (Cohort C, Abstract #171) – with a safety profile consistent with each therapy alone. These results are being presented today at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco. Based on the findings, Merck is initiating three new pivotal Phase 3 trials with KEYTRUDA in combination with LYNPARZA (KEYLYNK-010, NCT03834519), docetaxel and prednisone (KEYNOTE-921, NCT03834506) and enzalutamide

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Merck Highlights Breadth of Immuno-Oncology Research Program in Genitourinary Cancers at ASCO GU

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new combination and monotherapy data from the company’s broad immuno-oncology research program in genitourinary cancers – renal, prostate and bladder − will be presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in San Francisco from February 14-16. Survival data from the pivotal Phase 3 KEYNOTE-426 trial with KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of advanced or metastatic renal cell carcinoma (RCC) will be presented for the first-time (Abstract #543). In October 2018, Merck announced that KEYNOTE-426 met both primary endpoints of overall survival (OS) and progression-free survival (PFS), and the key secondary endpoint of objective response rate (ORR). Data released today from the first interim analysis showed KEYTRUDA in combination with axitinib, when compared to sunitinib, significantly

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This sBLA is based in part on data from the pivotal Phase 3 KEYNOTE-048 trial where KEYTRUDA demonstrated a significant improvement in overall survival compared with the standard of care, as monotherapy in patients whose tumors expressed PD-L1 with CPS≥20 and CPS≥1 and in combination with chemotherapy in the total patient population. These data were presented at the European Society for Medical Oncology 2018 Congress. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of

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Merck’s KEYTRUDA® (pembrolizumab) Reduced Risk of Death by 31 Percent Compared to Chemotherapy in Previously Treated Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Expressed PD-L1 (CPS ≥10)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of results from KEYNOTE-181, a Phase 3 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma. In this pivotal study, KEYTRUDA met a primary endpoint by significantly improving overall survival (OS) in patients with squamous cell carcinoma or adenocarcinoma who progressed after standard therapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10), with a 31 percent reduction in the risk of death compared to chemotherapy (paclitaxel, docetaxel or irinotecan) (HR=0.69 [95% CI, 0.52-0.93]; p=0.0074). This represents the first time an anti-PD-1 therapy has demonstrated a survival benefit for this patient population. The primary endpoint of OS was also evaluated in patients with squamous cell histology and in the entire intention-to-treat (ITT)

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Merck’s KEYTRUDA® (pembrolizumab) Receives Five New Approvals in Japan, Including in Advanced Non-Small Cell Lung Cancer (NSCLC), as Adjuvant Therapy for Melanoma, and in Advanced Microsatellite Instability-High (MSI-H) Tumors

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that KEYTRUDA, Merck’s anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA), including three expanded uses in advanced non-small lung cancer (NSCLC), one in melanoma, as well as a new indication in advanced microsatellite instability-high (MSI-H) tumors. The following new approvals were all granted priority review by the PMDA: KEYTRUDA in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-189); KEYTRUDA in combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of unresectable, advanced/recurrent squamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-407);

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Merck Provides Update on KEYTRUDA® (pembrolizumab) Supplemental Biologics License Application (sBLA) for KEYNOTE-042 Trial

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. The sBLA is based on results of the Phase 3 KEYNOTE-042 trial where KEYTRUDA monotherapy demonstrated a significant improvement in overall survival compared with chemotherapy in this patient population. The company recently submitted additional data and analyses to the FDA, which constitutes a major amendment and extends the Prescription Drug User Fee Act (PDUFA), or target action date, by three months to April 11, 2019. Merck continues to work closely with the FDA during the review of this sBLA.

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Adult and Pediatric Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma, a Rare Form of Skin Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC), based on the results of the Cancer Immunotherapy Trials Network (CITN)’s CITN-09/KEYNOTE-017 trial. In this Phase 2 trial of 50 patients with recurrent locally advanced or metastatic MCC who had not received prior systemic therapy for their advanced disease, KEYTRUDA monotherapy demonstrated an objective response rate of 56 percent (95% CI, 41-70), with a complete response rate of 24 percent (95% CI, 13-38) and a partial response rate of 32 percent (95% CI, 20-47). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical

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LYNPARZA® (olaparib) Approved by FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated (g BRCA m or s BRCA m) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Patients with g BRCA m advanced epithelial ovarian, fallopian tube or primary peritoneal cancer are selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. This is the first regulatory approval for a PARP inhibitor in the first-line maintenance setting for BRCAm advanced ovarian cancer. The approval was based on positive results from the pivotal Phase 3 SOLO-1 trial in which LYNPARZA reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer

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Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival (OS) Compared to Chemotherapy in Patients with Advanced Esophageal or Esophagogastric Junction Carcinoma Whose Tumors Express PD-L1 (CPS ≥10)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Phase 3 KEYNOTE-181 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in the second-line treatment of advanced or metastatic esophageal or esophagogastric junction carcinoma has met a primary endpoint of overall survival (OS) in patients whose tumors expressed PD-L1 (Combined Positive Score [CPS] ≥10). In this pivotal study, treatment with KEYTRUDA resulted in a statistically significant improvement in OS compared to chemotherapy (paclitaxel, docetaxel or irinotecan) in patients with CPS ≥10, regardless of histology. The primary endpoint of OS was also evaluated in patients with squamous cell histology and in the entire intention-to-treat (ITT) study population. While directionally favorable, statistical significance for OS was not met in these two patient groups. Per the statistical analysis plan, the key secondary endpoints of progression-free survival (PFS) and

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Early Phase 1 Data from Merck’s Oncology Pipeline for Investigational Anti-LAG-3 Therapy (MK-4280) and Anti-TIGIT Therapy (MK-7684) to Be Presented at SITC’s 33rd Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentations of preliminary safety and efficacy data from Phase 1/2 dose finding studies for the company’s investigational anti-LAG-3 therapy (MK-4280) and anti-TIGIT therapy (MK-7684) in patients with advanced solid tumors. LAG-3 and TIGIT are negative immune regulators and play different roles in downregulating the immune response. The preliminary findings from the studies demonstrated acceptable safety profiles with no dose limiting toxicities and early signals of anti-tumor activity for Merck’s anti-LAG-3 therapy (MK-4280) (Abstract #O26) and anti-TIGIT therapy (MK-7684) (Abstract #O25) as monotherapies and in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy. These early data will be presented Nov. 9th in oral sessions at SITC’s 33rd Annual Meeting. To date, Merck has presented early safety and efficacy data for six investigational therapies from its oncology

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) based on results from the KEYNOTE-407 trial. In the pivotal Phase 3 trial of patients regardless of tumor PD-L1 expression status, KEYTRUDA in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49, 0.85]; p=0.0017). This approval marks the first time an anti-PD-1 regimen has been approved for the first-line treatment of squamous NSCLC regardless of tumor PD-L1 expression status. “Today’s approval expands our current lung cancer indications to include combination

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European Medicines Agency Adopts Positive Opinion for Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy in Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with melanoma with lymph node involvement who have undergone complete surgical resection. This recommendation is based on data that demonstrated a significant improvement in recurrence-free survival (RFS) for KEYTRUDA in the pivotal Phase 3 EORTC1325/KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). These data were presented for the first time at the American Association for Cancer Research (AACR) Annual Meeting 2018 and published in The New England Journal of Medicine. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the

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SOLO-1 Phase 3 Trial Demonstrates LYNPARZA® (olaparib) Maintenance Therapy Cut the Risk of Disease Progression or Death by 70 Percent in Patients with Newly-Diagnosed, Advanced BRCA-Mutated Ovarian Cancer

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced detailed results from the Phase 3 SOLO-1 trial testing LYNPARZA 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA -mutated ( BRCA m) ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for LYNPARZA as compared to placebo, reducing the risk of disease progression or death by 70 percent (HR=0.30 [95% CI, 0.23-0.41]; p<0.001). At 41 months of follow-up, the median PFS for patients treated with LYNPARZA was not reached compared to 13.8 months for patients treated with placebo. Of those receiving LYNPARZA, 60.4 percent remained progression-free at 36 months, compared to 26.9 percent of women in the placebo arm. The data were presented at the

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First Presentation of Early Data for Merck’s Investigational STING Agonist (MK-1454) in Patients with Advanced Solid Tumors or Lymphomas at ESMO 2018 Congress

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of preliminary data from a Phase 1 clinical trial evaluating MK-1454, an investigational STING (stimulator of interferon genes) agonist, as monotherapy and in combination with KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced solid tumors or lymphomas. MK-1454 is one of more than 20 novel investigational immuno-therapeutic candidates Merck is evaluating as part of its broad oncology pipeline. The findings for MK-1454 were accepted as a late-breaking abstract and are being presented today in a poster discussion session at the ESMO 2018 Congress (Abstract #LBA15). “Merck is advancing a broad pipeline focused on the development of novel therapies with potential to provide meaningful clinical benefit to people with advanced cancers,” said Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

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Merck’s KEYTRUDA® (pembrolizumab) Showed a Complete Response Rate of Nearly 40 Percent in Patients with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Standard of Care

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of results from an interim analysis of KEYNOTE-057, a Phase 2 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for previously treated patients with high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) or CIS plus papillary disease (Cohort A). An interim analysis of the study’s primary endpoint showed a complete response (CR) rate of 38.8 percent (95% CI, 29.4-48.9) (n=103) at three months with KEYTRUDA in patients whose disease was unresponsive to Bacillus Calmette-Guérin (BCG) therapy, the current standard of care for this disease, and who were ineligible for or who refused to undergo radical cystectomy. These results, as well as other study findings, are being presented today in an oral session at the ESMO 2018 Congress (Abstract #864O). “Treatment options for high-risk non-muscle invasive bladder cancer have historically been limited, with

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Merck’s Broad Oncology Pipeline to Be Highlighted at ESMO 2018 Congress

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from Merck’s broad oncology portfolio and robust early pipeline will be presented at the European Society for Medical Oncology (ESMO) 2018 Congress in Munich, Germany from October 19-23. More than 100 abstracts involving Merck medicines – including eight late-breaking abstracts – across more than 15 tumor types have been accepted. Additionally, pivotal Phase 3 data evaluating anti-PD-1 therapy KEYTRUDA as a first-line treatment in patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) from the KEYNOTE-048 trial (Abstract #LBA8_PR) and the PARP inhibitor LYNPARZA (in collaboration with AstraZeneca) as maintenance therapy in newly diagnosed patients with BRCA -mutated ( BRCA m) advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy from the SOLO-1 trial (Abstract #LBA7_PR) are to be presented in the ESMO

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FDA Grants Priority Review to Merck’s Application for KEYTRUDA® (pembrolizumab) Monotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS ≥1%)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without  EGFR  or  ALK  genomic tumor aberrations. The application is based on data from the pivotal Phase 3 KEYNOTE-042 trial, one of five Phase 3 clinical trials with KEYTRUDA in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Jan. 11,

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European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALK Genomic Tumor Aberrations

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA, the company’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA ® ) and platinum chemotherapy for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK positive mutations. This approval, the first in Europe for an anti-PD-1 therapy in combination with chemotherapy, is based on data from the pivotal Phase 3 KEYNOTE-189 trial in patients with metastatic nonsquamous NSCLC regardless of PD-L1 tumor expression status, which demonstrated a significant survival benefit for the combination of KEYTRUDA with chemotherapy as compared with standard-of-care chemotherapy alone – reducing the risk of death in these patients by half (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). “We are very pleased that the European Commission has approved KEYTRUDA in combination with chemotherapy

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Data from Merck’s Leading Lung Cancer Research Program with KEYTRUDA® (pembrolizumab) to be Presented at IASLC 19th World Conference on Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that investigational data from the company’s leading lung cancer research program with KEYTRUDA, Merck’s anti-PD-1 therapy, will be presented at the IASLC 19th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Toronto from Sept. 23-26. More than 20 abstracts with KEYTRUDA in the treatment of non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and mesothelioma have been accepted for presentation. “Lung cancer is a top priority within Merck’s broad immuno-oncology development program with KEYTRUDA,” said Dr. Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories. “At the World Conference on Lung Cancer, we look forward to the presentation of KEYTRUDA data including findings across histologies, in combination with other cancer therapies, and in earlier stages

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Eisai and Merck Announce China National Medical Products Administration (NMPA) Approval of LENVIMA® (lenvatinib) for Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the China National Medical Products Administration (NMPA) approved the kinase inhibitor LENVIMA ® (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. In China, the application of LENVIMA was submitted in October 2017 and was designated for Priority Review by the NMPA due to LENVIMA's significant clinical benefit compared to existing treatments, leading to approval in approximately 10 months. This approval marks the first for LENVIMA in China, where the incidence of HCC is high, and the first new systemic therapy approved for the first-line treatment of unresectable HCC in China in ten years. “Over the past decade, there have been limited treatment options available for patients with unresectable HCC,” said Dr. Takashi Owa,

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for the Treatment of Merkel Cell Carcinoma, a Rare Form of Skin Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking accelerated approval for KEYTRUDA, Merck’s anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This sBLA is based on data from the Phase 2 KEYNOTE-017 trial including overall response rate (ORR) and duration of response (DOR); these data were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. In July 2017, KEYTRUDA was granted Breakthrough Therapy Designation by the FDA for this indication. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Dec. 28, 2018. “Merkel cell carcinoma, a rare type of skin cancer, is an aggressive and fast-growing disease that has been associated

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FDA Approves Expanded Label for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy for First-Line Treatment of Patients with Metastatic Nonsquamous NSCLC, with No EGFR or ALK Genomic Tumor Aberrations

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA ® ) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial. In the pivotal, Phase 3 KEYNOTE-189 trial of patients regardless of PD-L1 tumor expression status, KEYTRUDA in combination with pemetrexed and platinum chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001), reducing the risk of death by half compared to chemotherapy alone. The study also showed a significant improvement in progression-free survival (PFS) compared to chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64];

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Eisai and Merck Announce FDA Approval of LENVIMA® (lenvatinib) Capsules for First-line Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Approval was based on REFLECT, the first-ever positive Phase 3 trial against an active comparator in previously untreated patients with unresectable HCC Marks second approval under Eisai-Merck global collaboration to co-develop and co-commercialize LENVIMA, following Japan in March 2018 Woodcliff Lake, NJ and Kenilworth, NJ, Aug. 16, 2018 – Eisai Inc. and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA ® (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). This approval was based on results from REFLECT (Study 304), where LENVIMA demonstrated a proven treatment effect on overall survival (OS) by statistical confirmation of non-inferiority, as well as statistically significant superiority and clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR) when compared

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Selumetinib Granted Orphan Designation in Europe for Neurofibromatosis Type 1

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, today announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1). NF1 is an incurable genetic condition that affects one in 3,000 newborns worldwide. The severity of signs and symptoms associated with NF1 can be highly variable, are often mild-to-moderate and may include skin, nerve and skeletal manifestations. Plexiform neurofibromas (PNs) are benign tumors on nerve sheaths that develop in 20-50 percent of patients and, as they continue to increase in number and size, cause moderate-to-severe morbidities such as pain, motor dysfunction and disfigurement. Sean Bohen, executive vice president, global medicines development and chief medical officer, at AstraZeneca, said, “There is no cure for NF1, a life-long and devastating condition, and current treatment choices for these patients are very limited.

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Eisai and Merck Announce FDA Grants Breakthrough Therapy Designation for LENVIMA® (lenvatinib) in Combination with KEYTRUDA® (pembrolizumab) as Therapy for Previously Treated Patients with Advanced and/or Metastatic non-MSI-H/pMMR Endometrial Carcinoma

Eisai Co., Ltd. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for LENVIMA ® (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high (MSI-H)/proficient mismatch repair (pMMR) endometrial carcinoma (EC) who have progressed following at least one prior systemic therapy. The LENVIMA/KEYTRUDA combination therapy is being jointly developed by Eisai and Merck as part of the strategic collaboration announced in March 2018. This is the third Breakthrough Therapy designation for LENVIMA and the second Breakthrough Therapy designation for LENVIMA in combination with KEYTRUDA, following the Breakthrough Therapy designation for the combination for advanced and/or

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European Medicines Agency Adopts Positive Opinion for KEYTRUDA® (pembrolizumab) Combination with Pemetrexed and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer

KEYTRUDA Combination Improved Overall Survival Compared with Pemetrexed and Platinum Chemotherapy Alone in Pivotal Phase 3 Trial (KEYNOTE-189) Positive Opinion for KEYTRUDA Also Adopted for Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-040) Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA ® ) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression. If approved, this would mark the first approval in Europe for an anti-PD-1 therapy in combination with chemotherapy, and is based on overall

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KEYTRUDA® (pembrolizumab) Monotherapy Met a Primary Endpoint in the Phase 3 KEYNOTE-048 Trial, Significantly Improving OS as First-Line Therapy in Head and Neck Squamous Cell Carcinoma Patients Whose Tumors Expressed PD-L1 (CPS ≥20)

KEYTRUDA is the First Anti-PD-1 Therapy to Show an Overall Survival Benefit as First-Line Therapy for Recurrent or Metastatic HNSCC Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed PD-L1 (Combined Positive Score (CPS) ≥20). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with KEYTRUDA monotherapy in these patients resulted in significantly longer OS compared to cetuximab in combination with platinum chemotherapy (cisplatin or carboplatin) plus 5-Fluorouracil (5-FU), the current standard of care for HNSCC in the first-line treatment setting. At the time of the interim analysis, the dual-primary

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer

Application Based on Data from Pivotal Phase 3 KEYNOTE-407 Trial Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 3 KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2018. “KEYTRUDA has already been established as an important treatment option for non-small cell lung cancer in the first-line setting, and

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LYNPARZA® (olaparib) Approved in Japan for BRCA-Mutated Metastatic Breast Cancer

LYNPARZA is the First and Only PARP Inhibitor Approved for Use Beyond Ovarian Cancer Second Approval in Japan for AstraZeneca and Merck’s LYNPARZA AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved LYNPARZA ® (olaparib) tablets for use in patients with unresectable or recurrent BRCA -mutated ( BRCA m), human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received prior chemotherapy. Patients are selected for therapy based on an approved companion diagnostic. Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca, said, “Earlier this year, LYNPARZA became the first PARP inhibitor available in Japan for advanced ovarian cancer. Now patients in Japan with BRCA-mutated, metastatic breast cancer will also have the opportunity to benefit from LYNPARZA. This latest approval underlines our ongoing

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LYNPARZA® (olaparib) Significantly Delays Disease Progression in Phase 3 First-Line SOLO-1 Trial for Ovarian Cancer

LYNPARZA Met Primary Endpoint of Progression-Free Survival in Women with BRCA-Mutated Advanced Ovarian Cancer and Showed a Safety Profile Consistent with Previous Trials AstraZeneca and Merck's LYNPARZA is the Only PARP Inhibitor to Demonstrate Significant Activity in the First-Line Maintenance Setting AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of LYNPARZA ® (olaparib) tablets. Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions. Sean Bohen,

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FDA Accepts Supplemental Biologics License Application for Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Therapy in Advanced Melanoma

Application Based on Recurrence-Free Survival Data from Pivotal Phase 3 EORTC1325/KEYNOTE-054 Trial Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019. This sBLA is based on a significant benefit in recurrence-free survival demonstrated by KEYTRUDA in the pivotal Phase 3 EORTC1325/ KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). These data were presented for the first time at the American Association for Cancer Research (AACR) Annual Meeting 2018 and published in The New England Journal of Medicine.

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LYNPARZA® (olaparib) in Combination with Abiraterone Delayed Disease Progression in Metastatic Castration-Resistant Prostate Cancer

LYNPARZA is the First and Only PARP Inhibitor to Demonstrate Activity in Combination with Standard-of-Care Treatment in Prostate Cancer AstraZeneca and Merck Presented Results of Study 08 at 2018 ASCO Annual Meeting with Simultaneous Publication in The Lancet Oncology AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today presented data which showed clinical improvement in median radiologic progression-free survival (rPFS) with LYNPARZA ® (olaparib) in combination with abiraterone compared to abiraterone monotherapy, a current standard of care, in metastatic castration-resistant prostate cancer (mCRPC). LYNPARZA is being jointly developed and commercialized by AstraZeneca and Merck. The results of Study 08, a randomized, double-blinded, multi-center Phase 2 trial, comparing LYNPARZA in combination with abiraterone (n=71) to abiraterone monotherapy (n=71) in patients with previously-treated mCRPC, regardless of homologous recombination repair (HRR)

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Merck’s KEYTRUDA® (pembrolizumab) Demonstrated Long-Term Survival Benefit Based on Four and Five Years of Follow-Up from Two Pivotal Studies in Advanced Melanoma

New Analysis of Four-Year Data for KEYTRUDA from Phase 3 KEYNOTE-006 Study Showed 86 Percent of Patients Were Progression-Free 20 Months After Completing Two Years of KEYTRUDA Five-Year Data for KEYTRUDA from Phase 1b KEYNOTE-001 Study Showed Overall Survival Greater Than 40 Percent in Treatment-Naïve Metastatic Melanoma Patients, the Longest Follow-up for KEYTRUDA to Date Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced long-term efficacy data from the Phase 3 KEYNOTE-006 study and the melanoma cohort of the Phase 1b KEYNOTE-001 study investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with advanced melanoma. A new analysis from KEYNOTE-006 demonstrated durable efficacy benefits among patients who completed two years of KEYTRUDA treatment, combined with updated overall survival (OS) results across both studies, confirming anti-tumor activity in advanced melanoma patients. At a median follow-up of 20.3 months after completion of KEYTRUDA

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Eisai and Merck Announce Data at 2018 ASCO Annual Meeting from Investigational Studies of LENVIMA® (lenvatinib) and KEYTRUDA® (pembrolizumab) Combination Therapy in Four Different Tumor Types

First presentation of LENVIMA/KEYTRUDA data in patients with unresectable hepatocellular carcinoma (HCC), which aims to be the first systemic combination of a TKI and immunotherapy for these patients, as well as squamous cell carcinoma of the head and neck (SCCHN) Updated results show antitumor activity with a consistent safety profile in advanced renal cell carcinoma (RCC) and advanced endometrial carcinoma (EC) The LENVIMA/KEYTRUDA combination was recently granted U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for advanced RCC Phase 3 trials underway in advanced RCC (NCT02811861) and advanced EC (NCT03517449)  Woodcliff Lake, N.J. & Kenilworth, N.J., June 3, 2018 – Eisai Inc. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from presentations of new data and analyses of LENVIMA ® (lenvatinib), an orally available kinase inhibitor discovered by Eisai, in combination with Merck’s anti-PD-1 therapy,

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Merck’s KEYTRUDA® (pembrolizumab) Showed Overall Response Rate of Nearly 40 Percent as First-Line Therapy in Patients with Advanced Clear Cell Renal Cell Carcinoma (RCC) in Phase 2 KEYNOTE-427 Study

First-Time KEYTRUDA Monotherapy Data in Clear Cell RCC to be Presented at 2018 ASCO Annual Meeting Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced interim results from Cohort A of KEYNOTE-427, a Phase 2 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as first-line treatment for advanced clear cell renal cell carcinoma (RCC). Interim data showed an overall response rate (ORR) of 38.2 percent (95% CI, 29.1-47.9) in patients who received KEYTRUDA monotherapy as first-line therapy, the primary endpoint of the study. In a pre-specified, exploratory sub-group analysis based on PD-L1 status, ORR was 50.0 percent (95% CI, 34.9-65.1) in patients whose tumors expressed PD-L1 (CPS ≥1). In a pre-specified exploratory sub-group analysis based on the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk model, ORR was 42.0 percent (95% CI, 30.2-54.5) in patients with intermediate/poor prognostic risk. This is the first presentation

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Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Significantly Improved Overall Survival in First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer in Phase 3 KEYNOTE-407 Study

KEYTRUDA Combination Demonstrated Improved Overall Survival Regardless of PD-L1 Expression in Squamous NSCLC Results to be Presented Today at 2018 ASCO Annual Meeting Also Showed Significant Improvement in Progression-Free Survival for KEYTRUDA Combination Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-407, a pivotal, Phase 3 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC). In this study, the KEYTRUDA plus chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by 36 percent compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0008). This is the first time that a combination of an anti-PD-1 therapy and chemotherapy has significantly extended overall survival in the first-line treatment of patients with squamous NSCLC. These

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KEYTRUDA® (pembrolizumab) Monotherapy Significantly Improved Overall Survival in KEYNOTE-042 Study as First-Line Treatment for Locally Advanced or Metastatic NSCLC Patients Whose Tumors Expressed PD-L1 (TPS ≥1%)

Study Results Confirm KEYTRUDA is the Only Anti-PD-1 Therapy to Show an Overall Survival Benefit as Monotherapy in First-Line NSCLC KEYNOTE-042 to be Presented in Plenary Session at 2018 ASCO Annual Meeting Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-042, a pivotal, Phase 3 study evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations. In this study, KEYTRUDA monotherapy resulted in significantly longer overall survival (OS) than platinum-based chemotherapy (carboplatin plus paclitaxel or carboplatin plus pemetrexed) in patients with a PD-L1 tumor proportion score (TPS) of ≥1 percent. As part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of ≥50 percent (HR=0.69 [95% CI, 0.56-0.85];

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Eisai and Merck Provide Update on Supplemental New Drug Application (Snda) for Lenvatinib in First-line Unresectable Hepatocellular Carcinoma

Woodcliff Lake, NJ and Kenilworth, NJ, MAY 24, 2018 – Eisai Inc. and Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has extended the action date for the supplemental New Drug Application (sNDA) for lenvatinib for the potential first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The FDA has indicated that the extension of the Prescription Drug User Fee Act (PDUFA) date is needed to allow additional time for review of the application. The agency expects to complete the review on or before August 24, 2018, thus extending the target action date by a standard extension period of three months from the original PDUFA action date of May 24, 2018. Eisai, as the marketing authorization holder, is working closely with the FDA to support the continued review of this application. Lenvatinib (available as LENVIMA ® ) is approved by the U.S. FDA for the treatment of locally

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Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment for Squamous Non-Small Cell Lung Cancer (NSCLC) in Pivotal Phase 3 KEYNOTE-407 Trial

KEYTRUDA Has Now Demonstrated an Improved Survival Benefit in Advanced NSCLC in Five Phase 3 Trials Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel, as first-line treatment for metastatic squamous non-small cell lung cancer (sNSCLC), met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee (DMC), treatment with KEYTRUDA in combination with chemotherapy resulted in significantly longer OS and PFS than chemotherapy alone. The safety profile of KEYTRUDA in this combination was consistent with that previously observed in lung cancer. As previously announced, Merck has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and

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New Data from Merck’s Leading Immuno-Oncology Clinical Development Program in Over 25 Tumor Types to Be Presented at 2018 ASCO Annual Meeting

New and Long-term Overall Survival Data for KEYTRUDA ® (pembrolizumab) in Lung Cancer and Melanoma, Plus New Data in Renal Cell, Cervical, Merkel Cell, and Other Cancers First-Time Lynparza ® (olaparib) Data in Combination with Abiraterone in Metastatic Prostate Cancer Under Merck and AstraZeneca Strategic Collaboration New Data in Four Tumor Types Evaluating LENVIMA ® (lenvatinib) in Combination with KEYTRUDA Under Merck and Eisai Strategic Collaboration Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new combination and monotherapy data from Merck’s oncology portfolio, anchored by anti-PD-1 therapy KEYTRUDA, will be presented at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5. More than 140 abstracts in over 25 tumor types have been accepted, including new and long-term data for KEYTRUDA across multiple types of cancer. “With more data and longer follow-up across tumors

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LYNPARZA® (olaparib) Tablets Receive EU Approval for the Treatment of Platinum-Sensitive Relapsed Ovarian Cancer

Women with Platinum-Sensitive Ovarian Cancer Now Have Access to Maintenance Therapy with AstraZeneca and Merck’s LYNPARZA, Regardless of BRCA status LYNPARZA Has Over Five Years’ Efficacy and Safety Follow-Up Data New Tablet Formulation Reduces Dosing to Two Tablets Twice Daily AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Medicines Agency (EMA) has approved LYNPARZA® (olaparib) tablets (300 mg twice daily) for use as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA status. Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca, said, “With this new approval for LYNPARZA, we will now be able to offer more women with platinum-sensitive ovarian cancer, regardless of their BRCA status,

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Merck Provides Update on KEYNOTE-407 Trial

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-407 trial investigating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as first line treatment for metastatic squamous non-small cell lung cancer (sNSCLC) met a pre-specified secondary endpoint of overall response rate (ORR) in an early cohort of participants at an interim analysis. Based on these data, Merck has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). This study has been accepted for oral presentation at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The company now expects that an additional interim analysis will be conducted prior to ASCO and additional data may be available for the ASCO 2018 Annual Meeting. About KEYNOTE-407 KEYNOTE-407 (ClinicalTrials.gov, NCT 02775435) is a randomized,

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FDA Grants Priority Review to Merck’s sBLA for KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy Based on Results from Phase 3 KEYNOTE-189 Trial as First-Line Treatment of Metastatic Nonsquamous NSCLC

U.S. FDA Has Set a PDUFA Date of Sept. 23, 2018 Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA®, the company’s anti-PD-1 therapy, based on results of the Phase 3 KEYNOTE-189 trial. The application seeks approval for KEYTRUDA in combination with pemetrexed (ALIMTA®) and platinum chemotherapy (carboplatin or cisplatin) as a first-line treatment for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The FDA has granted Priority Review to this sBLA and has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2018. “KEYTRUDA is the first immunotherapy to significantly extend survival of patients with nonsquamous non-small cell lung cancer in combination with chemotherapy as a first-line treatment, including in patients whose tumors are either PD-L1 negative or are

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European Medicines Agency Validates Type II Variation for Merck’s KEYTRUDA® (pembrolizumab) in Combination with Pemetrexed (ALIMTA®) and Platinum Chemotherapy as First-Line Therapy in Metastatic Nonsquamous NSCLC, Based on Phase 3 KEYNOTE-189 Trial

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that following validation by the European Medicines Agency (EMA), the centralized review process has begun for the company’s Type II Variation, which seeks approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA ® ) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). The application was accepted for review based on overall survival (OS) and progression-free survival (PFS) data from the Phase 3 KEYNOTE-189 trial, which were recently presented at the American Association of Cancer Research (AACR) 2018 Annual Meeting and published simultaneously in The New England Journal of Medicine. If approved by the EMA, this would mark the third indication for KEYTRUDA in metastatic NSCLC to be approved in Europe based on overall survival data. “EMA’s acceptance of our

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Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed (ALIMTA®) and Platinum Chemotherapy Reduced the Risk of Death by Half Compared with Chemotherapy Alone as First-Line Treatment for Advanced Nonsquamous NSCLC in Phase 3 KEYNOTE-189 Study

KEYTRUDA Combination Improved Overall Survival in Patients Regardless of PD-L1 Expression, Including Patients Who Tested Negative for PD-L1 Results Presented Today at AACR 2018 and Published in The New England Journal of Medicine Also Show Significant Improvement in Progression-Free Survival, with Risk of Progression or Death Reduced by Nearly Half Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from KEYNOTE-189, a pivotal Phase 3 trial evaluating KEYTRUDA ® , Merck’s anti-PD-1 therapy, in combination with pemetrexed (ALIMTA ® ) and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC). Findings showed that the KEYTRUDA-pemetrexed-platinum chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by half compared with chemotherapy alone (HR=0.49 [95% CI, 0.38-0.64]; p<0.00001). In pre-specified exploratory analyses, an OS benefit was

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Updated Overall Survival Data for LYNPARZA® (olaparib) in gBRCA-mutated HER2-Negative Metastatic Breast Cancer Presented at AACR

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today presented data from the Phase 3 OlympiAD trial showing the final overall survival (OS) results for LYNPARZA in metastatic breast cancer at the American Association for Cancer Research (AACR) Annual Meeting in Chicago from April 14-18. The trial compared LYNPARZA with chemotherapy (physician’s choice of capecitabine, eribulin or vinorelbine) for patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer and met its primary endpoint of progression-free survival (PFS). Results at AACR include updated findings from the secondary endpoint of overall survival (OS). While the trial was not powered to demonstrate a statistically significant difference, the median OS was 19.3 months in patients treated with LYNPARZA and 17.1 months for patients treated with chemotherapy (HR 0.90, 95% CI 0.66-1.23; p=0.513). At the final OS data cutoff (64% maturity), 13 percent of patients

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Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Disease Recurrence or Death by More than 40 Percent Compared to Placebo as Adjuvant Therapy in Resected, High-Risk Stage III Melanoma

KEYTRUDA is First Anti-PD-1 Therapy to Show Recurrence-Free Survival (RFS) Benefit Across Stage IIIA (> 1 mm Lymph Node Metastasis), IIIB and IIIC Melanoma EORTC1325/KEYNOTE-054 Results Presented Today in Opening Plenary at AACR 2018 and Published in The New England Journal of Medicine Merck (NYSE:MRK), known as MSD outside the United States and Canada, and the European Organisation for Research and Treatment of Cancer (EORTC), today announced findings from the Phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA®, Merck’s anti-PD-1 therapy, as adjuvant therapy in resected, high-risk stage III melanoma. Study results showed KEYTRUDA significantly prolonged recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 43 percent compared to placebo in the overall study population (HR=0.57 [98.4% CI, 0.43-0.74]; p<0.0001). For the primary endpoint of RFS in the overall study population, the one-year RFS rate was 75.4 percent (95% CI, 71.3-78.9) for

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Incyte and Merck Provide Update on Phase 3 Study of Epacadostat in Combination with KEYTRUDA® (pembrolizumab) in Patients with Unresectable or Metastatic Melanoma

WILMINGTON, Del. and KENILWORTH, N.J. – April 6, 2018 –Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that an external Data Monitoring Committee (eDMC) review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte’s epacadostat in combination with Merck’s KEYTRUDA ® in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.  The study’s second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA. Incyte and Merck will inform investigators of the results

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The European Medicines Agency Accepts Regulatory Submission for LYNPARZA® (olaparib) in BRCA-Mutated HER2-Negative Metastatic Breast Cancer

If Approved, AstraZeneca and Merck’s LYNPARZA Would be the First PARP Inhibitor to Treat Patients with Breast Cancer in Europe AstraZeneca and Merck (NYSE:MRK), known as MSD outside the US and Canada, today announced that the European Medicines Agency has validated for review the Marketing Authorization Application (MAA) for LYNPARZA® (olaparib) for use in patients with deleterious or suspected deleterious BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. This is the first regulatory submission for a poly ADP-ribose polymerase (PARP) inhibitor in breast cancer in Europe. If approved, the identification of a patient’s BRCA status could become a critical step in the management of their disease alongside current consideration of their hormone receptor and HER2 status. The MAA is based on data from the randomized, open-label, phase 3 OlympiAD

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Pro Football Hall of Famer and Cancer Survivor Jim Kelly Joins Merck to Challenge America to Raise Funds for the Cancer Community

30-Day Your Cancer Game Plan Challenge Helps Those Impacted by Cancer and the Patient Organizations That Support Them With an estimated 1.6 million Americans diagnosed in 2017 alone, cancer not only impacts those diagnosed but their friends and family as well. In recognition of World Cancer Day on Sunday, Feb. 4, Merck (NYSE: MRK), known as MSD outside the United States and Canada, along with Pro Football Hall of Famer Jim Kelly is asking all Americans to join the Your Cancer Game Plan Challenge, a social awareness effort to help raise funds to support cancer patient organizations. The 30-day effort kicked off today as part of Your Cancer Game Plan, a comprehensive resource from Merck and the cancer advocacy community, to help cancer survivors and their loved ones manage the emotional, health and communication challenges of a cancer journey. “I know from personal experience that you can’t face a cancer diagnosis alone and that you need access to information and resources that can help

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First-Time Data for Merck’s KEYTRUDA® (pembrolizumab) in Patients with Previously Treated Advanced Hepatocellular Carcinoma (HCC) to be Presented at 2018 ASCO GI Symposium

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the registrational phase 2 KEYNOTE-224 trial investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced hepatocellular carcinoma (HCC), the most common type of liver cancer, who were previously treated with systemic therapy (sorafenib). Results showed an overall response rate (ORR) of 16.3 percent (95% CI, 9.8-24.9) (n=17/104) with KEYTRUDA as monotherapy. Data also include six-month overall survival (OS) and progression-free survival (PFS) rates. The findings will be presented at the 2018 American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium in San Francisco in an oral presentation on Friday, Jan. 19, from 1:10-1:15 p.m. PT (Location: Level 3 – Room 3014) (Abstract #209). “There continues to be a significant need for new options in the treatment of advanced hepatocellular carcinoma,” said Andrew Zhu, M.D.,

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Merck’s KEYTRUDA(R) (pembrolizumab) Significantly Improved Overall Survival and Progression-Free Survival as First-Line Treatment in Combination with Pemetrexed and Platinum Chemotherapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung...

KEYTRUDA is First PD1 Inhibitor in Combination to Show Overall Survival in NSCLC Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-189 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with pemetrexed (Alimta®) and cisplatin or carboplatin, for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), met its dual primary endpoints of overall survival (OS) and progression-free survival (PFS). Based on an interim analysis conducted by the independent Data Monitoring Committee, treatment with KEYTRUDA in combination with pemetrexed plus platinum chemotherapy resulted in significantly longer OS and PFS than pemetrexed plus platinum chemotherapy alone. The safety profile of KEYTRUDA in this combination was consistent with that previously observed. Results from KEYNOTE-189 will be presented at an upcoming medical meeting and submitted to

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Eisai and Merck Receive Breakthrough Therapy Designation from FDA for LENVIMA® (lenvatinib mesylate) and KEYTRUDA® (pembrolizumab) as Combination Therapy for Advanced and/or Metastatic Renal Cell Carcinoma

TOKYO and KENILWORTH, N.J. - Eisai Co., Ltd. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor LENVIMA ® (lenvatinib) in combination with Merck's anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic renal cell carcinoma (RCC). The LENVIMA and KEYTRUDA combination therapy is being jointly developed by Eisai and Merck. This is the second Breakthrough Therapy Designation for LENVIMA and the twelfth Breakthrough Therapy Designation granted to KEYTRUDA. The Breakthrough Therapy Designation is an FDA program intended to expedite development and review of drugs for serious or life-threatening conditions. In order to qualify for this designation, preliminary clinical evidence must demonstrate that the drug may provide substantial

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Merck’s KEYTRUDA® (pembrolizumab) Significantly Improved Recurrence-Free Survival Compared to Placebo as Adjuvant Therapy in Patients with Stage 3 Resected High-Risk Melanoma (EORTC1325/KEYNOTE-054)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and The European Organisation for Research and Treatment of Cancer (EORTC), today announced that the phase 3 EORTC1325/KEYNOTE-054 trial investigating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for surgically resected high-risk melanoma, met the primary endpoint of recurrence-free survival (RFS). Based on an interim analysis and following review by the Independent Data Monitoring Committee, post-resection adjuvant therapy with KEYTRUDA resulted in significantly longer recurrence-free survival than placebo (HR=0.57; 98.4% CI, 0.43-0.74; p In accordance with the trial protocol, the study will continue in order to evaluate other key endpoints, including overall survival. Results from EORTC1325/KEYNOTE-054 will be presented at an upcoming medical meeting, and submitted to regulatory authorities. “This has been a great collaboration between Merck and the EORTC and the findings from this interim

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Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Use in the Treatment of Patients with Urothelial Carcinoma That is Unresectable with Radical Surgery Who Have Progressed Following Cancer Chemotherapy

First Anti-PD-1 Therapy Approved in Japan for Previously-Treated Urothelial Carcinoma, a Type of Bladder Cancer Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy. The approval is based on data from the phase 3 KEYNOTE-045 trial, which demonstrated superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI, 0.59, 0.91], p=0.002). “Chemotherapy has long been the standard of care for advanced urothelial carcinoma, with few options available for patients whose disease progresses,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

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New and Updated Data for Merck’s KEYTRUDA® (pembrolizumab) and Updated Data on LYNPARZA® (olaparib) in Multiple Breast Cancer Subtypes to Be Presented at the 2017 San Antonio Breast Cancer Symposium (SABCS)

Efficacy Data from Phase 2 KEYNOTE-086 Trial, Cohort B, for KEYTRUDA Monotherapy in Patients with Untreated Metastatic Triple-Negative Breast Cancer to Be Featured in Spotlight Session Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new and updated data from six abstracts investigating KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, as both monotherapy and combination therapy, across a range of difficult-to-treat breast cancers, will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS), Dec. 5 – 9. In addition to the presentation of KEYTRUDA data at SABCS, updated data on LYNPARZA® (olaparib), the first-in-class poly ADP-ribose polymerase (PARP) inhibitor being co-developed and co-commercialized with AstraZeneca, will be presented. KEYTRUDA presentations include a Spotlight Session with findings from the phase 2 KEYNOTE-086 trial, Cohort B, investigating KEYTRUDA as a monotherapy in previously untreated patients

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AstraZeneca and Merck Rapidly Advance LYNPARZA® (olaparib) in Japan With a Second Regulatory Submission

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, today announced that they have submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of LYNPARZA ® (olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018. The Japan NDA is based on the positive results from the Phase III OlympiAD trial published in the New England Journal of Medicine. This is the second NDA for LYNPARZA in Japan where the medicine is currently under review for use in ovarian cancer, with a PMDA decision for this indication anticipated in the first half of 2018. LYNPARZA tablets are currently being tested in a range of tumor types in addition to ovarian and breast, including prostate and pancreatic cancers. IMPORTANT SAFETY INFORMATION DOSING AND ADMINISTRATION To avoid substitution errors and overdose, do not substitute LYNPARZA (olaparib) tablets with LYNPARZA

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New and Updated Clinical Data on Merck’s KEYTRUDA® (pembrolizumab) to Be Presented at 18th World Conference on Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new and updated data investigating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, across multiple lung (thoracic) malignancies, including non-small cell lung cancer (NSCLC), will be presented at the 18 th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan, Oct. 15-18. Results from studies in first-line NSCLC – updated overall survival findings from the phase 3 KEYNOTE-024 trial evaluating KEYTRUDA as a monotherapy (Abstract OA 17.06), and an encore of additional five months of follow-up from the randomized G cohort of the phase 2 KEYNOTE-021 trial evaluating KEYTRUDA in combination with pemetrexed/carboplatin (Abstract OA 17.01) – will be presented. Additional data in novel combinations and real-world evidence will also be shared. Merck has an extensive research program in NSCLC and is currently advancing

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Merck Announces Findings from Phase 3 Study of KEYTRUDA® (pembrolizumab), Compared to Standard of Care, in Patients with Previously Treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results of the phase 3 KEYNOTE-040 trial investigating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, compared to standard treatment (methotrexate, docetaxel or cetuximab) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. As previously disclosed, the study did not meet its pre-specified primary endpoint of overall survival (OS). The findings include updated survival data showing a 19 percent reduction in the risk of death over standard treatment in the intent-to-treat population (HR, 0.81 [95% CI, 0.66-0.99]; one sided p = 0.0204), with pre-specified p-value required for statistical significance of 0.0175, and a median OS of 8.4 months with KEYTRUDA (95% CI, 6.5-9.4) compared to 7.1 months with standard treatment (95% CI, 5.9-8.1). Complete results will be presented for the first

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Merck’s KEYTRUDA® (pembrolizumab) Continues to Show Overall Survival Benefit Over Chemotherapy with Nearly Two Years Follow-Up in Previously Treated Patients with Advanced Urothelial Carcinoma, Post-Platinum Failure

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced updated results from the phase 3 KEYNOTE-045 trial evaluating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial carcinoma (a type of bladder cancer) with disease progression on or after platinum-containing chemotherapy (post-platinum failure). Updated data show that with median follow-up of 22.5 months, KEYTRUDA continues to demonstrate an overall survival (OS) benefit over investigator’s choice of paclitaxel, docetaxel or vinflunine as a second-line therapy, post-platinum failure, regardless of PD-L1 expression (HR, 0.70 [95% CI, 0.57-0.86], p=0.0003). Findings are being presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, on Sunday, Sept. 10 (poster from 2:45 – 4:15 p.m. CEST; discussion: 3:15 – 3:45 p.m. CEST) (Location: Cordoba Auditorium) (Abstract #LBA37_PR). “These data at ESMO

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Merck’s KEYTRUDA® (pembrolizumab) Plus Pemetrexed and Carboplatin (pem/carbo) Demonstrated Continued Benefit in Overall Response Rates and Progression-Free Survival Compared to Pem/Carbo Alone in Patients with First-Line Nonsquamous NSCLC

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced updated results from Cohort G of the phase 2 KEYNOTE-021 trial investigating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed and carboplatin (pem/carbo) in patients with previously untreated advanced nonsquamous non-small cell lung cancer (NSCLC), with or without PD-L1 expression. With an additional five months of follow-up, significant improvements observed in prior analyses were maintained, including improvements in overall response rate (ORR) and progression-free survival (PFS) for KEYTRUDA + pem/carbo compared to pem/carbo alone. With a median of 18.7 months of follow-up, more than half of patients in the KEYTRUDA combination arm responded to treatment compared to approximately one-third in the pem/carbo arm (ORR of 56.7% vs. 31.7% [95% CI, 7.2-40.9], p=0.0029). The risk of progression or death continued to be reduced by nearly half with KEYTRUDA +

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Updated Data for Merck’s KEYTRUDA® (pembrolizumab) in Patients with Advanced Gastric Cancer Across Treatment Settings to Be Presented at ESMO 2017 Congress

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from all three cohorts of the registrational, phase 2 KEYNOTE-059 trial investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, including new data in treatment-naïve patients. Overall, results showed antitumor activity and durability of response with KEYTRUDA across multiple lines of therapy, with higher response rates observed in PD-L1-positive (CPS ≥1) patients: In heavily pre-treated patients, KEYTRUDA monotherapy (Cohort 1) showed an overall response rate (ORR) of 12 percent (95% CI, 8-17) in all patients and 16 percent (95% CI, 11-23) in patients with PD-L1 positive tumors. In treatment-naïve patients, KEYTRUDA in combination with chemotherapy (Cohort 2) showed an ORR of 60 percent (95% CI, 39-79) in all patients and 69 percent (95% CI, 41-89) in patients

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European Commission Approves Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, KEYTRUDA is approved for use as monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy, as well as adults who are not eligible for cisplatin-containing chemotherapy. The approval in patients previously treated with platinum-containing chemotherapy was based on superior overall survival (OS) for KEYTRUDA versus investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002), as demonstrated in the randomized, phase 3 KEYNOTE-045 trial. The approval in patients ineligible for cisplatin-containing chemotherapy was based on phase

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AstraZeneca and Merck Establish Strategic Oncology Collaboration

AstraZeneca and Merck & Co., Inc., (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib) for multiple cancer types. LYNPARZA is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment. LYNPARZA’s pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumor types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients. The companies will develop and commercialize LYNPARZA jointly, both as monotherapy and in combination trials with other potential medicines. Independently, the companies will develop and commercialize LYNPARZA in combinations with

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European Medicines Agency’s CHMP Recommends Approval for Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer

Recommendation is for Treatment in Adult Patients Who Have Received Prior Platinum- Containing Chemotherapy and for Adult Patients Who Are Not Eligible for Cisplatin-Containing Chemotherapy Positive Opinion is Based on Overall Survival Benefit Demonstrated in the Phase 3 KEYNOTE-045 Trial and Durable Responses Observed in the Phase 2 KEYNOTE-052 Trial Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Specifically, KEYTRUDA is recommended for the treatment of locally advanced or metastatic urothelial carcinoma in adult patients who have received prior platinum-containing chemotherapy, as well as adult patients who

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Merck Provides Update on Multiple Myeloma Studies KEYNOTE-183 and 185 of KEYTRUDA® (pembrolizumab) in Combination with Other Therapies

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today provided an update on two combination studies of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in the blood cancer multiple myeloma. Merck has accepted the external Data Monitoring Committee recommendation to pause new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring KEYTRUDA treatment in combination with other therapies in multiple myeloma. The pause is to allow for additional information to be collected to better understand more reports of death in the KEYTRUDA groups. Patients currently enrolled in these two studies will continue to receive treatment. Other studies of KEYTRUDA continue unchanged. KEYNOTE-183 is a Phase 3 study comparing pomalidomide and low-dose dexamethasone with KEYTRUDA to pomalidomide and low-dose dexamethasone alone in patients with refractory or relapsed and refractory multiple myeloma (rrMM) who have undergone at least 2 lines of prior treatment.

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FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Adult and Pediatric Patients with Unresectable or Metastatic, Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy. KEYTRUDA is now indicated for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) for Treatment of Recurrent or Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. The FDA granted Priority Review with a PDUFA, or target action, date of Sept. 22, 2017. “An estimated nearly one-hundred-thousand people are living with gastric cancer in the U.S., yet little progress has been made in bringing forward new treatment options to these patients for whom chemotherapy has long been the standard of care,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to working with the FDA to bring KEYTRUDA to people with

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Data for KEYTRUDA® (pembrolizumab) Across 16 Types of Cancer from Merck’s Industry-Leading Immuno-Oncology Program to Be Presented at the 2017 ASCO Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new and updated data from studies of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, will be presented at the 53 rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 2 – 6, 2017. At this year’s meeting, researchers will present data from more than 50 abstracts investigating the use of KEYTRUDA as monotherapy and in novel combinations across 16 cancers, including non-small cell lung cancer (NSCLC), melanoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancers, gastric cancer and breast cancer. Additional longer-term progression-free survival (PFS) and overall survival (OS) data for KEYTRUDA in monotherapy and as a combination therapy in first-line NSCLC from KEYNOTE-024 and KEYNOTE-021G will be presented. As noted in the abstracts, in KEYNOTE-024 significant improvement in OS was maintained with KEYTRUDA compared to chemotherapy with

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Incyte and Merck Provide Additional Details on Previously Announced Collaboration Investigating Epacadostat and KEYTRUDA® (pembrolizumab)

Clinical Program Now Includes Seven Registrational Trials Across Five Tumor Types WILMINGTON, Del. & KENILWORTH, N.J. – Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced additional details of their clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 enzyme inhibitor, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients across five tumor types: metastatic melanoma, non-small cell lung cancer (NSCLC), bladder cancer, renal cell carcinoma (RCC), and squamous cell carcinoma of the head and neck (SCCHN). The expanded collaboration now includes seven pivotal studies: A Phase 3 study in metastatic melanoma (trial underway); two Phase 3 studies in first-line NSCLC, including both PD-L1 high-expressing and PD-L1 unselected populations; two Phase 3 studies in bladder cancer, including one in first-line bladder cancer and one in second-line

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European Medicines Agency’s CHMP Recommends Approval of Merck’s KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Relapsed or Refractory Classical Hodgkin Lymphoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A decision on approval is expected in the second quarter of 2017. “This CHMP positive recommendation brings us one step closer to offering appropriate patients in the European Union with classical Hodgkin lymphoma a new treatment option to help fight this hematologic cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area

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FDA Accepts Two sBLAs for Merck’s KEYTRUDA® (pembrolizumab) for Locally Advanced or Metastatic Urothelial Cancer in Cisplatin-Ineligible First-Line and Second-Line Post-Platinum Failure Treatment Settings

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer. Specifically, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are ineligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for these patients with disease progression on or after platinum-containing chemotherapy. The PDUFA, or target action, date for both applications is June 14, 2017. “Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage

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European Commission Approves KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression with No EGFR or ALK Positive Tumor Mutations

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations. “The approval of KEYTRUDA as a first treatment instead of chemotherapy for patients who express high levels of PD-L1 has the potential to transform the way metastatic non-small cell lung cancer is treated,” said Dr. Roy Baynes, senior vice president, head of clinical development, and chief medical officer, Merck Research Laboratories. “We are committed to ensuring that patients in Europe – who are in need of new treatment options – are able to quickly gain access to KEYTRUDA.” The approval is based on phase 3 data which demonstrated superior overall survival (OS) and

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Pro Football Hall of Famer and Cancer Survivor Jim Kelly Teams Up with Merck and Leading Cancer Organizations to Launch Your Cancer Game Plan

Head and neck cancer survivor and Pro Football Hall of Famer Jim Kelly is sharing his personal experience as part of Your Cancer Game Plan, a new awareness campaign focused on helping people with cancer and their loved ones tackle their emotional, nutritional and communication needs. Kelly, one of the toughest quarterbacks to have played Pro Football, successfully handled the gridiron with his motto ‘Kelly Tough’ – a motto that took on new meaning after he was diagnosed with head and neck cancer. The campaign, from Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Kelly and leading cancer organizations, encourages people with head and neck cancer and their loved ones to make a cancer “game plan” to support their cancer journey. Many people living with head and neck cancer may experience different physical and emotional challenges than people with other forms of cancer. To help address these challenges, Your Cancer Game Plan provides support and

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Merck Receives FDA Acceptance of Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. This is the first application for regulatory approval of KEYTRUDA in combination with another treatment. The FDA granted Priority Review with a PDUFA, or target action, date of May 10, 2017. The sBLA will be reviewed under the FDA’s Accelerated Approval program. “Through our monotherapy and combination studies, we are working to find new approaches to help a broad range of patients with lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area

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Incyte and Merck to Advance Clinical Development Program Investigating the Combination of Epacadostat with KEYTRUDA® (pembrolizumab)

Additional pivotal studies evaluating Incyte’s IDO1 inhibitor in combination with Merck’s anti-PD-1 therapy in patients with non-small cell lung, renal, bladder and head and neck cancers expected to start in 2017 WILMINGTON, D.E. & KENILWORTH, N.J. – Incyte Corporation (Nasdaq:INCY) and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the decision to advance the clinical development program investigating the combination of epacadostat, Incyte’s investigational oral selective IDO1 inhibitor, with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy.  With the expansion of the clinical development program, the companies plan to initiate pivotal studies of epacadostat in combination with KEYTRUDA in four additional tumors:  non-small cell lung cancer, renal cell carcinoma, bladder cancer and squamous cell carcinoma of the head and neck. Presentations of data from the ongoing studies of epacadostat in combination with KEYTRUDA, which

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European Medicines Agency’s CHMP Recommends Merck’s KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression with No EGFR or ALK Positive Tumor...

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) with no EGFR or ALK positive tumor mutations. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union. A final decision is expected in the first quarter of 2017. KEYTRUDA is currently approved in Europe for the second-line treatment of patients with locally advanced or metastatic NSCLC whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumor mutations should also have received

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Interim Results from Phase 1b/2 Study Evaluating the Combination of Merck’s KEYTRUDA® (pembrolizumab) and Eisai’s HALAVEN® (eribulin mesylate) Injection in Metastatic Triple-Negative Breast Cancer Presented at 2016 SABCS

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced new interim data investigating Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), in combination with Eisai’s microtubule dynamics inhibitor, HALAVEN ® (eribulin), in patients with metastatic triple-negative breast cancer (TNBC). Findings presented during the 2016 San Antonio Breast Cancer Symposium (SABCS) were based on interim data from 39 evaluable patients and showed an overall response rate (ORR) of 33.3% (n=13/39; 95% CI, 19.5-48.1), with one complete response and 12 partial responses (Abstract #: P5-15-02). ORR was similar between PD-L1-positive and -negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1); PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. HALAVEN and KEYTRUDA are not approved for use in combination. The most common treatment-emergent adverse events (incidence greater than or equal to 35%) for the combination regimen were fatigue (n=29; 74.4%),

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KEYTRUDA® (pembrolizumab) Demonstrated Improved Health-Related Quality of Life Compared to Chemotherapy in First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive health-related quality of life (HRQoL) findings from an exploratory analysis from the phase 3 KEYNOTE-024 study investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, compared to standard of care (SOC) platinum-containing chemotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (tumor proportion score [TPS] of 50 percent or more). Specifically, patient-reported outcomes showed clinically meaningful improvement with KEYTRUDA compared to chemotherapy. Findings will be presented today at the 17 th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer. “The patient-reported quality of life outcomes we are seeing in the KEYNOTE-024 study are very encouraging and, coupled with previously reported clinical data from this

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Updated KEYTRUDA® (pembrolizumab) Data in Small Cell Lung Cancer and Mesothelioma Presented at 17th World Conference on Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that updated findings from the phase 1b KEYNOTE-028 study investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in previously treated patients with advanced small cell lung cancer (SCLC) and malignant pleural mesothelioma, showed clinical activity and durable responses in some patients. These data were featured in oral presentations at the 17 th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. “As data from our initial trials exploring KEYTRUDA mature, we are encouraged to see durable clinical activity in difficult-to-treat cancers such as small cell lung cancer and malignant pleural mesothelioma, where new treatments are clearly needed,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “With our extensive immuno-oncology research

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KEYTRUDA® (pembrolizumab) Treatment Results in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) Presented at 58th Annual Meeting of the American Society of Hematology

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today updated findings evaluating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in two trials of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). In the KEYNOTE-087 and KEYNOTE-013 trials, KEYTRUDA demonstrated overall response rates (ORR) of 69.0 percent and 58 percent, respectively. KEYNOTE-013, which had a median follow up of 29 months, showed responses of 12 months or greater in 70 percent of patients who responded to therapy. These findings will be presented today at the 58 th Annual Meeting of the American Society of Hematology (ASH). Additionally, data from these trials supported the recently announced regulatory filing with the U.S. Food and Drug Administration. “As the data mature from these two studies, we continue to be encouraged by the response rates, including complete remission and durable responses, in patients with relapsed or refractory classical

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Updated KEYTRUDA® (pembrolizumab) Findings in Patients with Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma Presented at 58th Annual Meeting of the American Society of Hematology

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today study findings demonstrating that KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, achieved an overall response rate (ORR) of 41 percent (n=7/17) (90% CI, 21-64) with follow-up of up to 27 months in patients with relapsed or refractory primary mediastinal large B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma, who were ineligible for or failed to respond to autologous stem-cell transplantation (ASCT). In patients treated with KEYTRUDA, 86 percent of responses (n=6/7) were ongoing at the time of analysis with the median duration of response not yet reached (range: 2 to 23 months). These updated findings, from the ongoing phase 1b KEYNOTE-013 study, will be presented today at the 58 th Annual Meeting of the American Society of Hematology (ASH) in San Diego (Abstract #619). Preliminary findings from this cohort were first presented at the 2015 ASH Annual Meeting. “For patients with

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FDA Grants Priority Review to Supplemental Biologics License Application (sBLA) for Merck’s KEYTRUDA® (pembrolizumab) in Relapsed or Refractory Classical Hodgkin Lymphoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or for patients who have relapsed after three or more prior lines of therapy. The FDA granted Priority Review with a PDUFA, or target action, date of March 15, 2017. The sBLA will be reviewed under the FDA’s Accelerated Approval program. In April 2016, KEYTRUDA was granted Breakthrough Therapy Designation by the FDA for this indication. “Patients with refractory or relapsed classical Hodgkin lymphoma have limited treatment options,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We believe that the expedited review of this sBLA granted by the FDA is

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New KEYTRUDA® (pembrolizumab) Data to be Presented at 17th World Conference on Lung Cancer Highlight Research Across the Spectrum of Thoracic Malignancies

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, across multiple thoracic malignancies, including non-small cell lung cancer (NSCLC), small cell lung cancer and malignant pleural mesothelioma, will be presented at the 17 th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Vienna, Austria, Dec. 4-7 (Messe Wien Exhibition & Congress Center). An abstract evaluating quality of life outcomes in first-line NSCLC from KEYNOTE-024 (Abstract #PL04a.01) will be included in the official WCLC press program on Wednesday, Dec. 7. “Based on the meaningful results already obtained in studies evaluating the use of KEYTRUDA in certain patients with PD-L1 positive non-small cell lung cancer, we have asked whether similar benefits might be associated with KEYTRUDA use in treating other intrathoracic

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Actress Bellamy Young, Merck, and Leading Lung Cancer Advocates Urge Those Impacted by Lung Cancer to Test. Talk. Take Action.

Acclaimed actress and singer Bellamy Young lost her father to lung cancer, and she is now sharing her personal experience as part of Test. Talk. Take Action ., a new awareness campaign focused on increasing people’s understanding of biomarkers and the role they play in the treatment of non-small cell lung cancer (NSCLC). The campaign – led by Merck (NYSE:MRK), known as MSD outside the United States and Canada, in partnership with Young and leading lung cancer advocacy groups – encourages those impacted by NSCLC to learn about biomarkers and talk with their health care provider about testing. Biomarkers, substances that can be found in cancer cells, give doctors a more well-defined picture of a patient’s lung cancer. In addition to being used to diagnose cancer, testing for biomarkers can help doctors make informed decisions about the most appropriate treatment for a patient’s lung cancer. There are several different biomarkers that can be used to plan treatment in NSCLC. These include

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FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) Seeking Approval for KEYTRUDA® (pembrolizumab) for New Indication in Microsatellite Instability-High Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of previously treated patients with advanced microsatellite instability-high (MSI-H) cancer. The FDA granted Priority Review with a PDUFA, or target action date, of March 8, 2017; the sBLA will be reviewed under the FDA’s Accelerated Approval program based on tumor response rate and durability of response. The FDA recently granted Breakthrough Therapy Designation to KEYTRUDA for unresectable or metastatic MSI-H non-colorectal cancer, and previously granted it for the treatment of patients with unresectable or metastatic MSI-H colorectal cancer. “The FDA’s acceptance of this application represents an important advance for the field of immuno-oncology and is further evidence of Merck’s commitment to

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Merck’s KEYTRUDA® (pembrolizumab) Significantly Improves Overall Survival Compared to Chemotherapy in Previously Treated Patients with Advanced Bladder (Urothelial) Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the pivotal KEYNOTE-045 study investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with advanced bladder (urothelial) cancer previously treated with platinum-containing chemotherapy. As previously announced, KEYTRUDA was superior to investigator-choice chemotherapy for the primary endpoint of overall survival (OS) in this phase 3 study, and was stopped early. Specifically, there was a 27 percent reduction in the risk of death in patients treated with KEYTRUDA compared to chemotherapy (OS, HR = 0.73, p-value: 0.0022). Data presented at the Society for Immunotherapy of Cancer’s (SITC) 31 st Annual Meeting are the first publicly presented findings from this study. “The improved overall survival for patients receiving KEYTRUDA in this trial are clinically significant and could impact how physicians consider treating patients with previously treated

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New KEYTRUDA® (pembrolizumab) Data Accepted for Presentation at SITC 2016 Annual Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer will be presented at the Society for Immunotherapy of Cancer’s (SITC) 31 st Annual Meeting, Nov. 9-13. Data on overall survival (OS) and progression-free survival (PFS) from the phase 3 KEYNOTE-045 study – investigating KEYTRUDA compared to investigator’s choice chemotherapy in patients with metastatic or locally advanced or unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy – will be presented for the first time; these data were accepted as a late-breaking abstract. In addition, results from three different studies exploring the utility of various biomarkers for KEYTRUDA will be presented at the meeting. KEYTRUDA Data at SITC 2016 Below is a select listing of the KEYTRUDA abstracts accepted

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Merck’s KEYNOTE-045 Studying KEYTRUDA® (pembrolizumab) in Advanced Bladder Cancer (Urothelial Cancer) Meets Primary Endpoint and Stops Early

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the phase 3 KEYNOTE-045 trial investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival (OS). In this trial, KEYTRUDA was superior compared to investigator choice chemotherapy. Based on a pre-specified interim analysis, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped early. “The results of KEYNOTE-045 represent a major breakthrough and will be welcome news for patients dealing with previously treated advanced urothelial cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We look forward to sharing the findings from this study with the medical community and with regulatory authorities around the world.” The safety profile of KEYTRUDA in this trial was consistent with that observed in previously

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Two Major Studies to Be Presented at ESMO 2016 Congress Presidential Symposium Demonstrate Potential of Merck’s KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer in a Broad Range of Patients

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from two major studies of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology: In KEYNOTE-024, which evaluated squamous and non-squamous NSCLC patients whose tumors expressed high levels of PD-L1 (tumor proportion score, or TPS, of 50 percent or more), KEYTRUDA provided a 50 percent reduction in the risk of disease progression or death and a 40 percent reduction in the risk of death compared to platinum doublet, the current standard of care. These data were also published today in The New England Journal of Medicine. Based upon the results observed from KEYNOTE-024, to date KEYTRUDA is the only anti-PD-1 to demonstrate superior progression-free survival (PFS) and overall survival (OS) compared to

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KEYTRUDA® (pembrolizumab) Showed Continued Overall Survival Benefit Compared to Chemotherapy with Longer Follow-Up in Patients with Previously Treated Metastatic Non-Small Cell Lung Cancer in Data to Be Presented at ESMO 2016 Congress

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, demonstrated superiority in overall survival (OS) at 18 months compared to standard of care chemotherapy (docetaxel) in patients with metastatic non-small cell lung cancer (NSCLC) previously treated with platinum-containing chemotherapy whose tumors expressed PD-L1 (tumor proportion score [TPS] of one percent or more), as well as patients with high levels of PD-L1 expression (TPS of 50 percent or more). These data, from the phase 2/3 KEYNOTE-010 trial, will be presented at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology, in Copenhagen (Abstract #LBA48). “These findings – which show superior survival with longer follow-up across patients with PD-L1 expression (tumor proportion score of one percent or more), as well as improved quality of life – point to KEYTRUDA as a durable treatment option for

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Merck Announces Longer-Term Follow-Up of Overall Survival Data for KEYTRUDA® (pembrolizumab) in Patients with Advanced Melanoma from KEYNOTE-002 Presented at ESMO 2016 Congress

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from the final overall survival (OS) analysis from the KEYNOTE-002 study investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, compared to investigator-choice chemotherapy with a crossover to KEYTRUDA design, in patients with ipilimumab-refractory advanced melanoma. Results presented at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology, in Copenhagen include follow-up of up to 35 months for the study’s co-primary endpoints of OS and progression-free survival (PFS). Data showed prolonged OS with KEYTRUDA (2 mg/kg and 10 mg/kg), with a median OS of 13.4 months and 14.7 months and a two-year OS rate of 35.9 percent and 38.2 percent, respectively, compared to a median OS of 11.0 months and a two-year OS rate of 29.7 percent with chemotherapy. “Now, with longer follow-up, we continue to show clinically meaningful outcomes with

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New KEYTRUDA® (pembrolizumab) Data in Advanced Urothelial Cancer Demonstrate Overall Response Rate of 24 Percent in Cisplatin-Ineligible Patients

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive findings from the phase 2 KEYNOTE-052 study investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in previously untreated patients with unresectable (inoperable) or metastatic urothelial cancer who are ineligible for cisplatin-based therapy. Data presented at the ESMO 2016 Congress, the annual meeting of the European Society for Medical Oncology, showed an overall response rate (ORR) of 24 percent (n=24/100) (95% CI, 16-34) in the total study population, which included patients with and without PD-L1 expression. “We have a growing body of evidence of KEYTRUDA’s activity in a range of cancers and treatment settings including the first-line treatment of patients with advanced urothelial cancer who will not tolerate cisplatin-based therapy,” said Dr. Roger Dansey, senior vice president, oncology late-stage development, Merck Research Laboratories. The KEYTRUDA

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Two New Trials of Merck’s KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer to be Presented During Presidential Session at ESMO 2016

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that extensive data on KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, have been accepted for presentation at the European Society for Medical Oncology (ESMO) 2016 Congress in Copenhagen, Denmark, Oct. 7 – 11. In total, findings from 30 studies in 12 cancers from Merck’s industry-leading clinical development program for KEYTRUDA – both as monotherapy and in combination – will be presented at this year’s ESMO. Two studies of KEYTRUDA in first-line treatment of advanced lung cancer have also been selected for presentation at the Presidential Symposium on Oct. 9: KEYNOTE-024, which studied KEYTRUDA as monotherapy compared to chemotherapy in patients whose tumors express high levels of PD-L1 (tumor proportion score of 50 percent or more), and KEYNOTE-021G, which studied KEYTRUDA plus chemotherapy (carboplatin and pemetrexed) compared to chemotherapy alone in all patients with non-squamous

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FDA Accepts Supplemental Biologics License Application, Assigns Priority Review and Grants Breakthrough Therapy Designation to Merck’s KEYTRUDA® (pembrolizumab) for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA, or target action, date of Dec. 24, 2016. Additionally, the FDA granted Breakthrough Therapy Designation for this indication. Merck has also submitted a Marketing Authorization Application to the European Medicines Agency for this indication. The submissions were based on data from the pivotal phase 3 KEYNOTE-024 study, which showed that KEYTRUDA monotherapy resulted in superior progression-free survival (PFS) as well as overall survival (OS) compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score

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Merck’s KEYTRUDA® (pembrolizumab) Approved by the European Commission for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Express PD-L1

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2 mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. Patients with EGFR or ALK positive tumor mutations should also have received approved therapy for these mutations prior to receiving KEYTRUDA. The EC approval allows marketing of KEYTRUDA in all 28 EU member states. The approval is based on findings from KEYNOTE-010, a pivotal study which showed KEYTRUDA significantly improved overall survival (OS) compared to standard of care chemotherapy. “This approval provides an important new treatment regimen for patients in Europe with advanced lung cancer, one of the most common and challenging cancers,” said Dr. Roger Dansey,

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Merck and Moderna Announce Strategic Collaboration to Advance Novel mRNA-Based Personalized Cancer Vaccines with KEYTRUDA® (pembrolizumab) for the Treatment of Multiple Types of Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Moderna Therapeutics today announced a strategic collaboration and license agreement to develop and commercialize novel messenger RNA (mRNA)-based personalized cancer vaccines. The collaboration will combine Merck’s established leadership in immuno-oncology with Moderna’s pioneering mRNA vaccine technology and GMP manufacturing capabilities to advance individually tailored cancer vaccines for patients across a spectrum of cancers. Moderna and Merck will develop personalized cancer vaccines that utilize Moderna’s mRNA vaccine technology to encode a patient’s specific neoantigens, unique mutations present in that specific patient’s tumor. When injected into a patient, the vaccine will be designed to elicit a specific immune response that will recognize and destroy cancer cells. The companies believe that the mRNA-based personalized cancer vaccines’ ability to specifically activate an individual patient’s immune

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Merck Receives CHMP Positive Opinion for KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. The CHMP positive opinion for KEYTRUDA will now be reviewed by the European Commission for marketing authorization in the European Union (EU). “This news marks an important step in making KEYTRUDA available for appropriate patients suffering from locally advanced or metastatic non-small cell lung cancer,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are grateful to patients and investigators around the world

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Merck’s KEYTRUDA® (pembrolizumab) Demonstrates Superior Progression-Free and Overall Survival Compared to Chemotherapy as First-Line Treatment in Patients with Advanced Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the KEYNOTE-024 trial investigating the use of KEYTRUDA ® (pembrolizumab), in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more), met its primary endpoint. In this trial, KEYTRUDA was superior compared to chemotherapy for both the primary endpoint of progression-free survival (PFS), and the secondary endpoint of overall survival (OS). Based on these results, an independent Data Monitoring Committee (DMC) has recommended that the trial be stopped, and that patients receiving chemotherapy in KEYNOTE-024 be offered the opportunity to receive KEYTRUDA. “We believe that the KEYNOTE-024 results have the potential to change the therapeutic paradigm in first-line treatment of non-small-cell lung cancer,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We look

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KEYTRUDA® (pembrolizumab) Shows Overall Response Rates of 73 to 83 Percent, with Complete Response Rates of 27 to 30 Percent, in Heavily Pre-treated Patients with cHL, in Update to Study KN-087

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first-time presentation of findings from KEYNOTE-087, the phase 2 study investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). These data will be presented today at the 52 nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from 8:00 – 11:30 a.m. CDT (Location: Hall A) and in a poster discussion from 1:15 – 2:45 p.m. CDT (Location: E354b) (Abstract #7555). Results included an analysis of outcome measurements from the study’s three patient cohorts: patients whose disease progressed following an autologous stem cell transplantation and subsequent treatment with brentuximab vedotin, an antibody drug conjugate (Cohort 1); patients who failed salvage chemotherapy and were ineligible for a transplant and whose disease progressed following treatment with

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Updated Findings from KEYNOTE-012 for KEYTRUDA® (pembrolizumab) Show Continued Benefit in Response Rates and Duration of Response Lasting Up to 30 Months in Patients with Previously Treated Recurrent or Metastatic Head and Neck Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new data with KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy from two studies (KEYNOTE-012 and KEYNOTE-055) in heavily pre-treated patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Data are being presented at the 52 nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. In KEYNOTE-012, for the primary endpoint, findings showed an overall response rate (ORR) of 18 percent (n=34/192) (95% CI, 13-24). At the time of analysis, 65 percent of responders (n=22/34) were continuing to respond – with responses observed in some patients for more than 30 months; median duration of response had not yet been reached. The secondary endpoint results showed a median overall survival (OS) rate of eight months (95% CI, 6-10) (Abstract #6012). The phase 1b KEYNOTE-012 study was the first clinical study investigating the role of a

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New Data for KEYTRUDA® (pembrolizumab) in Combination with Talimogene Laherparepvec, Dabrafenib Plus Trametinib, or Low-Dose Ipilimumab in Advanced Melanoma Presented at 2016 ASCO Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced findings from three separate studies evaluating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with other treatment regimens including talimogene laherparepvec, dabrafenib plus trametinib, or low-dose ipilimumab in patients with advanced melanoma. These data, from MASTERKEY-265, KEYNOTE-022, and KEYNOTE-029, respectively, are included in the 52 nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (Abstracts #9568, #3014, and #9506). “We continue to build on our leadership in advanced melanoma by evaluating KEYTRUDA with multiple combination partners utilizing diverse mechanisms of action with the goal of improving outcomes while maintaining tolerability,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “These encouraging early data point to the

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New KEYTRUDA® (pembrolizumab) Data from KEYNOTE-010 and KEYNOTE-001 in Advanced Non-Small Cell Lung Cancer, Including Survival Data, To Be Presented at 2016 ASCO Annual Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data, including updated response rates, progression-free survival (PFS) and overall survival (OS) with KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy in patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1 from two studies: KEYNOTE-010 and KEYNOTE-001. The findings are being presented at the 52 nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (Abstracts #9015 and #9026). A sub-analysis from the phase 2/3 KEYNOTE-010 trial includes OS data with KEYTRUDA compared to chemotherapy in previously treated patients with advanced NSCLC based on varying levels of PD-L1 expression; other data from KEYNOTE-010 are currently under review by the U.S. Food and Drug Administration (FDA) and are intended to serve as the basis for the full approval of KEYTRUDA in lung cancer in patients whose tumors express PD-L1.

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New Data Evaluating KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer Demonstrate Response Rates Ranging from 48 to 71 Percent

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from an initial proof-of-concept study of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, combined with standard treatments, one with bevacizumab and others without, in non-small cell lung cancer (NSCLC) including chemotherapy in previously untreated patients with NSCLC; the study showed overall response rates (ORR) ranging from 48 to 71 percent, depending on the therapy used. These data, from the phase 1/2 KEYNOTE-021 trial, will be presented today at the 52 nd Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Shirish Gadgeel of the Barbara Ann Karmanos Cancer Institute (Abstract #9016) from 8:00 – 11:30 a.m. CDT (Location: Hall A) and in a poster discussion from 3:00 – 4:15 p.m. CDT (Location: E354b). “Combining KEYTRUDA and chemotherapy in the first-line lung cancer treatment setting is an important part of our effort to develop more treatment options

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New KEYTRUDA® (pembrolizumab) Data at 2016 ASCO Annual Meeting Includes Three-Year Overall Survival Data in Melanoma and Updated Overall Survival Data in Non-Small Cell Lung Cancer As Well As Updated Findings in Head and Neck Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new and updated data investigating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in more than 15 types of cancer will be presented at the 52 nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, June 3 – 7, 2016. At this year’s meeting, researchers will present data from studies of KEYTRUDA as a single agent, and in combination with other therapies, in melanoma and non-small cell lung cancer (NSCLC), as well as bladder, colorectal, esophageal, gastric, head and neck, renal cancers, lymphoma and multiple myeloma. First-time presentation of findings for KEYTRUDA will be presented in new tumor types including cervical, endometrial, leiomyosarcoma, pancreatic, salivary, and thyroid. Several abstracts were chosen to be presented as oral presentations – one of which includes three-year survival data for patients with advanced melanoma (abstract #9503); this

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Merck Statement on Blueprint Project Findings Presented at the American Association for Cancer Research 2016 Annual Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, is proud to be a part of the Blueprint PD-L1 Assay Comparison Project, an important initiative to compare several new diagnostic tests for the immune biomarker PD-L1 in non-small cell lung cancer (NSCLC). Merck believes strongly in the importance of PD-L1 testing in NSCLC, and is committed to supporting the Blueprint Project and overall efforts to use diagnostics to help physicians identify the best treatment approach for their patients with some cancers. In oncology, testing is now common for numerous cancer biomarkers to enable physicians to better tailor treatment decisions for each patient. The data from a range of studies, including Merck’s studies of KEYTRUDA® (pembrolizumab), demonstrate that PD-L1 testing can be a useful tool to help identify patients more likely to respond to treatment with an anti-PD-1/PD-L1 therapy in certain cancers, including NSCLC. Phase 1 of the Blueprint Project is an important step

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Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA® (pembrolizumab) in Classical Hodgkin Lymphoma (cHL)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This is the fourth Breakthrough Therapy Designation granted for KEYTRUDA. “Merck has launched an ambitious clinical development program examining the efficacy of KEYTRUDA in a broad range of solid and blood cancers, and our studies of relapsed or refractory classical Hodgkin lymphoma are quite promising,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The FDA’s Breakthrough Designation for this blood cancer provides an important mechanism to assist us in bringing this immunotherapy to patients who could benefit from its use.” The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate

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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Recurrent or Metastatic Head and Neck Cancer, and Grants Priority Review

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of Aug. 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program. “Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president

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Merck to Present New Data for KEYTRUDA® (pembrolizumab) at the American Association for Cancer Research 2016 Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new research investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in multiple tumor types, both as a single agent and in combination with other therapies, will be presented at this year’s American Association for Cancer Research (AACR) Annual Meeting in New Orleans, April 16 – 20. “The data being presented at AACR reinforce our commitment to studying KEYTRUDA in a broad array of tumors and in a range of settings in order to fully understand its potential to improve long-term disease control and survival for people with cancer,” said Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. “As a leader in immuno-oncology, Merck continues to accelerate and further expand our clinical development program – with a goal to provide clinicians with data to understand the role of KEYTRUDA in a range of

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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, to include data from KEYNOTE-010. The trial was a pivotal Phase 2/3 study designed to evaluate KEYTRUDA compared to chemotherapy based on prospective measurement of PD-L1 expression in previously treated patients with advanced non-small cell lung cancer. KEYNOTE-010 was published in The Lancet in December 2015. “The data from KEYNOTE-010 demonstrated an overall survival benefit in patients with PD-L1 expression on one percent or more of the cancer cells,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to working with the FDA over the course of the application review process and remain committed to

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Merck Acquires IOmet Pharma and Expands Immuno-Oncology Development Program

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that it has acquired IOmet, a privately-held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. Under terms of the agreement, Merck, through a subsidiary, will acquire IOmet, including its comprehensive pre-clinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. Based on the transaction, IOmet will become a wholly owned subsidiary of Merck. “By harnessing the power of the immune system, we are already witnessing great advancements in the treatment of cancer,” said Eric Rubin, M.D., vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. “The acquisition of IOmet is a further example of Merck’s commitment to fully realizing the

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Merck’s KEYTRUDA® (pembrolizumab) Significantly Improves Survival Compared to Chemotherapy in Previously-Treated Patients with Non-Small Cell Lung Cancer Whose Tumors Express Any Level of PD-L1

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the pivotal KEYNOTE-010 study, the first study of its kind to evaluate the potential of an immunotherapy compared to chemotherapy based on prospective measurement of PD-L1 expression in patients with advanced non-small cell lung cancer (NSCLC). In the Phase 2/3 study, KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, significantly improved overall survival (OS) compared to chemotherapy in patients with any level of PD-L1 expression, as defined by a tumor proportion score (TPS) of 1 percent or more. The results were published in The Lancet and will be presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress. “Because lung cancer remains one of the most common and most challenging cancers to treat, understanding the role that KEYTRUDA can play in helping patients was essential to our development program. In this study in patients

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Responses Observed in Three-Quarters of Heavily Pre-Treated Multiple Myeloma Patients Receiving KEYTRUDA® (pembrolizumab) Combined With Lenalidomide and Dexamethasone

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today new study findings investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with lenalidomide and low-dose dexamethasone (two commonly used treatments for multiple myeloma) in patients whose disease has progressed after at least two lines of prior therapy, including a proteasome inhibitor and an IMiD (immune modulatory drug). The initial findings from the ongoing Phase 1 KEYNOTE-023 study showed an overall response rate (ORR) of 76 percent (n=13/17), as assessed by the International Myeloma Working Group (IMWG) 2006 Criteria. These results will be presented today at the 57 th American Society of Hematology (ASH) Annual Meeting by Jesus San Miguel, M.D., Ph.D., Clínica Universidad de Navarra, Pamplona, Spain (Abstract #505). Based in part on these data, Merck has initiated two Phase 3 studies evaluating KEYTRUDA in the treatment of multiple myeloma. “Many

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New Studies Investigating the Use of KEYTRUDA® (pembrolizumab) Across Solid and Hematological Cancers to Be Presented at Upcoming Congresses

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that data investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year. In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research (SMR) 2015 Congress in San Francisco, Nov. 18 – 21; the 57th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, Dec. 5 – 8; the San Antonio Breast Cancer Symposium (SABCS), Dec. 8 – 12; and the European Society for Medical Oncology (ESMO) Asia 2015 Congress in Singapore, Dec. 18 – 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types. “The field of immuno-oncology holds great potential across a broad spectrum

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Merck and DNAtrix Announce Phase 2 Immuno-Oncology Collaboration in Patients with Aggressive Form of Brain Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and DNAtrix today announced they have entered into an oncology clinical study collaboration to evaluate the efficacy and safety of DNX-2401, DNAtrix’s oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 2, multi-centered study of patients with recurrent glioblastoma, the most aggressive form of brain cancer for which there is no cure. DNX-2401 is a conditionally replicative oncolytic adenovirus designed to specifically target cells defective in the Retinoblastoma (Rb) pathway, which is present in many cancers. Several DNX-2401 clinical studies have demonstrated a favorable safety profile and strong tumor-killing potential in patients with recurrent glioblastoma. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. KEYTRUDA is currently approved in the United States

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Syndax and Merck Announce First Patients Dosed in Phase 1b/2 Clinical Trial of Entinostat and KEYTRUDA®

Clinical trial to assess safety and efficacy of immuno-oncology combination in patients with advanced NSCLC or melanoma WALTHAM, Mass. and KENILWORTH, N.J. – Syndax Pharmaceuticals, Inc. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the dosing of the first patients in the Phase 1b/2 clinical trial of Syndax’s entinostat in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) or melanoma. The clinical trial, designated ENCORE 601 by Syndax and KEYNOTE 142 by Merck, is evaluating the safety, tolerability and efficacy of entinostat, an oral, small molecule that targets immune regulatory cells, combined with KEYTRUDA, an anti-programmed cell death protein 1 (anti-PD-1) antibody.   “This is an important clinical milestone for Syndax and our collaboration with Merck that was achieved on schedule with our joint development plan,” said Michael L.

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New Data from KEYNOTE-028, Merck’s Trial Evaluating KEYTRUDA® (pembrolizumab) Across a Range of Cancer Types, Presented at 2015 European Cancer Congress

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new findings from the KEYNOTE-028 Phase 1b study, the clinical trial investigating the use of the company’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab) in multiple, difficult-to-treat cancers. Data from this trial, to be presented at the European Cancer Congress (ECC) in Vienna, Austria, Sept. 25-29, include the first-time findings for KEYTRUDA in two gastrointestinal cancers, advanced anal cancer and advanced biliary tract cancer, and add to Merck’s growing body of clinical data for KEYTRUDA. KEYNOTE-028 is an ongoing multi-cohort, non-randomized Phase 1b basket trial – a trial design that allows for the study of multiple sub-populations of different tumor or histological types within one study. The study is evaluating the safety, tolerability, and anti-tumor activity of KEYTRUDA monotherapy (10 mg/kg dosed every two weeks) in more than 450 patients across 20 different types of cancer. The study

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New Findings Show Anti-Tumor Activity of KEYTRUDA® (pembrolizumab) in Patients with Advanced Nasopharyngeal Carcinoma

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first-time presentation of findings investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy in patients with advanced unresectable nasopharyngeal carcinoma (NPC) – a type of head and neck cancer – whose tumors express PD-L1 (≥1% of cells in tumor nests or PD-L1+ bands in stroma). Data were from a Phase 1b study (KEYNOTE-028) and showed an overall response rate (ORR) (confirmed and unconfirmed) of 22.2 percent (95% CI, 8.6-42.3) in evaluable patients (n=27) who were treated with KEYTRUDA. Results were presented in an oral session by Dr. Chiun Hsu, National Taiwan University Hospital, at the European Cancer Congress (ECC) in Vienna (Abstract #2801). “Advanced nasopharyngeal carcinoma is a severe form of head and neck cancer often associated with a poor prognosis,” said Dr. Hsu. “These data presented at ECC represent the potential for new approaches to

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Data in Nine Difficult-to-Treat Cancers from Merck’s KEYTRUDA® (pembrolizumab) Development Program to be Presented at European Cancer Congress 2015, Including Data in Four New Cancer Types: ...

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that new data investigating the anti-tumor activity of KEYTRUDA ® (pembrolizumab) across a broad range of advanced cancers will be presented at this year’s European Cancer Congress (ECC) in Vienna, Austria, Sept. 25-29. In total, 15 KEYTRUDA-related abstracts across nine difficult-to-treat cancers will be presented at this year’s ECC – including four late-breaking oral presentations. First-time data looking at PD-L2 expression in multiple tumors to assess the potential value of this biomarker in patient responsiveness to anti PD-1 therapies will also be presented. With these and other presentations, data on the potential role of KEYTRUDA will have been presented in more than 17 different cancers. Studies accepted into this year’s ECC program also include the investigation of KEYTRUDA monotherapy in anal cancer, biliary tract cancer, colorectal cancer, Merkel cell carcinoma (a type of skin cancer),

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Merck Recalls TEMODAR® and Temozolomide Bottles with Cracked Caps Due to Failure to Meet Child–Resistant Closure Requirement

Merck (NYSE: MRK), known as MSD outside the United States and Canada, in conjunction with the U.S. Consumer Product Safety Commission (CPSC) today asked that all customers, including patients, inspect all bottles of TEMODAR® (temozolomide) capsules and all bottles of Temozolomide capsules (generic) for potential cracks in the child-resistant bottle caps. The medicine is manufactured by Merck and distributed in the United States by Merck as TEMODAR. The Temozolomide capsules (generic) are manufactured and packaged by Merck but sold and distributed by Sandoz, the authorized generic partner, under the Sandoz label. In addition to these supplies, Merck also provides TEMODAR in the United States in sachets (or pouches); TEMODAR in sachets are not affected. Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of TEMODAR and Temozolomide capsules (generic) could potentially have cracked caps. Those bottles could be at wholesalers,

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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, for First-Line Treatment of Advanced Melanoma, and Grants Priority Review

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy. Merck is seeking approval for KEYTRUDA, at the currently approved dose of 2 mg/kg every three weeks, for the first-line treatment of unresectable or metastatic melanoma patients. The FDA granted Priority Review with a PDUFA, or target action, date of December 19, 2015. Additionally, the FDA has extended the action date for a separate sBLA for KEYTRUDA for the treatment of patients with ipilimumab-refractory advanced melanoma. The new action date is now December 24, 2015. “Through our clinical program for KEYTRUDA we have accumulated substantial data on the role of our anti-PD-1 therapy in advanced melanoma. We look forward to the FDA's review of each of these applications, and to delivering on our goal of helping patients

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Merck and MD Anderson Cancer Center Announce Strategic Immuno-Oncology Research Collaboration in Solid Tumors

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and The University of Texas MD Anderson Cancer Center today announced that they have entered into a strategic clinical research collaboration to evaluate Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), in combination with other treatments, such as chemotherapy, radiation therapy and/or novel antitumor medicines. Under the terms of the agreement, collaborative studies will be conducted in the following tumor types: gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular carcinoma - over the three year period of the collaboration. The first studies are scheduled to start enrolling later this year. The agreement aims to define what combination modalities will work best with KEYTRUDA in these types of tumors by exploring promising new alternatives. The studies will be conducted in parallel, in order to determine optimal regimens in the most efficient manner possible. All studies will feature

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Merck Enhances Immuno-Oncology Portfolio with Acquisition of cCAM Biotherapeutics

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and cCAM Biotherapeutics announced today that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95 million in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510 million associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions. “We continue to strengthen our portfolio of immunotherapeutic candidates through strategic collaborations and acquisitions,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The acquisition of cCAM supports our objective to

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European Commission Approves Merck’s Anti-PD-1 Therapy, KEYTRUDA® (pembrolizumab), for Both First-line and Previously-treated Patients with Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the European Commission has approved KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults. The European Commission approval of KEYTRUDA is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. KEYTRUDA received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. Today’s approval allows marketing of KEYTRUDA in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. “Today’s European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world,” said

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Merck Announces Phase 3 Study of Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection Regimen Met Primary Endpoint in Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a Phase 3 study investigating the safety and efficacy of single-dose EMEND ® (fosaprepitant dimeglumine) for Injection, Merck’s substance P/neurokinin (NK-1) receptor antagonist, in combination with other anti-vomiting medicines, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic (vomit-inducing) chemotherapy (MEC). In the study, the first to evaluate an intravenous NK-1 receptor antagonist for the prevention of CINV associated with MEC, the single-dose EMEND for Injection regimen provided greater protection from nausea and vomiting following administration of chemotherapy versus an active control of placebo with other anti-vomiting medicines. These data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Annual Meeting

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FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Advanced Non-Small Cell Lung Cancer, and Grants Priority Review

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The FDA granted Priority Review with a PDUFA, or target action, date of October 2, 2015; the sBLA will be reviewed under the FDA’s Accelerated Approval program. “Today’s announcement reflects our commitment to accelerate the development of immunotherapeutic approaches to treat lung cancer, one of the most deadly malignancies,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “We believe that data submitted to the FDA illustrate the significant potential of KEYTRUDA

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Merck and Dynavax Announce New Collaboration Investigating the Combination of Immuno-Oncology Therapies

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Dynavax Technologies Corporation (Nasdaq: DVAX) today announced they have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from both companies’ pipelines: Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator, MK-1966, with Dynavax’s investigational toll-like receptor 9 (TLR9) agonist, SD-101. SD-101, KEYTRUDA, and MK-1966 are immunotherapies designed to enhance the body’s own defenses in fighting cancer. SD-101 is designed to mediate anti-tumor effects by triggering both innate and adaptive immune responses, including the induction of high levels of Type 1 interferon to stimulate recruitment of T-cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2.

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Findings Presented at 2015 ASCO Annual Meeting Add to Breadth of KEYTRUDA® (pembrolizumab) Data; Anti-Tumor Activity Now Demonstrated in 13 Different Tumor Types

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the first-time presentation of findings investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in multiple, difficult-to-treat cancers, including advanced small cell lung cancer (SCLC), esophageal cancer and ovarian cancer from the KEYNOTE-028 Phase 1b study. These data, which were presented at the 51 st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, May 29 – June 2, 2015, build upon Merck’s broad and fast-growing immuno-oncology clinical development program for KEYTRUDA. “The breadth and depth of the data being shared at ASCO reinforces the potential for the broad clinical activity that we have seen with KEYTRUDA in multiple types of cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. “Our goal is to help people with cancer and these data are furthering our

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TESARO and Merck to Collaborate on a Combination Study of Niraparib and KEYTRUDA® (pembrolizumab)

Clinical Trial Will Evaluate TESARO’s PARP Inhibitor with Merck’s Anti-PD-1 Therapy in Patients with Breast and Ovarian Cancers  WALTHAM, Mass., and KENILWORTH, N.J., May 30, 2015 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a collaboration  to evaluate the combination of TESARO’s niraparib plus Merck’s anti-PD1 therapy, KEYTRUDA® (pembrolizumab), in a Phase 1/2 clinical trial. This trial is planned to evaluate the preliminary safety and efficacy of niraparib plus KEYTRUDA in patients with triple negative breast cancer or ovarian cancer. This trial will be conducted by TESARO and Merck, through a subsidiary, and is expected to begin by the end of 2015. “The combination of a PARP inhibitor and anti-PD-1 antibody in this study has the potential to build upon the responses already observed with each of these compounds as monotherapies,” said Mary Lynne

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New Findings Show Durable Anti-Tumor Activity with KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Patients with Advanced Head and Neck Cancer, Regardless of PD-L1 Expression Status

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new investigational data evaluating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy from the KEYNOTE-012 Phase 1b study in 132 pre-treated patients with recurrent or metastatic head and neck cancer, regardless of PD-L1 expression status. In the evaluable patients, the overall response rate (ORR) (confirmed and unconfirmed) was 24.8 percent for KEYTRUDA (200 mg fixed dose every three weeks) (n=29/117) (95% CI, 17.3-33.6). When looking at HPV status, the ORR was similar among HPV-positive and HPV-negative disease (20.6 percent [n=7/34] and 27.2 percent [n=22/81], respectively) (95% CI, 8.7-37.9 and 17.9-38.2). These data, featured in the ASCO Press Program today, will be presented in an oral session by Dr. Tanguy Seiwert, The University of Chicago, on Monday, June 1 at the 51 st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (Abstract

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First Study Evaluating DNA Mismatch Repair as Genetic Guide for Immunotherapy Treatment with Merck’s KEYTRUDA® (pembrolizumab) Presented at 2015 ASCO Annual Meeting and Published in the New England Journal of Medicine

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the first study evaluating the correlation of benefit with an immunotherapy based on DNA mismatch repair (MMR) deficiency, a well-established form of genetic instability in many cancers characterized by the loss of function of the MMR pathway. The Phase 2 study, led by researchers from Johns Hopkins Kimmel Cancer Center, evaluated Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), in 48 evaluable, heavily pre-treated patients with advanced colorectal cancer and other solid tumors. In the colorectal cancer group with MMR-deficient tumors, an objective response rate (ORR) of 62 percent was observed (n=8/13). In contrast, no responses were observed in the colorectal cancer group with MMR-proficient tumors (n=0/25). At the time of analysis, the median progression-free survival (PFS) and overall survival (OS) were not reached in the MMR-deficient colorectal cancer group. These data,

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Amgen and Merck Announce Expansion of Collaboration to Support Studies of Talimogene Laherparepvec in Combination with KEYTRUDA® (pembrolizumab) in Patients with Head and Neck Cancer

Companies Also Plan to Initiate Phase 3 Trial in Combination for Advanced Melanoma  THOUSAND OAKS, Calif. and KENILWORTH, N.J., - May 29, 2015 – Amgen (NASDAQ: AMGN) and Merck (NYSE: MRK), known as MSD outside the U.S. and Canada, today announced an expanded collaboration to evaluate the efficacy and safety of talimogene laherparepvec, Amgen’s investigational oncolytic immunotherapy, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 1, open-label trial of  patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).  In addition, the companies announced that a global, randomized Phase 3 trial evaluating the combination in patients with regionally or distantly metastatic melanoma is being initiated. As previously announced, the compounds are being studied in a Phase 1, open-label trial in this patient population.  Both immunotherapies are designed to modulate the immune system. Talimogene

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Merck and NanoString Announce Clinical Research Collaboration to Develop an Immune-Related Gene Expression Assay for Use in the Development Program for KEYTRUDA® (pembrolizumab)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NanoString Technologies, Inc. (NASDAQ:NSTG) today announced a clinical research collaboration to develop an assay that will optimize immune-related gene expression signatures and evaluate the potential to predict benefit from Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), in multiple tumor types. The collaboration between NanoString Technologies, Inc., a provider of life science tools for translational research and molecular diagnostic products, and Merck, through a subsidiary, will utilize NanoString’s nCounter ® Analysis System to optimize gene expression signatures as part of the clinical development program for KEYTRUDA. “Our commitment to advancing the science of immuno-oncology includes pursuing cutting-edge RNA and DNA approaches to identify a range of biomarkers, such as immune-related gene expression signatures, that in addition to PD-L1 expression, may help to identify patients who may be more

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Merck Receives Positive CHMP Opinion for KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma, as both first-line therapy and in previously treated patients. The CHMP positive opinion for KEYTRUDA, which is based on data in more than 1,500 adult patients with advanced melanoma, will now be reviewed by the European Commission for central marketing authorization in the European Union (EU). “Merck is committed to bringing KEYTRUDA to people with advanced melanoma in Europe as rapidly as possible, and the positive CHMP opinion marks a significant step forward,” said Roger Dansey, therapeutic area head and senior vice president, oncology late stage development, Merck Research Laboratories. “We have established a

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2015 ASCO Annual Meeting: New Data in 10 Different Cancers from Merck’s Rapidly Expanding Immuno-Oncology Research Program for KEYTRUDA® (pembrolizumab) to be Presented

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new investigational data in 10 different types of cancer from the company’s immuno-oncology development program evaluating its anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab), will be presented at the 51 st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, May 29 – June 2, 2015. Merck is advancing a comprehensive clinical development program for KEYTRUDA, a fact reflected in the more than 40 abstracts accepted for this year’s ASCO meeting, including 11 oral presentations of which two are late-breakers (Abstract #LBA6008 and #LBA100) selected for the official ASCO press program on Friday, May 29. “At Merck, we are executing a broad and deep immuno-oncology research program – now in more than 85 studies and 30 different tumor types – to understand the potential for KEYTRUDA in a broad range of cancers, at different stages, lines of therapy, both alone and in combination,"

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Plexxikon and Merck to Collaborate on Combination Study Evaluating Investigational Immuno-oncology Regimen

Study will Evaluate Merck’s Anti-PD-1 Therapy, KEYTRUDA® (pembrolizumab), in Combination with Plexxikon’s PLX3397 BERKELEY, Calif., and KENILWORTH, N.J. – Plexxikon Inc., a member of Daiichi Sankyo Group, and Merck (NYSE:MRK), known as MSD outside the US and Canada, through a subsidiary, today announced a collaborative clinical trial that will evaluate the combination of PLX3397, Plexxikon’s investigational CSF-1R inhibitor, and KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, which provides the potential for a double blockade of cancer-induced immune suppression. The Phase 1/2 trial will enroll patients with advanced melanoma and multiple other solid tumors with the goal of determining the safety and tolerability of the combination therapy. The trial is expected to begin enrollment by mid-year. “We are excited to evaluate PLX3397 in combination with KEYTRUDA, as each agent is designed to attack cancer cells in different ways. Cancer cells use multiple tactics to evade host

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TetraLogic and Merck to Collaborate on the Evaluation of Birinapant in Combination with KEYTRUDA® (pembrolizumab) in Solid Tumors

TetraLogic Pharmaceuticals Corporation (Nasdaq: TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today they have entered into an oncology clinical study collaboration. The companies will collaborate on a Phase 1 study to evaluate the safety and efficacy of birinapant, TetraLogic’s SMAC-mimetic, in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with relapsed or refractory solid tumors. The study is expected to begin in late 2015. KEYTRUDA and birinapant target different elements of cancer’s block against the immune system. TetraLogic’s birinapant (TL32711) is a potent, bivalent SMAC-mimetic that binds with differential affinity to multiple members of the IAP family in order to re-establish the immune system’s ability to kill abnormal cells via an extracellular

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Early Findings with KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Patients with Advanced Pleural Mesothelioma Presented at AACR Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data investigating the use of KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in 25 patients with advanced pleural mesothelioma, a difficult-to-treat cancer of the lining of the lungs, abdomen and other organs. The early findings presented showed an overall response rate (confirmed and unconfirmed) of 28 percent with KEYTRUDA in patients with tumors that expressed PD-L1. Additionally, 48 percent of patients had stable disease, resulting in a disease control rate of 76 percent. These data, from KEYNOTE-028, will be presented today at the American Association for Cancer Research (AACR) Annual Meeting by Dr. Evan Alley, Abramson Cancer Center, University of Pennsylvania, and were part of the AACR official press program (abstract #CT103). This is the first data to be presented from KEYNOTE-028, Merck’s innovative basket trial designed to evaluate the efficacy and

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KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, Demonstrates Superior Survival, Progression Free Survival and Overall Response Rate Compared to Ipilimumab an Anti-CTLA-4 Therapy...

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from the randomized, pivotal Phase 3 study, KEYNOTE-006, in the treatment of unresectable advanced melanoma. In the study, KEYTRUDA ® (pembrolizumab) was statistically superior to ipilimumab for progression-free survival (PFS), overall survival (OS), and overall response rate (ORR). On March 24, 2015, Merck announced that KEYNOTE-006 would be stopped early based on these data ( link ). The results will be presented today at the American Association for Cancer Research (AACR) Annual Meeting by Dr. Antoni Ribas of Jonsson Comprehensive Cancer Center, University of California, Los Angeles (abstract # CT101), included in the AACR press program, and were also published today in the New England Journal of Medicine. “Improving survival is the ultimate objective in treating patients with cancer. In this important study in advanced melanoma, KEYTRUDA was statistically superior to ipilimumab for

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Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC) with KEYTRUDA® (pembrolizumab) Presented at AACR Annual Meeting and Published in the New England Journal of Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced new data from KEYNOTE-001, a Phase 1b study evaluating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in naïve and previously-treated patients with advanced non-small cell lung cancer (NSCLC). In an analysis of 313 patients from a validation data set for tumor PD-L1 expression, overall-response rate (ORR) was 45.2 percent 1 (95% CI, 33.5-57.3) in patients with greater than or equal to (≥) 50 percent of tumor cells positive for PD-L1 expression (n=73). In the other PD-L1 subgroups, ORR was 16.5 percent (95% CI, 9.9-25.1) in patients with 1-49 percent tumor cells positive (n=103) and 10.7 percent (95% CI, 2.3-28.2) in patients with less than 1 percent tumor cells positive (n=28) for PD-L1 expression. In the total study population, ORR was 19.4 percent (95% CI, 16.0-23.2) (n=495), which was consistent with data previously presented from this study. These data from KEYNOTE-001 will be

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Merck Announces Submission of Supplemental Biologics License Application (sBLA) to U.S. FDA for KEYTRUDA® (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of advanced non-small cell lung cancer (NSCLC). KEYTRUDA previously received Breakthrough Therapy designation for advanced NSCLC and this initial filing seeks approval in the treatment of patients with advanced NSCLC whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. Under PDUFA, the FDA has 60 days from submission of the sBLA to determine if the application will be accepted for review. The submission is based on data from KEYNOTE-001 in patients with greater than or equal to 50 percent of tumor cells positive for PD-L1 expression. These data will be presented later today at the American

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Advaxis and Merck Announce Initiation of Enrollment in the Phase 1/2 Study of ADXS-PSA in Combination with Anti-PD-1 Therapy, KEYTRUDA® (pembrolizumab), for the Treatment of Advanced Prostate Cancer

KEYNOTE-046 is the second trial initiated to evaluate KEYTRUDA, and the first-in-human study of ADXS-PSA, for prostate cancer Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA (ADXS31-142), an investigational Lm-LLO immunotherapy, and KEYTRUDA® (pembrolizumab), the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxis’s lead Lm-LLO immunotherapy candidate for prostate cancer.  It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.  ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known

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Syndax and Merck to Collaborate on Immuno-Oncology Study Evaluating Entinostat in Combination with KEYTRUDA® (pembrolizumab) in Lung Cancer and Melanoma

Syndax Pharmaceuticals, Inc., and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that they have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Syndax’s entinostat, an investigational epigenetic therapy, with Merck’s KEYTRUDA ® (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The Phase 1b/2 study will evaluate this novel combination regimen in patients with either advanced non-small cell lung cancer (NSCLC) or melanoma. The study is expected to begin enrolling patients in the second half of 2015. Entinostat is an oral, highly selective histone deacetylase (HDAC) inhibitor granted Breakthrough Therapy Designation in combination with hormone therapy in advanced hormone receptor positive (HR+) breast cancer and currently in Phase 3 testing in this indication. Entinostat has been shown in preclinical models to reduce the number and function of host immune suppressor cells thereby

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Merck’s Pivotal KEYNOTE-006 Study in First-Line Treatment for Advanced Melanoma Met Co-Primary Endpoints and Will be Stopped Early

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the randomized, pivotal Phase 3 study (KEYNOTE-006) investigating KEYTRUDA ® (pembrolizumab) compared to ipilimumab in the first-line treatment of patients with advanced melanoma has met its two primary endpoints of progression-free survival and overall survival. The trial will be stopped early based on the recommendation of the study’s independent Data Monitoring Committee. In KEYNOTE-006, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival compared to ipilimumab. The safety profile of KEYTRUDA in this trial was similar to the safety profile previously reported in advanced melanoma. KEYTRUDA is the first anti-PD-1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma. These data will be presented in the opening plenary session at the

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New Data Investigating Merck’s KEYTRUDA® (pembrolizumab) in Advanced Non-Small Cell Lung Cancer and Mesothelioma to Be Presented in Clinical Trials Plenary Session at AACR 2015

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data evaluating KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, in both advanced non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma will be presented as part of the Clinical Trials Plenary Session on Sunday, April 19 at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia, April 18 – 22. The NSCLC data will be the first presentation of new efficacy and safety findings for KEYTRUDA from 495 patients, including validation of PD-L1 expression (abstract #CT104). These data are from the largest, multi-center Phase 1b (KEYNOTE-001) study of an anti-PD-1 therapy. With the mesothelioma findings (abstract #CT103), data evaluating KEYTRUDA will have been presented in eight different types of cancer. “Our clinical program is investigating the potential of KEYTRUDA in a broad range of cancers where innovative approaches are truly needed –

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KEYTRUDA® (pembrolizumab) is First Medicine to be Made Available to Patients Through U.K. Early Access to Medicines Scheme (EAMS) for Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company’s anti-PD-1 therapy, pembrolizumab, which is marketed in the U.S. under the name KEYTRUDA ® , is the first treatment to be accepted under the U.K.’s new Early Access to Medicines Scheme (EAMS). Pembrolizumab was accepted under the scheme for the treatment of advanced melanoma based on the significance of the early study findings and unmet medical need. Pembrolizumab received the Promising Innovative Medicine (PIM) designation in the U.K., on Oct. 10, 2014. In 2014, the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) introduced the EAMS to help patients benefit from promising, innovative treatments before a European license has been granted. The European Marketing Authorization for pembrolizumab for the treatment of advanced melanoma is currently under review. “Merck has charted a path to accelerate the development of pembrolizumab, and is collaborating with governments

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Eisai and Merck Enter Collaboration to Explore Novel Combination Regimens of Anti-PD-1 Therapy with Multi-targeting RTK Inhibitor and Microtubule Dynamics Inhibitor in Multiple Types of Cancer

Eisai Co., Ltd. and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, through a subsidiary, announced today a clinical trial collaboration to evaluate the safety, tolerability and efficacy of Merck’s anti-PD-1 therapy, pembrolizumab (marketed in the U.S. under the brand name KEYTRUDA ® ), in combination with Eisai oncology compounds lenvatinib mesylate (a multi-targeting RTK inhibitor marketed in the U.S. under the brand name LENVIMA™, “lenvatinib”) and eribulin mesylate (a microtubule dynamics inhibitor marketed in nearly 60 countries including Japan, the U.S., and Europe under the brand name HALAVEN ® , “eribulin”) in multiple clinical trials. The planned studies include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in select solid tumors and an open-label, single-arm, multicenter Phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer. Eisai and Merck will

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Lilly, Merck Enter Collaboration Agreement to Research Immuno-Oncology Combination Regimens in Multiple Types of Cancer

Merck (NYSE:MRK), known as MSD outside the US and Canada, and Eli Lilly and Company (NYSE:LLY) announced today an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials: Merck will conduct a Phase 2 study examining the combination of pembrolizumab with pemetrexed in first-line non-squamous, non-small cell lung cancer (NSCLC). This study is currently enrolling. Lilly will conduct a multiple-arm Phase 1/2 study examining the combination of ramucirumab with pembrolizumab in multiple tumors. This study is anticipated to begin in 2015. Lilly will conduct a Phase 1/2 study examining the combination of necitumumab with pembrolizumab in NSCLC. This study is anticipated to begin in 2015. The agreement is between Lilly and Merck, through a subsidiary. Additional details of the collaboration were not disclosed. “Cancer is not one disease but

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International Breast Cancer Study Group, Breast International Group and Merck Announce Opening of International PANACEA Study of Patients with HER2+ Breast Cancer

The International Breast Cancer Study Group (IBCSG), Breast International Group (BIG), and Merck, known as MSD outside the United States and Canada, today announced the opening of the PANACEA study, a global collaborative study exploring a new way to treat HER2+ breast cancer that has become resistant to the current standard of care. The PANACEA study will investigate the use of pembrolizumab (KEYTRUDA ® ) in combination with trastuzumab to evaluate whether the addition of an anti-PD-1 therapy can reverse trastuzumab resistance in patients with HER2+ breast cancer whose cancer has spread while on trastuzumab therapy. Worldwide, breast cancer is the most common cancer among women.1 About one in five patients with breast cancer have too much of a growth-promoting protein known as HER2/neu (or just HER2) on the surface of cancer cells. Breast cancers with too much of this protein tend to grow and spread more aggressively. “PANACEA is the first phase 2 immunotherapy trial not only in

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Data Investigating KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Patients with Advanced Triple-Negative Breast Cancer Presented at 2014 San Antonio Breast Cancer Symposium

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today early study findings demonstrating an overall response rate of 18.5 percent with KEYTRUDA, the company’s anti-PD-1 therapy, as assessed by RECIST v1.1, central review (n=5/27), in PD-L1 positive, advanced triple-negative breast cancer – one of the most aggressive forms of breast cancer. At the time of analysis, the median duration of response had not been reached with three of five responders on therapy for 11 months or more (range, 15 to 40+ weeks). These early findings, from the ongoing Phase 1b KEYNOTE-012 study, were shared today for the first time as part of the official press program at the 2014 San Antonio Breast Cancer Symposium (SABCS) (ABSTRACT #S1-09) and will be presented in an oral session at 10:45 a.m. CST by Dr. Rita Nanda, the University of Chicago. “Metastatic, triple-negative breast cancer is an aggressive and often difficult to treat disease,” said Dr. Rita Nanda, associate

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Data Investigating KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Patients with Classical Hodgkin Lymphoma Presented at ASH Annual Meeting

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today early study findings demonstrating that KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, achieved an overall response rate of 66 percent, as assessed by International Harmonization Project response criteria (n=19/29: 95% CI, 46-82), in transplant-ineligible and failure patients with relapsed/refractory classical Hodgkin Lymphoma (cHL) whose disease progressed on or after treatment with brentuximab vedotin. Complete remission was achieved in 21 percent of patients (n=6/29) in the study. At the time of analysis, 89 percent of responses were ongoing (n=17/19) with the median duration of response not yet reached (range 1+ to 185+ days). These early findings, from the ongoing Phase 1b KEYNOTE-013 study, were described for the first time as part of the official press program at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco (ABSTRACT #290) and will be presented in

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Merck Announces Positive Study Investigating the Use of KEYTRUDA® (pembrolizumab) Compared to Chemotherapy in Patients with Ipilimumab-Refractory Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that a pre-specified analysis of investigational data from a pivotal Phase 2 study (KEYNOTE-002) showed KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, substantially improved the primary endpoint of progression-free survival (PFS, as assessed by RECIST 1.1, independent central review) (HR 0.57 and 0.50 for 2 mg/kg and 10 mg/kg every three week doses, respectively), compared to chemotherapy (P<0.0001 for both comparisons) in patients with ipilimumab-refractory advanced melanoma (n=540). At six months, the PFS rates for KEYTRUDA were 34 percent at the 2 mg/kg dose (95% CI, 27-41) (n=180) and 38 percent at the 10 mg/kg dose (95% CI, 31-45) (n=181), compared to 16 percent for chemotherapy (95% CI, 10-22) (n=179). The median duration of follow-up at the interim analysis was 10 months. These findings, including pre-specified analyses of overall response rate (ORR), duration of response,

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New Studies Investigating the Use of KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Advanced Melanoma Compared to Chemotherapy, in Classical Hodgkin Lymphoma and in Triple Negative Breast Cancer, to be Presented for the First Time

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that in November and December, data will be presented for the first time investigating the use of KEYTRUDA ® (pembrolizumab) – the company’s anti-PD-1 therapy – in advanced melanoma in comparison to chemotherapy, and in relapsed/refractory classical Hodgkin Lymphoma (cHL) as well as advanced triple negative breast cancer (TNBC). These studies will be presented in oral sessions at the Society for Melanoma Research (SMR) 2014 International Congress, Nov. 13 – 16, the 56th American Society of Hematology (ASH) Annual Meeting, Dec. 6 – 9, and the San Antonio Breast Cancer Symposium (SABCS), Dec. 9 – 13, respectively. By the end of 2014, data on anti-tumor activity of KEYTRUDA as monotherapy will have been presented in seven different tumor types. “Our focus on evaluating KEYTRUDA as a monotherapy is enabling Merck to rapidly advance the clinical development of our anti-PD-1 therapy,” said Dr. Roy Baynes,

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Merck Receives FDA Breakthrough Therapy Designation for KEYTRUDA® (pembrolizumab) in Advanced Non-Small Cell Lung Cancer

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA ® (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with Epidermal Growth Factor Receptor (EGFR) mutation-negative, and Anaplastic Lymphoma Kinase (ALK) rearrangement-negative non-small cell lung cancer (NSCLC) whose disease has progressed on or following platinum-based chemotherapy. This is the second Breakthrough Therapy Designation granted for KEYTRUDA. “The FDA’s Breakthrough Therapy Designation of KEYTRUDA underscores that new treatment approaches for advanced non-small cell lung cancer continue to be needed,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “Our data investigating the use of KEYTRUDA in this difficult-to-treat malignancy are very encouraging, and we look forward to working closely with the FDA to expedite our clinical program.”

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Merck Announces First Presentation of Early Data on the Investigational Use of KEYTRUDA® (pembrolizumab) in Patients with Advanced Bladder Cancer at ESMO 2014

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data on the investigational use of KEYTRUDA ® (pembrolizumab) – the company’s anti-PD-1 therapy – in PD-L1 positive, advanced urothelial cancer (also known as bladder cancer). The early findings presented showed a confirmed overall response rate of 24 percent with KEYTRUDA as monotherapy, as measured by RECIST v1.1, central review (n= 7/29: 95% CI, 10.3-43.5) including a complete response rate of 10 percent (3/29). At the time of analysis, response durations ranged from 16+ to 40+ weeks with six of the seven responders continuing on therapy. In the ongoing study, 64 percent (61/95) of patients screened had tumors that were determined to be positive for PD-L1 expression. These data, from a cohort of the ongoing Phase 1b KEYNOTE-012 study, were presented today, as part of a late-breaking oral session, by Dr. Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, at the

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Merck Announces First Presentation of Data on the Investigational Use of KEYTRUDA® (pembrolizumab) in Patients with Advanced Gastric Cancer at ESMO 2014

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data on the investigational use of KEYTRUDA ® (pembrolizumab) – the company’s anti-PD-1 therapy – in PD-L1 positive, advanced gastric cancer. The early findings presented showed an overall response rate (confirmed and unconfirmed) of 31 percent with KEYTRUDA as monotherapy, as measured by investigator assessed, RECIST v1.1 (n= 12/39: 95% CI, 17-47). Similar overall response rates were observed in Asian patients (a population with a high incidence of gastric cancer) and non-Asian patients. At the time of analysis, response durations ranged from 8+ to 20+ weeks with 11 of 12 responders continuing on therapy. These data, from a cohort of the ongoing Phase 1b KEYNOTE-012 study, were presented today, as part of a late-breaking oral session, by Dr. Kei Muro, Aichi Cancer Center Hospital, Nagoya, Japan, at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid,

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Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab, the Company’s Investigational Anti-PD-1 Antibody, at ESMO 2014

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from ongoing clinical trials evaluating the anti-tumor activity of pembrolizumab, the company’s investigational anti-PD-1 antibody, at the European Society of Medical Oncology (ESMO) 2014 in Madrid, Spain, September 26 – 30. Data on pembrolizumab are planned to be presented in five advanced solid tumor types, including the first presentation of data evaluating pembrolizumab for the treatment of gastric and bladder (urothelial tract) cancers. Three late-breaking abstracts have been accepted for oral presentation. “We are pleased to present the first data for our investigational anti-PD-1 antibody pembrolizumab in gastric and bladder cancers at ESMO 2014,” said Dr. Roy Baynes, senior vice president, Global Clinical Development, Merck Research Laboratories. “The presentation of data for five advanced tumor types underscores the breadth of Merck’s immuno-oncology development

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Pfizer and Merck to Collaborate on Study Evaluating Novel Anti-Cancer Combination Regimen

Agreement to Combine Merck’s Investigational Anti-PD-1 Antibody Pembrolizumab and Pfizer’s crizotinib (XALKORI®) in Clinical Trial WHITEHOUSE STATION, N.J. – Pfizer Inc. (NYSE:PFE) and Merck & Co. Inc. (NYSE: MRK), known as MSD outside the United States and Canada, through a subsidiary, announced today that they have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI®) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC). The financial terms of the agreement were not disclosed.  “This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers,” said Dr. Mace Rothenberg, senior vice president of

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Merck Announces Data from Investigational Phase 3 Study on EMEND® (aprepitant) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children Undergoing Emetogenic Chemotherapy

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced results from a global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND ® (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years. In this study in pediatric cancer patients undergoing very highly, highly, or moderately emetogenic (vomit-inducing) chemotherapy, the use of the EMEND regimen for CINV prevention was significantly more effective than a control regimen in achieving Complete Response, defined as no vomiting or retching and no use of rescue medication for nausea and vomiting, in all phases of CINV (acute, delayed, and overall). These new data were presented in an oral session at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Annual International Symposium on Supportive Care in Cancer (Abstract #0286) by Dr. Hyoung Jin

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Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for the Treatment of Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for pembrolizumab (MK-3475), the company’s investigational anti-PD-1 antibody, for the treatment of advanced melanoma. If approved by the European Commission (EC), pembrolizumab has the potential to be the first anti-PD-1 therapy in Europe. Additional regulatory filings in other countries outside of Europe are planned by the end of 2014. “With the five-year survival rate for patients with advanced melanoma at less than 20 percent, there remains a need to offer patients additional options,” said Dr. Roy Baynes, senior vice president, clinical development, Merck Research Laboratories. “We are pleased to have regulatory applications under review in the United States and Europe as we work toward bringing pembrolizumab to patients around the world.” About Advanced Melanoma Melanoma is the most serious

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Data on Merck’s Pembrolizumab from Largest Study to Date of Investigational Anti-PD-1 Antibody in Advanced Melanoma Highlighted at ASCO 2014

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced new data from the company’s large ongoing Phase 1b study (KEYNOTE-001) evaluating pembrolizumab (MK-3475), Merck’s investigational anti-PD-1 antibody, as a single agent (monotherapy) in 411 patients with advanced melanoma. Following treatment with pembrolizumab, the estimated overall survival (OS) rate at one year was 69 percent across all patients studied, including 74 percent in patients without prior ipilimumab therapy (current standard therapy) and 65 percent in patients who had progressive disease on or following ipilimumab. At 18 months, the estimated OS was 62 percent. The median OS has not been reached, with some patients receiving treatment with pembrolizumab as monotherapy for more than two years. These new data will be presented today in an oral session by Dr. Antoni Ribas, professor, Hematology/Oncology and Surgery, and director of the Tumor Immunology Program at the Jonsson Comprehensive

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First Presentation of Data for Pembrolizumab, Merck’s Investigational Anti-PD-1 Antibody, in Patients with Previously-Untreated, Advanced Non-Small Cell Lung Cancer (NSCLC) at ASCO 2014

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of data evaluating pembrolizumab (MK-3475), Merck’s investigational anti-PD-1 antibody, as initial therapy in patients with PD-L1 positive, advanced non-small cell lung cancer (NSCLC). In previously-untreated patients, the objective response rate (ORR) (confirmed and unconfirmed) with pembrolizumab as a single-agent (monotherapy) was 47 percent by investigator-assessed, immune-related response criteria (irRC) (n=21/45: 95% CI, 32-62) and 26 percent by centrally evaluated RECIST v1.1 (Response Evaluation Criteria in Solid Tumors) (n=11/42: 95% CI, 14-42). In evaluable patients who had measurable disease with one post baseline scan, 80 percent demonstrated tumor shrinkage as measured by centrally evaluated RECIST criteria (n=28/35). The median duration of response has not been reached, with some patients continuing on treatment with pembrolizumab as monotherapy for at least one

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First Presentation of Early Data for Pembrolizumab (MK-3475), Merck’s Investigational Anti-PD-1 Antibody, in Advanced Head and Neck Cancer at ASCO 2014

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the first presentation of early findings from a Phase 1b study (KEYNOTE-012) evaluating pembrolizumab (MK-3475), Merck’s investigational anti-PD-1 antibody, as a single-agent (monotherapy) in patients with PD-L1 positive, advanced head and neck cancer. Early data showed a best overall response rate of 20 percent (confirmed and unconfirmed) (n=11/56) (95% CI, 10.2- 32.4) with 29 percent of patients having stable disease as measured by RECIST criteria (n=16/56) (95% CI, 17.3-42.2). Similar overall response rates were observed in Human papillomavirus (HPV)-positive and HPV-negative patients – HPV infection is a risk factor for some types of head and neck cancer. In the study, tumor shrinkage was demonstrated in 51 percent of evaluable patients who had measurable disease with one post baseline scan, per RECIST criteria (n=26/51). These early findings will be presented today in an oral session by Dr.

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Merck and Endocyte Announce Withdrawal of Conditional Marketing Authorization Applications for Vintafolide and Companion Imaging Components, Etarfolatide and Intravenous (IV) Folic Acid in Europe

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Endocyte, Inc. (NASDAQ:ECYT), today announced the withdrawal of conditional marketing authorization applications (CMA) from the European Medicines Agency (EMA) for vintafolide and companion imaging components, imaging agent etarfolatide and intravenous (IV) folic acid, for the treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD). The Companies’ decision was based on further review of interim data from the PROCEED trial. Study enrollment was suspended earlier this month based on the Data Safety Monitoring Board’s (DSMB) recommendation that the study be stopped because vintafolide in combination with PLD versus PLD alone did not meet the pre-specified criteria for progression-free survival to allow continuation of the study. The DSMB did not identify any safety concerns for the patients enrolled in the PROCEED trial.

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Merck’s Investigational Anti-PD1 Antibody, MK-3475, Active in Three Different Tumor Types: New Data to be Presented at the 2014 ASCO Annual Meeting

Six oral presentations report MK-3475 monotherapy data across three different tumor types and multiple lines of therapy Late-breaker presentation of long-term findings of MK-3475 in advanced melanoma, including ipilimumab-naïve and treated settings; data included in ASCO Press Program First presentation of findings evaluating MK-3475 as initial treatment of patients with advanced non-small cell lung cancer First presentation of findings of MK-3475 in recurrent/metastatic head and neck cancer Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that new data for the company’s investigational anti-PD-1 antibody, MK-3475, in advanced melanoma, non-small cell lung cancer (NSCLC), and head and neck cancer, are scheduled to be presented at the 50 th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago on May 30 – June 3, 2014. The first presentation of data for MK-3475 as initial treatment in advanced NSCLC (Abstract #8007) – where

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Merck Announces FDA Acceptance for Review of MK-3475 Biologics License Application for Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MK-3475, Merck’s investigational anti-PD-1 antibody, for the treatment of unresectable or metastatic melanoma in patients who have been previously treated with ipilimumab. The FDA granted Priority Review designation with a PDUFA date of October 28, 2014, and the MK-3475 BLA will be reviewed under the FDA’s Accelerated Approval program. The FDA previously granted MK-3475 Breakthrough Therapy designation for advanced melanoma, the most dangerous type of skin cancer. If approved by the FDA, MK-3475 has the potential to be the first anti-PD-1 antibody in a new class of immune checkpoint modulators. Merck also announced it plans to file a Marketing Authorization Application for MK-3475 in Europe for advanced melanoma by the end of 2014. “Patients with advanced melanoma have few therapeutic

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Merck and Endocyte Announce Independent DSMB Recommends Vintafolide PROCEED Phase 3 Trial Be Stopped for Futility Following Interim Analysis

Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Endocyte, Inc. (NASDAQ:ECYT), today announced that the Data Safety Monitoring Board (DSMB) of the PROCEED trial has completed a pre-specified, interim futility analysis and the DSMB recommended that the trial be stopped because vintafolide did not demonstrate efficacy on the pre-specified outcome of Progression-Free Survival (PFS) in patients with platinum-resistant ovarian cancer. The DSMB did not identify any safety concerns for the patients enrolled in the trial. Based on the DSMB recommendation and while further review of the data is conducted, the Companies have taken steps to notify investigators that screening and randomization of participants in the trial will be suspended. PROCEED is a Phase 3 randomized, double-blind clinical trial, evaluating vintafolide in combination with pegylated liposomal doxorubicin (PLD) compared to PLD plus placebo for the treatment of folate receptor-positive,

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Early Findings Exploring the Relationship of PD-L1 Expression and Clinical Outcomes with MK-3475, Merck’s Investigational Anti-PD-1 Immunotherapy, Presented at AACR Annual Meeting 2014

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of early findings from studies exploring the relationship between tumor PD-L1 expression and clinical outcomes following monotherapy treatment with MK-3475, an investigational anti-PD-1 immunotherapy, in patients with advanced melanoma and advanced non-small cell lung cancer (NSCLC). Responses were observed in patients with PD-L1 negative tumors; although the preliminary findings for both tumor types suggest that higher PD-L1 expression was associated with higher overall response rates. Further study of the relationship between PD-L1 expression and responses to MK-3475 as monotherapy and in combination with other treatments for melanoma, NSCLC and other tumors is ongoing or planned. These findings will be presented today in an oral session at the AACR Annual Meeting 2014 in San Diego and were highlighted within the official AACR press program. Separately, as part of today’s opening

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Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT® (vintafolide) and Companion Imaging Agents FOLCEPRI® (etarfolatide) and NEOCEPRI® (Intravenous (IV) folic acid) in Patients with Platinum-Resistant ...

Merck and Endocyte Announce European CHMP Positive Opinions for VYNFINIT ® (vintafolide) and Companion Imaging Agents FOLCEPRI ® (etarfolatide) and NEOCEPRI ® (Intravenous (IV) folic acid) in Patients with Platinum-Resistant Ovarian Cancer WHITEHOUSE STATION, N.J. & WEST LAFAYETTE, Ind.-(BUSINESS WIRE)- Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Endocyte, Inc. (NASDAQ:ECYT), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions for the Conditional Marketing Authorisations of VYNFINIT® (vintafolide) and companion imaging components, imaging agent FOLCEPRI® (etarfolatide), and NEOCEPRI® (intravenous (IV) folic acid), for the treatment of adult patients with folate receptor-positive, platinum-resistant, ovarian cancer, in combination with pegylated liposomal doxorubicin (PLD). “These positive CHMP opinions bring Merck and Endocyte one step closer to providing a

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Merck Enters Strategic Collaborations with Amgen, Incyte and Pfizer to Evaluate Novel Combination Anti-cancer Regimens with MK-3475

Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen Inc., Incyte Corporation and Pfizer Inc. to evaluate novel combination regimens with MK-3475, Merck’s investigational anti-PD-1 immunotherapy. The financial terms of the agreements were not disclosed. “Merck clinical scientists intend to explore the potential of our PD-1 inhibitor across a wide range of cancers, both as monotherapy and in combination,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “These new collaborations with Amgen, Incyte and Pfizer underscore our shared determination to evaluate treatment regimens with the potential to provide meaningful benefits to patients suffering from cancer.” Planned investigations include: Pfizer and Merck will evaluate in Phase I/II clinical studies the safety and efficacy of MK-3475 in combination with Pfizer’s small molecule kinase

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Merck Initiates Rolling Submission of U.S. Biologics License Application for MK-3475, an Investigational Anti-PD-1 Immunotherapy, in Patients with Advanced Melanoma

Merck (NYSE:MRK), known as MSD outside the United States and Canada, said today it has started a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application for MK-3475, the company’s investigational anti-PD-1 immunotherapy, for patients with advanced melanoma who have been previously treated with ipilimumab. A rolling submission allows completed portions of the application to be submitted and reviewed by the FDA on an ongoing basis. The company expects to complete the application in the first half of 2014. “Our MK-3475 is a novel immunomodulatory molecule that holds promise for patients with advanced malignancy who now have limited treatment options,” said Roger M. Perlmutter, M.D., Ph.D., president, Merck Research Laboratories. “Initiation of this rolling submission represents an important milestone in the MK-3475 clinical development program for patients suffering from malignant melanoma.” Clinical Development of MK-3475 in Advanced Melanoma