29 Results Found

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

Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Chemotherapy in Certain Patients with Metastatic Triple-Negative Breast Cancer

Data from Pivotal Phase 3 Trial Showed KEYTRUDA Plus Chemotherapy Reduced the Risk of Disease Progression or Death by 35% Compared to Chemotherapy Alone as First-Line Treatment in Patients with Metastatic TNBC Whose Tumors Expressed PD-L1 (CPS ≥10) Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive results from the Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (mTNBC). In patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) ≥10, KEYTRUDA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 35% (HR = 0.65 [95% CI, 0.49-0.86], p=0.0012) and improving PFS to a median of 9.7 months compared to 5.6 months for those receiving chemotherapy alone. In

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

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

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

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

Merck To Present New Data From Its Broad Oncology Portfolio and Pipeline at ESMO 2021, Including in Earlier Stages of Cancer

Pivotal Phase 3 Data for KEYTRUDA® (pembrolizumab) in Stage II Melanoma (KEYNOTE-716) and Recurrent, Persistent or Metastatic Cervical Cancer (KEYNOTE-826) Selected for ESMO Presidential Symposium Sessions and Official Press Program New Data for KEYTRUDA Demonstrate Significant Progress in Breast and Gynecological Cancer Clinical Programs Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that data spanning 20 types of cancer from its leading oncology research program will be presented at the European Society for Medical Oncology (ESMO) Congress 2021 from Sept. 16–21. Key data include new Phase 3 results for the company’s oncology medicines, specifically: KEYTRUDA, Merck’s anti-PD-1 therapy in melanoma (KEYNOTE-716) and recurrent, persistent or metastatic cervical cancer (KEYNOTE-826), which were selected for inclusion in the ESMO Presidential Symposium sessions and the ESMO Press Program, and in metastatic triple-negative breast cancer (TNBC)

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

Seattle Genetics and Merck Announce Two Strategic Oncology Collaborations

Companies to Co-Develop and Co-Commercialize Seattle Genetics’ Antibody-Drug Conjugate Ladiratuzumab Vedotin Globally; Merck to Acquire $1 Billion Equity Stake in Seattle Genetics Common Stock Companies Enter Exclusive License and Co-Development Agreement to Accelerate Global Reach of TUKYSA for HER2-Positive Cancers in Regions Outside the United States, Canada and Europe Seattle Genetics to Host Conference Call Today at 9:00 a.m. ET BOTHELL, Wash. and KENILWORTH, N.J. – September 14, 2020 – Seattle Genetics, Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced two new strategic oncology collaborations. The companies will globally develop and commercialize Seattle Genetics’ ladiratuzumab vedotin, an investigational antibody-drug conjugate (ADC) targeting LIV-1, which is currently in phase 2 clinical trials for breast cancer and other solid tumors. The collaboration will pursue a broad joint development program evaluating

KEYTRUDA® (pembrolizumab) Plus Chemotherapy Before Surgery and Continued as a Single Agent After Surgery Showed Statistically Significant Event-Free Survival (EFS) Result Versus Neoadjuvant Chemotherapy Alone in High-Risk Early-Stage TNBC

KEYNOTE-522 Is the First Phase 3 Study With an Immunotherapy to Show Positive EFS Results in High-Risk Early-Stage Triple-Negative Breast Cancer Merck Has Submitted These Data From KEYNOTE-522 to the US FDA for Review Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase 3 study KEYNOTE-522. The trial investigated neoadjuvant KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy followed by adjuvant KEYTRUDA as monotherapy (the KEYTRUDA regimen) compared with neoadjuvant chemotherapy followed by adjuvant placebo (the chemotherapy-placebo regimen) in patients with high-risk early-stage triple-negative breast cancer (TNBC). This is the first time an anti-PD-1/L1 therapy has demonstrated a statistically significant EFS result as combined neoadjuvant and adjuvant therapy for these patients. These results are being presented today during a European Society for Medical

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