New approval in Japan for KEYTRUDA regimen in the perioperative setting for certain patients with NSCLC based on results from KEYNOTE-671 Approval in Japan also demonstrates KEYTRUDA’s important role in combination with other therapies and as monotherapy in certain patients with urothelial carcinoma, based on results from KEYNOTE-A39 and KEYNOTE-052, respectively Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved new indications for KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in certain lung and urothelial cancers: KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment, for patients with non-small cell lung carcinoma (NSCLC) based on results from the Phase 3 KEYNOTE-671 trial; KEYTRUDA in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with radically
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Positive opinion granted for KEYTRUDA plus chemotherapy for the first-line treatment of adult patients with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy, based on the Phase 3 NRG-GY018 trial, also known as KEYNOTE-868 Positive opinion also granted for KEYTRUDA plus chemoradiotherap y for the treatment of FIGO 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy, based on the Phase 3 KEYNOTE-A18 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, for two indications in gynecologic cancers. The first opinion recommends the approval of KEYTRUDA in combination with carboplatin and paclitaxel, followed by KEYTRUDA as a single agent, for the first-line
Approval based on results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone Approval marks the first indication for KEYTRUDA in MPM in the U.S. Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). The approval is based on data from the pivotal Phase 2/3 IND.227/KEYNOTE-483 trial. In IND.227/KEYNOTE-483, KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; p=0.0162) compared to chemotherapy alone at the trial’s pre-specified final
Late-breaking results selected for presentation during a Presidential Symposium session and an official Press Briefing at the European Society for Medical Oncology Congress 2024 and simultaneous publication in the New England Journal of Medicine KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival as pre-operative (neoadjuvant) treatment with chemotherapy and then as a single agent after surgery (adjuvant) compared to pre-operative chemotherapy in patients with high-risk early-stage TNBC KEYNOTE-522 marks the fourth study of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an OS benefit Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first-time presentation of overall survival (OS) results from the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy
At 10 years, more than one-third (34.0%) of patients with advanced melanoma were alive after treatment with KEYTRUDA, compared to 23.6% of patients treated with ipilimumab Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with advanced melanoma. Based on 10 years of follow-up, the data showed sustained improved survival outcomes for patients receiving KEYTRUDA as a single agent compared to ipilimumab in patients with advanced melanoma. These late-breaking data will be presented for the first time today during a mini oral session at the European Society for Medical Oncology (ESMO) Congress 2024 (presentation #LBA44) and published in the Annals of Oncology . For patients with advanced melanoma, these long-term follow-up data showed the 10-year OS rate for KEYTRUDA was 34.0% versus 23.6% for
In the Phase 3 LEAP-012 trial, KEYTRUDA plus LENVIMA in combination with TACE reduced the risk of disease progression or death by 34% compared to TACE alone Late-breaking first interim analysis results are being presented during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced results from the first interim analysis of the Phase 3 LEAP-012 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA ® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) compared to TACE alone for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC). These late-breaking data are being presented for the first time today during a Presidential Symposium at the European Society for Medical
KEYNOTE-A18 is the first Phase 3 study of an immunotherapy in combination with CRT to demonstrate a statistically significant and clinically meaningful improvement in overall survival versus CRT alone in these patients Results were selected for the official press briefing and presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2024 and published simultaneously in The Lancet Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of overall survival (OS) results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with concurrent chemoradiotherapy (CRT) for newly diagnosed patients with high-risk (stage IB2-IIB with lymph node-positive disease and stage III-IVA with and without lymph node-positive disease) locally advanced cervical cancer. At a median follow-up of 29.9
KEYTRUDA is the first anti-PD-1/L1 therapy in combination with trastuzumab and chemotherapy to demonstrate a statistically significant improvement in OS in this patient population Results from the final analysis of KEYNOTE-811 are being presented during a Proffered Paper Session at the European Society for Medical Oncology (ESMO) Congress 2024 and published simultaneously in the New England Journal of Medicine In the U.S., KEYTRUDA, in combination with trastuzumab and chemotherapy, is indicated under accelerated approval for first-line treatment in the subset of this patient population whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1), based on prior KEYNOTE-811 results Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced overall survival (OS) results from the final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and
Approval of KEYTRUDA plus enfortumab vedotin brings a potential new first-line standard of care to these patients in the European Union Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. The decision follows the adoption of the European Society for Medical Oncology and European Association of Urology clinical guidelines recommending the combination as the preferred first-line treatment for these patients, regardless of platinum eligibility. This approval by the EC also follows the positive recommendation from the Committee for Medicinal Products for Human Use received in July 2024 , which was based on results from the first interim analysis of the Phase 3 KEYNOTE-A39 trial
RAHWAY, N.J., Aug. 22, 2024 – Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that PD-L1 expression thresholds for certain advanced gastric, gastroesophageal junction (GEJ) and esophageal cancer indications for immune checkpoint inhibitors, including KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, will be discussed during an upcoming meeting of the […]