Decision marks fifth approval for KEYTRUDA in lung cancer in the EU Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy. This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in September 2023 and was based on results from the Phase 3 KEYNOTE-091 trial. At a median follow up time of 46.7 months, KEYTRUDA demonstrated a clinically meaningful improvement in disease-free survival (DFS) in patients who received adjuvant chemotherapy, reducing the risk of disease recurrence or death by 24% (HR=0.76 [95% CI, 0.64-0.91]). At an earlier prespecified interim analysis, with a median follow-up of 32.4 months, KEYTRUDA
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KEYTRUDA® (pembrolizumab) is the first anti-PD-1 therapy to demonstrate statistically significant improvement in OS as a neoadjuvant and adjuvant treatment versus pre-operative chemotherapy for NSCLC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Phase 3 KEYNOTE-671 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS). At a pre-specified interim analysis, KEYTRUDA plus chemotherapy before surgery (neoadjuvant), followed by resection and KEYTRUDA as a single agent after surgery (adjuvant), demonstrated a statistically significant and clinically meaningful improvement in OS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients. The safety profile of KEYTRUDA was consistent with that observed in previously
Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act
Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE‑966 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma. “Patients diagnosed with locally advanced unresectable or metastatic biliary tract cancer face a challenging disease with poor survival outcomes, underscoring the need for new treatment options that may help extend their lives,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “The CHMP’s positive opinion brings us one step closer to providing a new immunotherapy regimen, which has
KEYTRUDA significantly improved DFS as adjuvant therapy versus observation for patients with localized MIUC and locally advanced urothelial carcinoma First positive study for KEYTRUDA as adjuvant therapy for these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the Phase 3 AMBASSADOR (A031501) trial (KEYNOTE-123) evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with localized muscle-invasive urothelial carcinoma (MIUC) and locally advanced urothelial carcinoma versus observation. At a pre-specified interim analysis review conducted by an independent Data Monitoring Committee, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in DFS versus observation in these patients after surgery. The trial will continue to evaluate its other dual primary endpoint of overall survival (OS). The safety
The initiation of the second clinical trial in the INTerpath program represents rapid expansion in research for additional tumor types for individualized neoantigen therapy, V940 (mRNA-4157) Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Moderna, Inc. (Nasdaq: MRNA), today announced the initiation of INTerpath-002, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia. “As lung cancer is the leading cause of cancer death worldwide, there is a need for continued scientific advancements to help fight this disease at earlier stages when patients have the best chance for better
AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has informed AstraZeneca that the agency will extend by three months the Prescription Drug User Fee Act (PDUFA) date for the pending supplemental new drug application (sNDA) for LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). The purpose of the extension is to provide further time for the full review of the submission. The companies will continue to work with the FDA to facilitate the completion of the agency’s review. The sNDA for LYNPARZA in combination with abiraterone and prednisone or prednisolone is based on the Phase 3 PROpel trial, results of which were published in NEJM Evidence in June 2022. The application was granted priority review, and AstraZeneca and Merck are committed to working with the FDA to
KEYTRUDA is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients Approval marks third FDA-approved indication for KEYTRUDA in cervical cancer and 39th indication for KEYTRUDA in the US 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 chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer. The approval is based on data from the Phase 3 KEYNOTE-A18 trial, in which KEYTRUDA plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group. This approval marks the third
Opinion granted based on positive overall survival results from the Phase 3 KEYNOTE-859 trial If approved, a KEYTRUDA combination would become an option in the EU for the treatment of both HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma in tumors expressing PD-L1 (CPS ≥1) 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 a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). “This positive CHMP opinion builds on our efforts to treat advanced gastric and gastroesophageal junction cancer in Europe, including in
This regimen with KEYTRUDA is the first and only anti-PD-1/L1 therapy in resectable NSCLC to demonstrate a statistically significant improvement in overall survival versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone, regardless of PD-L1 expression KEYTRUDA-based regimen also improved event-free survival, the trial’s other dual primary endpoint (median EFS by nearly 2.5 years, 47.2 months for the KEYTRUDA arm versus 18.3 months in the placebo arm) Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). These late-breaking data are being presented for the first time today during a proffered paper session at the European Society