Patients were randomized 1:1 to receive KEYTRUDA (200 mg intravenously) every three weeks or investigator’s choice of the following chemotherapy regimens given intravenously every two weeks: Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible. Microsatellite instability (MSI) or mismatch repair (MMR) tumor status was determined locally using polymerase chain reaction or immunohistochemistry, respectively. The approval was based on data from KEYNOTE-177, a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated metastatic MSI-H or dMMR colorectal cancer. Following Brexit, in line with the reliance route, this approval is also valid in Great Britain. This approval allows marketing of KEYTRUDA monotherapy in all 27 European Union (EU) member states plus Iceland, Lichtenstein, Norway and Northern Ireland. “Our efforts in biomarker-driven research across tumor types – including colorectal cancer, the most common type of gastrointestinal cancer – will continue to help us bring new options to patients across the globe.” Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “This decision by the European Commission, which was based on the important findings from KEYNOTE-177, exemplifies our commitment to using biomarkers such as MSI/MMR to help identify patients who are most likely to respond to KEYTRUDA,” said Dr. “With this approval, patients with metastatic colorectal cancer that is MSI-H or dMMR status will gain a monotherapy treatment option that has shown superior progression-free survival compared to standard of care chemotherapy.” Antoine Hospital, Assistance Publique Hôpitaux de Paris. Thierry Andre, professor of medical oncology at Sorbonne University and head of the medical oncology department at St. “Before the KEYNOTE-177 trial, conventional chemotherapy with targeted therapy was the standard of care for patients with metastatic colorectal cancer who have tumors that are MSI-H/dMMR,” said Dr. This approval marks the first gastrointestinal indication for KEYTRUDA in Europe and makes KEYTRUDA the first anti-PD-1/L1 therapy approved in Europe for these patients. There was a lower incidence of Grade ≥3 treatment-related adverse events (TRAEs) with KEYTRUDA compared with chemotherapy (22% versus 66%), and no new toxicities were observed. In the trial, treatment with KEYTRUDA also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months versus 8.2 months ). This approval is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 p=0.0002) compared with chemotherapy (investigator’s choice: mFOLFOX6 with or without bevacizumab or cetuximab or FOLFIRI with or without bevacizumab or cetuximab). Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. KEYTRUDA Is First Checkpoint Inhibitor Approved in Europe to Treat MSI-H or dMMR Colorectal CancerĮuropean Approval Based on Results From KEYNOTE-177 Trial Demonstrating KEYTRUDA Significantly Reduced Risk of Disease Progression or Death by 40% Compared With Chemotherapy
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