2/28/2024 0 Comments Keynote 158 trialThe KEYNOTE-164 trial enrolled 124 patients with unresectable or metastatic MSI-H or dMMR colorectal cancer that progressed following prior fluoropyrimidine-based therapy in combination with irinotecan and/or oxaliplatin. The approval was based on data from KEYNOTE-164 ( NCT02460198) and KEYNOTE-158 ( NCT02628067), multicenter, non-randomized, open-label Phase 2 trials evaluating KEYTRUDA in patients with advanced MSI-H or dMMR solid tumors. This approval allows marketing of KEYTRUDA monotherapy in all 27 European Union (EU) member states plus Iceland, Lichtenstein, Norway and Northern Ireland. “The EU approval of KEYTRUDA is an important milestone for patients living with these MSI-H/dMMR cancers who have had few treatment options and face worse outcomes when diagnosed at an advanced stage.” Aurélien Marabelle, Immuno-Oncologist at Gustave Roussy Cancer Center and Professor of Clinical Immunology at the University of Paris Saclay. “In the two studies supporting this approval, KEYTRUDA monotherapy showed strong objective response rates and durability of response in patients with five different types of MSI-H/dMMR cancers,” said Dr. Building on that approval, we are pleased that KEYTRUDA is now approved for the treatment of additional MSI-H/dMMR tumors, in certain second- or later-line patients with colorectal, endometrial, gastric, small intestine or biliary cancer.” “For patients with MSI-H/dMMR colorectal cancer, KEYTRUDA monotherapy was approved in Europe as a first-line option in January 2021. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. ![]() “Our company has a strong track record of applying precision medicine, through biomarkers like MSI-H and dMMR, to help identify patients most likely to respond to KEYTRUDA based on the genetic makeup of their individual cancer,” said Dr. KEYTRUDA is also approved for the first-line treatment of metastatic MSI-H or dMMR colorectal cancer in adults. ![]() This is the second approval for KEYTRUDA in Europe based on the MSI-H/dMMR biomarker. 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 for the treatment of microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) tumors in adults with: unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation unresectable or metastatic gastric, small intestine or biliary cancer, who have disease progression on or following at least one prior therapy. KEYTRUDA is the First Immunotherapy to be Approved for Patients with MSI-H/dMMR Biomarkers in Five Different Types of Cancer in Europe
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