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KEYTRUDA Is First Checkpoint Inhibitor Approved in Europe to Treat MSI-H or dMMR Colorectal Cancer
European Approval Based on Results From KEYNOTE-177 Trial Demonstrating KEYTRUDA Significantly Reduced Risk of Disease Progression or Death by 40% Compared With Chemotherapy
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. 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 [95% CI, 0.45-0.80]; p=0.0002) compared with chemotherapy (investigator s choice: mFOLFOX6 [oxaliplatin, leucovorin and fluorouracil (FU)] with or without bevacizumab or cetuximab; or FOLFIR
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Almost 40% of progressive, advanced gastrointestinal (GI) tumors with mismatch repair deficiency (dMMR) responded to the investigational anti-PD-1 agent dostarlimab, according to a preliminary clinical trial.
Overall, 38.7% of 106 patients responded to single-agent treatment with monoclonal antibody, including 36.2% of colorectal cancers (CRC) and 43.2% of all other tumors, which were primarily GI in origin. About three-fourths of patients had some degree of tumor shrinkage. During a median follow-up exceeding 1 year, median duration of response had yet to be reached.
Dostarlimab was well tolerated, as fewer than 10% of patients had ≥3 treatment-related adverse events (TRAEs), reported Thierry Andre, MD, of Sorbonne University and Saint-Antoine Hospital in Paris, at the Gastrointestinal Cancers Symposium virtual meeting.