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Merck Nabs EU Keytruda Approval for MSI-High, Mismatch Repair Deficient Colorectal Cancer

This article has been updated to note that the median progression-free survival was more than double in the Keytruda arm in Keynote-177 compared to the comparator arm, not nearly double.

NEW YORK – Merck on Tuesday said the European Commission has approved pembrolizumab (Keytruda) as a first-line therapy for metastatic colorectal cancer patients in the European Union whose tumors are microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The approval comes roughly a month and a half after the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the PD-1 inhibitor based on the results of the Phase III Keynote-177 trial. The trial pitted pembrolizumab against investigators' choice of chemotherapy, with or without bevacizumab (Genentech's Avastin) or cetuximab (Eli Lilly's Erbitux). Median progression-free survival was more than double in the pembrolizumab arm compared to the comparator arm, 16.5 months versus 8.2 months.

The US Food and Drug Administration approved pembrolizumab for this same indication in June 2020, marking the first frontline monotherapy immune checkpoint inhibitor approved for this patient population. In Europe, the approval marks the first pembrolizumab approval for any gastrointestinal cancer indication.  

"This decision by the European Commission … exemplifies our commitment to using biomarkers such as MSI/MMR to help identify patients who are most likely to respond to Keytruda," Scot Ebbinghaus, VP of clinical research at Merck Research Laboratories, said in a statement. "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."