Merck, known as MSD outside the United States and Canada, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of adult patients with metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This recommendation is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which KEYTRUDA, as a monotherapy, demonstrated a significant improvement in progression-free survival compared to chemotherapy (investigator’s choice: mFOLFOX6 with or without bevacizumab or cetuximab; or FOLFIRI with or without bevacizumab or cetuximab), a current standard of care.

“Patients in Europe with MSI-H/dMMR colorectal cancer have had only chemotherapy-containing regimens available to them in the first-line treatment setting and have historically faced poor outcomes,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories. “This positive EU CHMP opinion reinforces the potential of KEYTRUDA as a new option for patients with MSI-H/dMMR colorectal cancer and illustrates our ongoing commitment to pursuing biomarker research to help address the needs of patients who have few effective options.”

Data from KEYNOTE-177 were presented at the virtual scientific program of the 2020 American Society of Clinical Oncology Annual Meeting and were published in The New England Journal of Medicine. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the first quarter of 2021.