CHMP positive for Keytruda as first-line treatment in metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer.- Merck Inc.

Merck Inc, announced 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 III 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. About Microsatellite Instability-High : Microsatellite instability (or MSI) is defined by the National Cancer Institute as a change that occurs in the DNA of certain cells, such as tumor cells, in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different from the number of repeats that was in the DNA when it was inherited. The cause of MSI may be a defect in the ability to repair mistakes made when DNA is copied in the cell. This defect is also referred to as mismatch repair deficiency (dMMR). It is estimated approximately 5-15% of colorectal cancer patients have tumors that score as either MSI-H or dMMR when testing is performed.