Merck gets positive EU CHMP opinion for Keytruda for patients with MSI-H or dMMR tumors in five different types of cancer
Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.
Kenilworth: Merck, known as MSD outside the United States and Canada, has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of the following microsatellite instability-high (MSI-H) or mismatch repair deficient (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.
The CHMP's recommendation was based on results from the Phase 2 KEYNOTE-158 trial as well as results from the Phase 2 KEYNOTE-164 trial, both of which also supported the U.S. Food and Drug Administration's accelerated approval of KEYTRUDA as the first cancer treatment approved based on a biomarker in MSI-H or dMMR solid tumors, regardless of tumor type.
KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.
"We are committed to advancing the use of biomarkers to identify patients most likely to respond to KEYTRUDA," said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories. "This positive CHMP opinion reinforces the predictive value of MSI-H/dMMR across many different cancer types and the importance of biomarker testing. KEYTRUDA has already become an important first-line treatment option for certain patients in Europe with MSI-H or dMMR colorectal cancer, and we are pleased the CHMP has recommended KEYTRUDA as a monotherapy for additional patients with MSI-H or dMMR tumors."
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 second quarter of 2022.
