EMA's Advisory Group Backs Approval For Merck's Keytruda In Various Cancer Settings

The European Medicines Agency's advisory group CHMP has adopted a positive opinion recommending approval of Merck & Co Inc MRK for microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors.

• The opinion covers Keytruda as monotherapy for certain colorectal, gastric, small intestine (biliary cancer), and endometrial carcinoma in patients who have disease progression on or following at least one prior therapy.
• The recommendation was based on results from the Phase 2 KEYNOTE-158 trial and Phase 2 KEYNOTE-164 trial, both of which supported the FDA'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.
• Related: FDA Approves Second Indication For Merck's Keytruda In Endometrial Cancer.
• The CHMP also backed Keytruda combined with chemotherapy, with or without bevacizumab for cervical cancer in adults whose tumors express PD-L1.
• The recommendation is based on Phase 3 KEYNOTE-826 trial results. Keytruda exhibited a statistically significant improvement in overall and progression-free survival compared to chemotherapy. 
• The Keytruda regimen showed an objective response rate (ORR) of 68% versus 50%, respectively. 
• The European Commission will now review the CHMP's recommendation for marketing authorization in the European Union, and a final decision is expected in Q2 of 2022.
• Price Action: MRK shares are up 0.72% at $80.77 during the market session on the last check Friday.