Shots:

• The approval is based on pivotal P-III KEYNOTE-177 study involves assessing of Keytruda (200mg- q3w) vs CT regimen in 307 patients in a ratio (1:1) with previously untreated metastatic MSI-H or dMMR colorectal cancer
• Results: reduction in the risk of disease progression or death by 40%- median PFS (16.5mos. vs 8.2mos); ORR (44% vs 33%); CR (11% vs 4%) and PR (33% vs 29%); lower incidence of Grade ≥3 TRAEs (22% vs 66%)- and no new toxicities observed
• Keytruda is the 1st anti-PD-1/L1 therapy approved in Europe to treat MSI-H or dMMR Colorectal Cancer. Additionally- approval allows marketing in all 27 EU member states

 ­ Ref: Businesswire | Image: Merck