Merck’s Keytruda (pembrolizumab) Receives EC’s Approval as 1L Treatment for Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Colorectal Cancer

January 27, 2021 Auto Bot 1L, approval, colorectal cancer, EC, Merck, receives, regulatory, Treatment 0

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

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Biospace

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