Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval as a Monotherapy for 1L+ Recurrent Locally Advanced or Metastatic Esophageal Cancer Expressing PD-L1 (CPS ≥10)

Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval as a Monotherapy for 1L+ Recurrent Locally Advanced or Metastatic Esophageal Cancer Expressing PD-L1 (CPS ≥10)

Shots:

  • The approval is based on two studies, KEYNOTE-181 study results involve assessing of Keytruda (200mg, q3w) vs CT (paclitaxel/docetaxel) in 628 patients in a ratio (1:1) with 1L+ LA/m- EC with disease progression. The KEYNOTE-180 study results involve assessing of Keytruda in 121 patients with 1L+ LA/m- EC with disease progression
  • KEYNOTE-181 results: In ESCC patients with PD-L1 expression (CPS ≥10) (80% vs 88%); OS (10.3 vs 6.7mos.); mPFS (3.2 vs 2.3 mos.); ORR (22% vs 7%); CRR (5% vs 1%); DOR (9.3 vs 7.7mos.). KEYNOTE-180 results: 20% ORR with DOR ranged from 4.2-25.1+ mos.
  • Keytruda is a mAb targeting PD-1 and blocking its interaction with PD-L1 and PD-L2 thereby activating T-lymphocytes affecting both tumor and healthy cells

 Click here to­ read full press release/ article | Ref: Merck | Image: Austin Chronicle