Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval for 1L Treatment of Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval for 1L Treatment of Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma

Shots:

  • The approval is based on P-III KEYNOTE-048 study results assessing Keytruda as monothx. & in combination with platinum and fluorouracil (FU) vs EXTREME regimen in 882 patients in ratio (1:1:1) with metastatic or unresectable HNSCC with & without PD-L1 tumor expression respectively
  • Results: monothx. and combination therapy, CPS ≥1 & CPS ≥20, OS (69% & 82% vs 81% & 78%) and (70% vs 80%); PFS (88% & 85% vs 91% & 91%) and (87% vs 91%); DOR (20.9 & 20.9 mos. vs 4.5 & 4.2mos.) and (6.7 vs 4.3) respectively
  • Keytruda (100mg) is a mAb, blocking the interaction b/w PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes affecting both tumor cells and healthy cells

Click here to read full press release/ article | Ref: Merck | Image: Video Blocks