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