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

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

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  • 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

Ref: Merck | Image: Merck

Click here to­ read the full press release 

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