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

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

Shots:

  • The EC has approved two regimens of Keytruda (monothx. and in combination with platinum and 5-fluorouracil (5-FU) CT), based on P-III KEYNOTE-048 study evaluating Keytruda vs SoC (cetuximab with carboplatin/cisplatin + 5-FU) in 882 patients in a ratio (1:1:1) with confirmed metastatic or recurrent HNSCC prior not treated with systemic therapy and incurable by local therapies
  • The P-III KEYNOTE-048 study results of monothx & combination regimen: OS (77% & 73% vs 90% & 91%); PFS (89% & 88% vs 93% & 94%); ORR (19.1% & 36% vs 35% & 36%); DOR (81% & 54% vs 36% & 34%)
  • KEYTRUDA is an anti-PD-1 therapy, act by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2 thus activating T lymphocytes affecting both tumor and healthy cells

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