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

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

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  • 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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Ref: Businesswire | Image: Merck


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