Merck Reports Result of Keytruda (pembrolizumab) in P-III KEYNOTE-048 Study as a 1L Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Merck Reports Result of Keytruda (pembrolizumab) in P-III KEYNOTE-048 Study as a 1L Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Shots:

  • The P-III KEYNOTE-048 study results involves assessing of Keytruda + CT (carboplatin/cisplatin + 5-FU) and Keytruda as monothx. vs EXTREME regimen in 882 patients with recurrent or metastatic HNSCC, whose tumor expressed CPS≥20 & CPS ≥1, presented at ASCO 2019
  • The P-III KEYNOTE-048 study results: @ CPS≥20 & CPS ≥1 for combination, 40% & 35% reduction in death; OS (14.7 & 13.6 vs 11 & 10.4 mos.); ORR (42.9% & 36.4% vs 38.2% & 35.7%); mDOR (7.1 & 6.7 vs 4.2 & 4.3 mos.); for monthx, OS (11.5 vs 10.7mos.); ORR (16.9% vs 36.0%); mDOR (22.6 vs 4.5mos.) respectively
  • Keytruda is an anti PD-1 therapy, inhibits the interaction of PD-1 and its ligands, PD-L1 and PD-L2 by activating T-lymphocytes, currently evaluating in 1000+ clinical studies for multiple cancers and has received FDA’s PR to sBLA with its expected PDUFA date on Jun 10, 2019

Click here to read full press release/ article | Ref: Merck | Image: Daily Mail