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New Protocol: Pembrolizumab in combination with gemcitabine and cisplatin for patients with advanced biliary tract cancer

New Protocol: Pembrolizumab in combination with gemcitabine and cisplatin for patients with advanced biliary tract cancer
Study:
  • Phase III, double-blind, randomized, controlled, multicenter, open-label trial (KEYNOTE-966)
  • Previously untreated, unresectable, locally advanced or metastatic biliary tract cancer
  • Pembrolizumab + Gemcitabine + Cisplatin (n=533) vs. Gemcitabine + Cisplatin (n=536)
Efficacy:
  • mPFS: 6.5 vs 5.6 mos, p=0.023
  • 6 months PFS: 52% vs. 46%
  • 12 months PFS: 25% vs 20%
  • mOS: 12.7 vs. 10.9 mos , p=0034
  • 12 months OS: 52% vs.44%
  • 24 months OS: 25% vs.18%
  • mDoR: 9.7 vs 6.9 mos
Safety:
  • Grade≥3 AEs: Neutropenia (49% vs 45%), Anemia (29% vs. 29%), fatigue (6% vs. 4%)

Lancet Oncol, 16 APR, 2023

Kelley Kate R et al. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomized, double-blind, placebo-controlled, phase 3 trial,

http://doi.org/10.1016/S0140-6736(23)00727-4

Reviewed by Elvin CHALABİYEV, MD on MAY 10, 2023

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