New Reference: Pembrolizumab with Chemotherapy in Advanced Gastric Cancer


  • Study

    Double-blind, multicenter, randomised, phase 3 study (Keynote 859)
    Previously untreated locally advanced/metastatic HER2 negative GEJ and gastric adenocancer
    Pembrolizumab + Cht (n=790) vs. PBO + Cht (n=789)



  • Efficacy

    ITT
    mOS: 12.9 vs 11.5 mos, HR:0.78, p<0.001
    mPFS: 6.9 vs. 5.6 mos, HR:0.76, p<0.001
    CPS≥1 group:
    mOS: 13.0 vs 11.4 mos, HR:0.74, p<0.001
    mPFS: 6.9 vs. 5.6 mos, HR:0.72, p<0.001
    CPS≥10 group:
    mOS: 15.7 vs 11.8 mos, HR:0.65, p<0.001
    mPFS: 8.1 vs. 5.6 mos, HR:0.62, p<0.001



  • Safety

    Grade≥3 AEs: Neutropenia (9% vs.8%), anemia (9% vs.7%), thrombocytopenia (7% vs 5%).



  • Lancet Oncol 2023; 24: 1181–95

    Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial

    http://doi.org/10.1016/S1470-2045(23)00515-6

    Reviewed by Elvin Chalabiyev, MD on Nov 20, 2023