New Indication: Pembrolizumab for MSI-High Colorectal Cancer


  • Study

    Randomised, open-label, phase 3 study (KEYNOTE-177)
    Untreated microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer
    Pembrolizumab 200 mg every 3 weeks (N:153) or to the investigator’s choice (N:154)



  • Efficacy

    mOS: NR vs 36·7 months [HR:0·74; 0·53–1·03; p=0·036]
    mPFS: 16·5 vs 8·2 months [HR 0·59, 95% CI 0·45–0·79]



  • Safety

    Grade >= 3 AEs: 22% vs 66%
    Grade >= 3 AEs for pembrolizumab: increased ALT (2%), colitis (2%), diarrhoea (2%), and fatigue (2%)
    Grade >= 3 AEs for chemotherapy: neutropenia (15%), diarrhoea ( 10%), fatigue (9%)



  • Lancet Oncol. 2022 May;23(5):659-670

    Pembrolizumab versus chemotherapy for microsatellite instability-high or mismatch repair-deficient metastatic colorectal cancer (KEYNOTE-177): final analysis of a randomised, open-label, phase 3 study.

    http://doi.org/10.1016/s1470-2045(22)00197-8

    Reviewed by Hasan Cagri Yildirim, MD on Jul 16, 2022