New Reference: Pembrolizumab in Triple-Negative Breast Cancer


  • Study

    Randomized, double-blind, placebo-controlled trial (KEYNOTE-522)
    Previously untreated stage II or III triple-negative breast cancer
    Neoadjuvant/adjuvant pembrolizumab (n=784) or placebo (n=390) plus standard therapy



  • Efficacy

    36-mo-EFS: 84.5% [81.7%-86.9%] vs 76.8% [72.2%-80.7%], HR: 0.63 [0.48 – 0.82, p<0.001]
    36-mo-OS: 89.7% vs 86.9%



  • Safety

    Grade 3 AE >= 77.1% vs 73.3%
    Discontinuation of the trial regimen: 27.7% vs 14.1%
    Serious treatment-related AE: 34.1% vs 20.1%



  • N Engl J Med 2022; 386:556-567

    Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer

    http://doi.org/10.1056/NEJMoa2112651

    Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022