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
