Study
| Phase 3, randomized, double-blind, international trial |
| Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer |
| Pembrolizumab (200 mg every 3 weeks) plus chemotherapy (n:566) or chemotherapy (n:281) |
Efficacy
| mOS:23.0 m vs 16.1 months (HR:0.73, P=0.01) in CPS10 subgroup |
| mOS:17.6 m vs 16 months (HR:0.86, P=0.11) in CPS1 subgroup |
| ORR:52.7% vs 40.8 in CPS10 subgroup |
Safety
| Any grade AEs: 96.3 vs 95% (anemia: 49.1% vs 45.9%; neutropenia 41.1% vs 38.1%; nausea 39.3% vs 41.3%) |
| Grade ≥3 AEs 68.1% vs 66.9% |
| Treatment related death: 2 patients and no |
| Immune-mediated adverse events 26.5% vs 6.4% |
N Engl J Med 2022; 387:217-226
Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer
http://doi.org/10.1056/NEJMoa2202809
Reviewed by Hasan Cagri Yildirim, MD on Nov 26, 2022
