KEYNOTE-522

NCT03036488 📎

Regimen

Experimental
Neoadjuvant pembrolizumab 200 mg Q3W + paclitaxel/carboplatin x 4 cycles, then pembrolizumab + doxorubicin (or epirubicin)/cyclophosphamide x 4 cycles, followed by surgery and adjuvant pembrolizumab for up to 9 cycles.
Control
Same chemotherapy backbone with placebo, followed by adjuvant placebo.

Population

Previously untreated non-metastatic (cT1c N1-2 or cT2-4 N0-2) triple-negative breast cancer, regardless of PD-L1 status.

Key finding

KEYNOTE-522 established perioperative pembrolizumab + platinum/anthracycline-based chemotherapy as the new standard for stage II-III TNBC (NCCN v2.2026 category 1, preferred). Benefit independent of PD-L1 status. FDA approved July 2021.

Source: PMID 32101663

Timeline

  • Publication: 2020 Feb 27

Guideline citations

  • NCCN BREAST