KEYNOTE-158

NCT02628067 📎

Regimen

Experimental
Pembrolizumab 200 mg Q3W until progression or toxicity (up to 2 years).
Control
N/A (single-arm)

Population

Multi-cohort phase 2 basket trial of advanced solid tumors (including breast) with tumor mutational burden-high (TMB-H, >=10 mut/Mb by FoundationOne CDx), progressed on prior therapy. Subset relevant to TNBC.

Key finding

KEYNOTE-158 supported the tumor-agnostic FDA approval (June 2020) of pembrolizumab for TMB-H unresectable/metastatic solid tumors after prior therapy. Provides a tissue-agnostic option for TMB-H metastatic TNBC beyond PD-L1-directed strategies.

Source: PMID 32919526

Timeline

  • Publication: 2020 Oct

Guideline citations

  • NCCN BREAST