KEYNOTE-355

NCT02819518 📎

Regimen

Experimental
Pembrolizumab 200 mg Q3W + investigator's choice chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine/carboplatin).
Control
Placebo + identical chemotherapy.

Population

Previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer, at least 6 months since prior (neo)adjuvant chemotherapy.

Key finding

KEYNOTE-355 established pembrolizumab + chemotherapy as standard 1L in PD-L1 CPS>=10 metastatic TNBC (NCCN category 1; FDA approved November 2020). Benefit restricted to PD-L1-high tumors, confirmed OS gain.

Source: PMID 33278935

Timeline

  • Publication: 2020 Dec 5

Guideline citations

  • NCCN BREAST