FDA approval of pembrolizumab with chemotherapy for locally recurrent unresectable or metastatic triple‑negative breast cancer

Approval is based on the Phase III KEYNOTE-355 trial; addition of pembrolizumab to chemotherapy significantly reduced risk of disease progression or death by 35% for patients whose tumours express PD-L1 (CPS ≥10) vs chemotherapy alone (HR=0.65; 95% CI, 0.49, 0.86; p=0.0012).

Source:

Biospace Inc.