The FDA has granted accelerated approval for Keytruda + chemotherapy to treat locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1.- Merck Inc.

Merck announced that the FDA has given accelerated approval for Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] greater than 10) as determined by an FDA-approved test. The approval is based on results from the Phase III KEYNOTE-355 trial, where Keytruda in combination with chemotherapy – paclitaxel (pac), paclitaxel protein-bound (commonly known as nab-paclitaxel) or gemcitabine (gem) and carboplatin (carbo) – significantly reduced the risk of disease progression or death by 35% for patients whose tumors express PD-L1 versus the same chemotherapy regimens alone (HR=0.65 [95% CI, 0.49, 0.86]; p=0.0012). Events were observed in 62% (n=136/220) of these patients receiving Keytruda in combination with pac, nab-paclitaxel or gem/carbo versus 77% (n=79/103) with the same chemotherapy regimens alone. In the trial, 38% of patients had tumors expressing PD-L1 with CPS greater than 10. This indication is approved under accelerated approval based on progression-free survival (PFS); continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.