Merck announces Phase 3 KEYNOTE-119 trial does not meet OS primary endpoint
Merck announced that the Phase 3 KEYNOTE-119 trial evaluating Keytruda, Merck's anti-PD-1 therapy, as monotherapy for the second- or third-line treatment of patients with metastatic triple-negative breast cancer, or TNBC, did not meet its pre-specified primary endpoint of superior overall survival, or OS, compared to chemotherapy. Other endpoints were not formally tested per the study protocol because the primary endpoint of OS was not met. The safety profile of KEeytruda in this trial was consistent with that observed in previously reported studies involving patients treated with Keytruda monotherapy; no new safety concerns were identified. Results will be presented at an upcoming medical meeting. The Keytruda breast cancer clinical development program encompasses several internal and external collaborative studies, including three ongoing registration-enabling studies in TNBC.