Merck: Phase 3 KEYNOTE-040 Trial Fails To Meet Primary Endpoint - Quick Facts

(RTTNews) - Merck (MRK) reported that the pivotal phase 3 KEYNOTE-040 trial investigating KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma did not meet its pre-specified primary endpoint of overall survival. The company said the safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of KEYTRUDA; no new safety signals were identified.

"We are encouraged by the positive impact that KEYTRUDA has had on many cancer patients, including those with previously treated recurrent or metastatic head and neck cancer, and we remain confident that KEYTRUDA is an important therapy for this difficult-to-treat cancer," said Roger Dansey, M.D., senior vice president and therapeutic area head, said.