-Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced 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 (HNSCC) did not meet its pre-specified primary endpoint of overall survival (OS) (HR, 0.82 [95% CI, 0.67-1.01]; p = 0.03 [one-sided]). The safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of KEYTRUDA; no new safety signals were identified.
In August 2016, the U.S. Food and Drug Administration (FDA) approved KEYTRUDA for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy. The current indication remains unchanged and clinical trials continue, including KEYNOTE-048 (ClinicalTrials.gov, NCT02358031), a phase 3 clinical trial of KEYTRUDA in the first-line treatment of recurrent or metastatic HNSCC.
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