Keytruda monotherapy meets in Phase III for first-line SCCHN

Merck & Co Inc. (NYSE:MRK) said first-line treatment with Keytruda pembrolizumab as monotherapy met the primary endpoint of improving overall survival (OS) in PD-L1-positive patients vs. standard of care (SOC) in the Phase III KEYNOTE-048 trial to treat recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The company said the data will be presented at a medical meeting and submitted to worldwide regulatory authorities.

The open-label trial is enrolling about 825 patients to receive Keytruda as a monotherapy, Keytruda plus platinum chemotherapy and 5-fluorouracil (5-FU), or SOC with Erbitux cetuximab plus platinum chemotherapy and 5-FU...