Keytruda monotherapy improves survival by 39% in PD-L1-positive SCCHN patients

Merck & Co. Inc. (NYSE:MRK) reported detailed data from the Phase III KEYNOTE-048 trial to treat recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) showing that first-line treatment with Keytruda pembrolizumab as monotherapy significantly improved overall survival (OS) by up to 39% in PD-L1-positive patients vs. standard of care (SOC). Data were presented at the European Society for Medical Oncology meeting in Munich. The pharma previously reported that the trial met its primary endpoint of improving OS (see "Keytruda Monotherapy Meets in Phase III for First-Line SCCHN").

The open-label trial enrolled 882 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. The trial's endpoints were evaluated in patients whose tumors expressed PD-L1 with a Combined Positive Score (CPS) of at least 20 points and of at least one point, and in the total population regardless of PD-L1 expression, based on a fixed sequential testing strategy...