Checkpoint Inhibitor Plus CRT Misses End Point in Advanced Head and Neck Cancer

In patients with locally advanced head and neck squamous cell carcinoma (HNSCC), the combination of the checkpoint inhibitor pembrolizumab (Keytruda, Merck) plus chemoradiation therapy (CRT) fell short of the primary end point of event-free survival (EFS) in a phase 3 multicenter trial.

The 17% reduction in the hazard ratio (HR) for EFS  came close to significance (HR, 0.83; P=0.042), but the predefined statistical threshold of superiority for this trial was P≤0.0242, reported