Keytruda closes in on new head and neck indication

Merck & Co (NYSE: MRK) has announced results from the Phase III KEYNOTE-689 trial of Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC).

Results at the first interim analysis of the trial showed that the anti-PD-1 therapy significantly improved event-free survival (EFS) as part of a perioperative treatment regimen with adjuvant standard of care (SOC) radiotherapy with or without cisplatin compared to adjuvant standard of care (SOC) radiotherapy with or without cisplatin alone in patients with resectable LA-HNSCC. These data are being presented for the first time today during a Plenary Session at the American Association for Cancer Research (AACR) Annual Meeting 2025 and were selected for the AACR press program.

The US Food and Drug Administration (FDA) has granted priority review to the drugmaker's application for Keytruda in this application, with an FDA decision due by June 23.