Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®? (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS]1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent. The approval is based on data from the pivotal Phase 3 KEYNOTE-689 trial, the results of which were presented at the American Association for Cancer Research (AACR) Annual Meeting on April 27, 2025.
At the trial's first pre-specified interim analysis, KEYTRUDA before surgery (neoadjuvant), then continued after surgery (adjuvant) in combination with standard of care (SOC), RT with or without cisplatin, followed by KEYTRUDA alone, reduced the risk of event-free survival (EFS) events (defined as disease recurrence, disease progression, or death) by 30% (HR=0.70 [95% CI, 0.55-0.89; p=0.00140) in patients whose tumors expressed PD-L1 (CPS 1) compared to adjuvant SOC. Among the CPS 1 population, median EFS was 59.7 months (95% CI, 37.9-not reached) in the KEYTRUDA arm versus 29.6 months (95% CI, 19.5-41.9) in the SOC arm.
