The U.S. Food and Drug Administration (FDA) approved Merck’s KEYTRUDA (pembrolizumab) on June 13, 2025, for adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). This approval was based on interim results from Keytruda’s Phase 3 KEYNOTE-689 trial.
Merck’s application received the FDA’s priority review on February 25, 2025. The KEYNOTE-689 trial showed Keytruda reduced the risk of recurrence and progression by 30% compared with standard of care in patients with higher PD-L1 expression, but did not demonstrate an improvement in overall survival.
CEL-SCI Corporation noted that patients with low to zero levels of PD-L1 did not benefit from Keytruda. In contrast, CEL-SCI’s Phase 3 study showed Multikine reduced the risk of death by 66% and extended 5-year overall survival to 73% in patients with low to zero PD-L1 expression, a population representing about 70% of patients in their study.
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