Biotechnology company CEL-SCI Corporation (NYSE American: CVM) reported on Wednesday that it welcomes the US FDA's 13 June 2025 approval of Merck's Keytruda (pembrolizumab) for resectable locally advanced head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression (CPS ≥1), highlighting the decision as a positive regulatory signal for its own immunotherapy candidate, Multikine.

Merck received priority review in February 2025 for Keytruda based on interim results from the Phase 3 KEYNOTE-689 trial, which showed a 30% reduction in risk of recurrence and progression versus standard of care in PD-L1-positive patients. However, the trial did not demonstrate an overall survival benefit, and no benefit was observed in patients with low or negative PD-L1 expression.

In contrast, CEL-SCI's Phase 3 study found that Multikine significantly improved outcomes in PD-L1 low and negative patients (TPS