BioNTech's head and neck cancer mRNA vaccine fails to extend progression-free survival in Phase 3 trial

BioNTech reported that its experimental mRNA immunotherapy BNT113 did not meet its primary endpoint in a Phase 3 trial for a specific head and neck cancer, failing to improve progression-free survival.

The trial, called AHEAD-MERIT, combined BNT113 with Merck's Keytruda. Analysts noted that while the company still hopes for an overall survival benefit, the lack of PFS improvement makes that outcome less likely.

The setback adds to recent difficulties for BioNTech's mRNA cancer pipeline, including earlier halts of autogene cevumeran trials in bladder and colorectal cancers, reflecting broader challenges for mRNA cancer vaccines.