BioNTech’s mRNA cancer vaccine misses key endpoint in head-and-neck trial, study to continue

BioNTech reported that its mRNA cancer immunotherapy BNT113 did not improve progression‑free survival when added to Keytruda in patients with HPV16‑positive head and neck squamous cell carcinoma. The phase 2/3 Ahead‑Merit trial therefore failed to meet one of its two primary efficacy goals.

The study compared the combination therapy against Keytruda alone, a standard checkpoint inhibitor. While the combination showed no statistical advantage in delaying disease progression, the trial’s other primary endpoint – overall survival – remains unevaluated due to immature data.

An independent data monitoring committee advised that the trial continue as planned to collect overall survival outcomes, offering a potential path for the vaccine to demonstrate benefit later.

Analysts had previously lifted BioNTech’s share price on optimism from related mRNA oncology data, but the missed endpoint has tempered confidence, highlighting the challenges of translating early promise into definitive clinical success.