BNT113 head and neck cancer trial misses first endpoint

The BNT113 head and neck cancer trial did not meet its first dual primary endpoint. BioNTech reported on 13 October 2026 that the Phase 2/3 AHEAD-MERIT study found no statistically significant improvement in progression-free survival when BNT113 was added to pembrolizumab, compared with pembrolizumab alone, in patients with HPV16-positive head and neck squamous cell carcinoma.

The BNT113 head and neck cancer trial continues

The Independent Data Monitoring Committee recommended that the study carry on to the second primary endpoint, overall survival. Under the pre-specified design, a statistically significant gain in overall survival would still count as a positive outcome. BioNTech says it remains blinded to ongoing trial data.

BNT113 is an mRNA cancer immunotherapy that encodes the E6 and E7 proteins of HPV16. It received FDA Fast Track designation in January 2026. BioNTech’s chief medical officer, Özlem Türeci, said the data show the candidate “is engaging its intended therapeutic mechanism”, while adding that overall survival will be critical to judge its potential.

Why it matters

For patients whose disease progresses on current standard of care, the missed progression-free survival endpoint is a setback for this approach. The trial itself is still running. Accurate HPV status shapes prognosis and treatment choices, as our coverage of HPV testing in head and neck squamous cell carcinoma explains. Readers following combination immunotherapy in this setting can also see our earlier piece on neoadjuvant immunotherapy in head and neck cancer.

Source: BioNTech press release, 13 October 2026