On October 13, BioNTech announced that, in a trial of BNT113 in HPV16-positive head and neck cancer, the combination with pembrolizumab did not demonstrate statistically significant superiority in progression-free survival over pembrolizumab alone. BNT113 is an mRNA product designed to stimulate immune responses against antigens derived from HPV16.

Evaluation of overall survival, specified from the outset as the other primary endpoint, will continue. This is not a change of endpoint made after seeing the result. Detailed data have not yet been disclosed, so it is too early to explain why the combination did not succeed on this endpoint. Our article on combination development ↗ should accumulate actual outcomes, not just expectations. BioNTech announcement ↗

NEXT CHECK AT PUBLICATION

The planned OS analysis, detailed PFS results, and explanations of the population and safety findings.

See the topic’s current state and history →

Evidence & reading

Public sources checked for this edition. Linked pages may subsequently change.

  1. BNT113 AHEAD-MERIT Phase 2/3 trial update ↗BioNTech · 2026-10-13

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