BioNTech's BNT113 misses PFS endpoint in Phase 2/3 head and neck cancer trial

What's the story? BioNTech announced on 13 October 2026 that its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran) did not meet the first dual primary endpoint of progression-free survival (PFS) in the AHEAD-MERIT Phase 2/3 trial. The study compared BNT113 plus pembrolizumab (Keytruda) against pembrolizumab alone as a first-line treatment for adults with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.

Why it matters: The independent data monitoring committee recommended the trial continue as planned to evaluate the second dual primary endpoint, overall survival (OS). Under the trial's pre-specified statistical design, a statistically significant improvement in OS would still establish a positive trial outcome even though the PFS endpoint was missed. BNT113 is an mRNA vaccine designed to train the immune system against the E6 and E7 viral proteins found on HPV16-driven tumours, aiming to boost responses to checkpoint inhibitor therapy. About one third of head and neck squamous cell carcinoma cases are linked to HPV infection, and the majority of those to HPV16 — yet no HPV-targeted treatment is currently approved. BNT113 received US FDA fast track designation in January 2026. mRNA cancer immunotherapies remain a key pillar of BioNTech's oncology strategy, alongside antibody-drug conjugates and bispecifics.

Read more: BioNTech, 13 Oct 2026