BioNTech Continues AHEAD-MERIT Trial Despite BNT113's PFS Endpoint Miss

(RTTNews) - BioNTech SE (BNTX) announced that its Phase 2/3 AHEAD-MERIT trial evaluating BNT113 in combination with pembrolizumab did not meet the primary endpoint of progression-free survival (PFS) compared with pembrolizumab alone in patients with HPV16-positive head and neck cancer.

The trial is continuing to evaluate overall survival (OS), its second primary endpoint, following a recommendation from the Independent Data Monitoring Committee. Under the trial's statistical design, a significant improvement in overall survival could still establish a positive outcome.

BNT113 is an investigational mRNA cancer immunotherapy designed to target HPV16-derived E6 and E7 antigens frequently expressed in tumor cells. The candidate is being studied as a first-line treatment for patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma.

BioNTech said the overall survival analysis will help determine the potential of BNT113 combined with pembrolizumab to improve long-term outcomes. BNT113 received Fast Track Designation from the U.S. Food and Drug Administration in January 2026.

The stock closed Monday's trade at $95.84, down 1.16%.In the Pre market trading, BNTX is down 4.01% at $92.00.