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BioNTech’s BNT113 fails to improve survival in trial

By Drooid · Oct 14, 2026, 3:42 PM UTC · How we work

Summary

BioNTech BNT113 Fails

BioNTech's BNT113 failed to improve progression-free survival in the HPV head and neck cancer trial.
The AHEAD-MERIT study enrolled 358 PD-L1-positive, unresectable or metastatic HPV16-positive head and neck squamous cell carcinoma patients.
BNT113 was combined with Merck's Keytruda and compared with Keytruda alone as first-line therapy.
BioNTech shares dropped about 5%–6% in early trading after the topline results were disclosed.

Summary

BioNTech Gains Fast-Track

BNT113 received U.S. FDA Fast Track designation in January 2026, accelerating its development.
The AHEAD-MERIT trial enrolls patients with PD-L1 CPS >= 1 for up to roughly 24 months.
Part A of the study is a non-randomized safety run-in before randomization.
Secondary endpoints include objective response rate, duration of response and safety.
Inhibrx reported a 48.3% response rate with its OX40 agonist plus pembrolizumab in a Phase II HNSCC study.

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BioNTech BNT113 Fails

BioNTech's BNT113 failed to improve progression-free survival in the HPV head and neck cancer trial.
The AHEAD-MERIT study enrolled 358 PD-L1-positive, unresectable or metastatic HPV16-positive head and neck squamous cell carcinoma patients.
BNT113 was combined with Merck's Keytruda and compared with Keytruda alone as first-line therapy.
BioNTech shares dropped about 5%–6% in early trading after the topline results were disclosed.

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