BioNTech’s BNT113 Trial Misses Progression-Free Survival Endpoint in HPV-Driven Head and Neck Cancer

On Oct 13, BioNTech announced that its experimental mRNA cancer immunotherapy BNT113, combined with Merck’s pembrolizumab (Keytruda), failed to achieve a statistically significant improvement in progression-free survival (PFS) versus pembrolizumab alone. The topline analysis comes from the Phase 2/3 AHEAD-MERIT trial, which enrolled 358 patients with unresectable, recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) expressing PD-L1. While the PFS goal was not met, the independent data monitoring committee (IDMC) recommended that the trial continue to evaluate overall survival (OS), the second primary endpoint.

BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer BioNTech Shares Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy in Metastatic HPV16-Positive HNC BioNTech's BNT113 misses Phase III PFS endpoint in head and neck cancer, OS analysis continues BioNTech Shares Slide After mRNA Cancer Therapy Misses Progression-Free Survival Goal in Head and Neck Trial — BigGo Finance ReutersBioNTech’s mRNA cancer vaccine misses Phase 2/3 endpoint

BNT113 is an “off-the-shelf” vaccine encoding the HPV16 oncoproteins E6 and E7, designed to boost the immune response triggered by pembrolizumab’s checkpoint inhibition. Approximately one-third of HNSCC cases are linked to HPV infection, predominantly HPV16, and no HPV-targeted therapy is currently approved. The miss follows earlier setbacks in BioNTech’s pipeline, including the discontinuation of autogene cevumeran (BNT122) trials in bladder and colorectal cancers.

PharmaphorumBioNTech Shares Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy in Metastatic HPV16-Positive HNC BioNTech's BNT113 misses Phase III PFS endpoint in head and neck cancer, OS analysis continues BioSpaceBioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer

• Patients enrolled: 358

Medical Daily

• Trial design: Open-label, two-arm Phase 2/3 (Part A safety run-in; Part B randomized efficacy)

BioSpace

• Primary endpoints: PFS and OS

BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer

• Result: No statistically significant improvement in PFS for the BNT113 + pembrolizumab arm versus pembrolizumab alone. Detailed PFS figures and safety data have not been released.

BioNTech's BNT113 misses Phase III PFS endpoint in head and neck cancer, OS analysis continues

BioNTech’s press release said the combination “engages its intended therapeutic mechanism” and noted that the IDMC’s recommendation reflects the trial’s prespecified design, which allows a positive outcome if OS shows a significant benefit. The company remains blinded to OS data and will continue per protocol.

BioNTech Shares Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy in Metastatic HPV16-Positive HNC

If BNT113 eventually demonstrates an OS advantage, it would become the first approved HPV-targeted therapy for head and neck cancer, addressing an unmet need. The outcome also influences BioNTech’s broader mRNA oncology portfolio and market perception as the firm shifts focus from COVID-19 vaccines to cancer treatments. BioNTech shares fell 5-6% in early trading after the announcement.

Medical Daily

Publicly available information does not include the exact magnitude of the PFS difference, safety outcomes, or the timeline for the final OS analysis. The results have not been peer-reviewed or presented at a medical conference.

BioNTech Shares Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy in Metastatic HPV16-Positive HNC

The trial will continue to collect OS data until the pre-specified analysis is completed. No specific date for the OS readout has been disclosed. BioNTech will update the medical community once the final survival results are available.

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• “While disappointing, HNSCC is heterogeneous and heavily immunosuppressed, making incremental efficacy over pembrolizumab challenging despite the HPV16 target,” — Citi

Reuters

• “A statistically significant OS benefit would establish a positive trial outcome despite the PFS miss,” — Geoffrey Meacham, Citi analyst

Reuters