BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer
Key Highlights
- ➤BNT113 plus pembrolizumab fails first dual primary endpoint of statistically significant PFS improvement
- ➤AHEAD-MERIT continues evaluating overall survival as its second dual primary endpoint
- ➤Statistically significant overall survival improvement could establish a positive trial outcome
- ➤BNT113 received FDA Fast Track Designation in January 2026
Expert Statements
Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech
“The potential of mRNA cancer immunotherapies in combination regimen lies in their ability to induce immune responses that may translate into durable clinical benefit and, ultimately, prolonged survival of patients. While the PFS result was not statistically significant at this first analysis, the data support continued evaluation of BNT113 plus pembrolizumab in this trial and show that it is engaging its intended therapeutic mechanism.”
Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech
“As immune-mediated anti-tumor effects build and deepen over time, the analysis of the second dual primary endpoint, overall survival, will be critical to fully assess the potential of this approach to deliver durable benefit for patients with HPV-driven head and neck cancer.”
* AHEAD-MERIT Phase 2/3 clinical trial did not meet its first dual primary endpoint of progression-free survival for the mRNA cancer immunotherapy candidate BNT113 plus pembrolizumab compared with pembrolizumab alone * The trial will continue to evaluate the second dual primary endpoint of overall survival completing the assessment with the potential of this treatment approach to help patients live longer * Under the trial’s pre-specified statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome, even if the progression-free survival dual primary endpoint was not met * mRNA cancer immunotherapies are a key pillar of BioNTech’s oncology strategy, which includes novel treatment combinations to maximize the potential of its diversified oncology pipeline and elevate treatment outcomes for patients MAINZ, Germany, October 13, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) for its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran or “tenu-ra”).
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