FAILED TRIAL: AHEAD-MERIT Ph 2/3 trial did not meet first dual primary endpoint of PFS for BNT113 + pembrolizumab vs pembrolizumab in HPV16+ HNSCC patients
“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,” said Prof. Özlem Türeci, M.D., 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.”
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