BioNTech’s mRNA immunotherapy fails to meet primary endpoint
BioNTech has announced the first topline results from the AHEAD-MERIT Phase II/III clinical trial for its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran or tenu-ra).
The clinical trial is evaluating BNT113 in combination with pembrolizumab compared to pembrolizumab monotherapy as a first-line treatment for patients with unresectable recurrent or metastatic human papillomavirus 16-positive (HPV16+) head and neck squamous cell carcinoma (HNSCC) expressing PD-L1.
Approximately one third of HNSCC cases are associated with HPV infection, with the majority linked to HPV16.
The Phase III part of AHEAD-MERIT has dual primary endpoints, progression-free survival (PFS) and overall survival (OS), providing complementary measures of clinical benefit.
At the analysis for PFS, BNT113 in combination with pembrolizumab did not demonstrate a statistically significant improvement in PFS versus pembrolizumab alone.
The Independent Data Monitoring Committee (IDMC) has recommended that the clinical trial continues as planned to evaluate the second primary endpoint of OS.
Under the trial’s pre-specified statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome, even if the PFS dual primary endpoint was not met.
“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 Professor Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech.
“As immune-mediated anti-tumour 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.”