BioNTech sticks with cancer vaccine despite trial miss
BioNTech's headquarters in Mainz, Germany.
A phase 2/3 trial of BioNTech's immunotherapy for head and neck cancer, BNT113, has failed to meet its objective, but the company has said it will let the study play out.
Adding BNT113 to standard first-line treatment with MSD's PD-1 inhibitor Keytruda (pembrolizumab) for head and neck squamous cell carcinoma (HNSCC) that expresses the PD-L1 biomarker and tests positive for HPV16 did not extend the time to disease progression or death compared to Keytruda alone in the AHEAD-MERIT trial.
Also known as tenumomeran/raplemomeran or tenu-ra, BNT113 is an intravenously administered, off-the-shelf mRNA-based cancer vaccine that codes for two HPV16 oncoproteins – E6 and E7 – and is designed to activate an anti-tumour immune response. Approximately one third of HNSCC cases are associated with HPV infection, and most are linked to HPV16, one of the most common, high-risk HPV types associated with cancer.
While the progression-free survival (PFS) result is a big disappointment, BioNTech said that it will continue the study until it reaches its second main endpoint, overall survival (OS), on the recommendation of the study's independent data monitoring committee.
According to the company, the design of the study means that if BNT113 is associated with an improvement in OS, it would "establish a positive trial outcome, even if the PFS dual primary endpoint was not met."
Cancer immunotherapies are a major focus for BioNTech as it navigates the reduced market for its mRNA vaccines for infectious diseases, which drove the German biotech's explosive growth during and after the COVID-19 pandemic.
The BNT113 is leading BioNTech's off-the-shelf cancer immunotherapies, marginally ahead of BNT111 for advanced/relapsed-refractory melanoma and BNT116 for advanced non-small cell lung cancer (NSCLC).
It has a parallel track focused on individualised vaccines – tailored to patient-specific tumour mutations – which is currently led by Roche/Genentech-partnered BNT122 (autogene cevumeran), in phase 2 testing for adjuvant colorectal cancer, pancreatic ductal adenocarcinoma (PDAC), and other solid tumours.
"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, BioNTech's co-founder and chief medical officer, who is due to leave the company along with fellow co-founder and CEO Uğur Şahin at the end of the year.
"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."
Shares in BioNTech were trading down nearly 6% at the time of writing.
