BioNTech mRNA头颈癌疫苗BNT113三期AHEAD-MERIT未达PFS主要终点，OS仍待读出

BioNTech SE (BNTX) announced that its AHEAD-MERIT Phase 2/3 trial evaluating BNT113 in combination with pembrolizumab did not meet the primary endpoint of progression-free survival (PFS) compared with pembrolizumab alone in patients with HPV16-positive head and neck cancer.
The AHEAD-MERIT trial is evaluating BNT113 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.
The Phase 3 portion of the trial has two primary endpoints: PFS and overall survival (OS).
Although the trial did not demonstrate a statistically significant improvement in PFS, the Independent Data Monitoring Committee recommended that the study continue as planned to evaluate overall survival.
Under the trial's prespecified statistical design, a statistically significant improvement in OS could establish a positive trial outcome despite the PFS result.
BNT113, also known as tenumomeran/raplemomeran, is an investigational mRNA cancer immunotherapy designed to target the HPV16-derived E6 and E7 antigens frequently expressed in HPV16-positive tumor cells.
The treatment aims to induce HPV16-specific antitumor immune responses when combined with standard checkpoint inhibitor therapy.
BioNTech said the overall survival analysis will be important in determining whether the combination can provide durable clinical benefits and help patients live longer. The company remains blinded to ongoing trial data in accordance with the study's governance procedures.
HPV16-positive HNSCC represents a subset of head and neck cancers, and treatment options remain limited for patients with recurrent or metastatic disease. BNT113 received Fast Track Designation from the U.S. Food and Drug Administration in January 2026.
Company Statement
BioNTech said the potential of mRNA cancer immunotherapies in combination regimens lies in their ability to induce immune responses that may translate into durable clinical benefits and prolonged survival.
The company emphasized that the ongoing OS assessment will help determine the treatment's potential in HPV-driven head and neck cancer.
Stock performance
BNTX has traded between $79.52 and $124.00 over the last year. The stock closed Monday's trade at $95.84, down 1.16%.
In the pre-market trading, SBNTX is further down 6.08% to $90.01.
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