BioNTech's BNT113 Misses PFS Endpoint in Phase 2/3 Head and Neck Cancer Trial
BNTX sits 15% above its 52-week low of $79.52.
Summary
On October 13, 2026, BioNTech announced that BNT113, also known as tenumomeran/raplemomeran or “tenu-ra”, its mRNA cancer immunotherapy for HPV16-positive head and neck cancer, failed to show a statistically significant improvement in progression-free survival (PFS) when combined with pembrolizumab versus pembrolizumab alone in the Phase 2/3 AHEAD-MERIT trial (NCT04534205). The Independent Data Monitoring Committee recommended the trial continue to evaluate the second primary endpoint, overall survival (OS), which could still yield a positive outcome under the pre-specified statistical design. The trial is for first-line treatment of unresectable recurrent or metastatic HNSCC in patients expressing PD-L1 with a combined positive score (CPS) ≥1, and BNT113 encodes E6 and E7 proteins of HPV16 to induce HPV16-specific anti-tumor immune responses. Patients are treated for up to approximately 24 months, and secondary endpoints include safety, objective response rate (ORR), and duration of response (DoR). AHEAD-MERIT is an open-label, controlled, multi-site, interventional, 2-arm, Phase 2/3 trial with Part A as an initial non-randomized Safety Run-In Phase to confirm safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab, and Part B as a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. This is a setback for BioNTech's oncology pipeline, which has already seen the termination of its autogene cevumeran colorectal cancer trial in August and a guidance cut earlier this year. The company remains blinded to ongoing data, and the OS readout will be the next critical catalyst for this program. No specific timeline for the OS analysis was provided.
Updated with an SEC 6-K filing · What changed
Updates
· SEC 6-K — On October 13, 2026, BioNTech announced the AHEAD-MERIT trial did not meet its progression-free survival endpoint for BNT113 plus pembrolizumab versus pembrolizumab alone, but will continue to evaluate overall survival.
- Trial Design — The trial is for first-line treatment of unresectable recurrent or metastatic HNSCC in patients expressing PD-L1 with CPS ≥1. It is an open-label, controlled, multi-site, interventional, 2-arm, Phase 2/3 trial with a non-randomized Safety Run-In Phase (Part A) and a randomized Part B.
- Mechanism — BNT113 encodes E6 and E7 proteins of HPV16 to induce HPV16-specific anti-tumor immune responses.
- Treatment Duration — Patients are treated for up to approximately 24 months.
- Secondary Endpoints — Secondary endpoints include safety, objective response rate (ORR), and duration of response (DoR).
All 9 details
- BNT113 is also known as tenumomeran/raplemomeran or “tenu-ra”.
- The AHEAD-MERIT trial's NCT number is NCT04534205.
- The trial is for first-line treatment of unresectable recurrent or metastatic HNSCC.
- Patients must express PD-L1 with a combined positive score (CPS) ≥1.
- BNT113 encodes E6 and E7 proteins of HPV16 to induce HPV16-specific anti-tumor immune responses.
- Patients are treated for up to approximately 24 months.
- Secondary endpoints include safety, objective response rate (ORR), and duration of response (DoR).
- AHEAD-MERIT is an open-label, controlled, multi-site, interventional, 2-arm, Phase 2/3 trial.
- Part A is an initial non-randomized Safety Run-In Phase to confirm safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab; Part B is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1.
At the time of this announcement, BNTX was trading at $91.84 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $24.1B. The 52-week trading range was $79.52 to $124.00. This news item was assessed with negative market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.