BioNTech mRNA cancer therapy fails primary trial goal

BioNTech reported that its experimental mRNA cancer immunotherapy, BNT113, failed to meet the primary goal of a mid-to-late-stage clinical trial. The study evaluated the drug in combination with Merck’s Keytruda for patients with advanced head and neck squamous cell carcinoma linked to the HPV16 virus.

The combination therapy did not demonstrate a statistically significant improvement in progression-free survival (PFS) compared to treatment with Keytruda alone. Following the announcement, BioNTech’s US-listed shares declined by nearly 3% in early trading.

Despite the setback, the trial will continue as recommended by an independent data monitoring committee. Researchers will focus on the second main goal: overall survival (OS). Achieving a statistically significant OS benefit could still lead to a positive trial outcome and potential regulatory approval.