Kelly Cloonan

BioNTech said its cancer immunotherapy BNT113 didn't meet the first dual primary endpoint of progression-free survival in a recent phase 2/3 trial.

The company on Tuesday said the drug, in combination with pembrolizumab, didn't demonstrate a statistically significant improvement in progression-free survival versus pembrolizumab alone in the phase 3 part of the trial.

The study's independent data monitoring committee recommended that the clinical trial continues as planned to evaluate the trial's second primary endpoint of overall survival, BioNTech said.

Under the trial's design, a statistically significant improvement in overall survival would mark a positive trial outcome, even if it didn't meet its first dual primary endpoint, BioNTech said.

The trial is evaluating BNT113 in combination with pembrolizumab as a treatment for patients with certain types of HPV-driven head and neck cancer.