Disappointing preliminary result: BioNTech's cancer immunotherapy trial awaits its second test

German company BioNTech announced that its experimental immunotherapy "BNT113" did not achieve a statistically significant improvement in delaying head and neck cancer progression when added to the drug pembrolizumab, compared to using the drug alone. However, the trial will continue to evaluate whether the combination therapy helps patients live longer.

German company BioNTech announced that its experimental immunotherapy "BNT113" did not achieve a statistically significant improvement in delaying head and neck cancer progression when added to the drug pembrolizumab (known commercially as Keytruda), compared to using the drug alone. The therapy targets two proteins associated with human papillomavirus type 16. The mentioned result relates to one of the two primary endpoints predefined for the study, which is progression-free survival. The other endpoint, overall survival, has not yet been determined; therefore, the announcement does not constitute proof of therapeutic benefit, nor does it alone decide the final outcome of the trial. The study included patients with advanced squamous cell carcinoma of the head and neck associated with human papillomavirus type 16, who have recurrent cancer that cannot be surgically removed or is metastatic, with specific biomarkers present in the tumor. An independent data monitoring committee recommended continuing follow-up as planned. According to the announced statistical design, the trial could achieve a positive result if it later shows a statistically significant improvement in overall survival.