BioNTech’s experimental mRNA immunotherapy BNT113, tested alongside Keytruda, failed to delay tumor progression in a late-stage study of head and neck squamous cell carcinoma driven by a high-risk strain of HPV. At an interim data check, the combination did not extend progression-free survival compared with Keytruda alone as a first-line treatment, the company said Tuesday.
The trial is continuing, however. A data monitoring committee encouraged BioNTech to keep testing whether the regimen can meet the study’s other main goal by extending overall survival. BioNTech co-founder and Chief Medical Officer Özlem Türeci said the early results support continued evaluation and show the drug combination is engaging its intended therapeutic mechanism. Still, analysts had been skeptical: Leerink Partners’ Daina Graybosch noted earlier that evidence supporting BNT113’s activity in head and neck cancer was sparse when the Phase 3 study began, and the trial enrolled patients with lower levels of PD-L1.
The miss is the latest mixed result for BioNTech as it pivots from COVID-19 vaccines back to oncology. The company also reported a study setback in colorectal cancer earlier this year, and it is increasingly relying on its bispecific cancer drug pumitamig, developed with Bristol Myers Squibb. BioNTech shares fell about 6% in early trading Tuesday.