BioNTech's mRNA cancer therapy misses first goal in head and neck trial

Merck & Co

13/10/2026 13:13

Oct 13 (Reuters) - BioNTech 22UAy.DE said on Tuesday its experimental mRNA cancer immunotherapy failed to meet the first main goal of a mid-to-late-stage trial in patients with head and neck cancer.
US-listed shares of the drug developer were down nearly 6% in premarket trading. 
The trial tested the drug, BNT113, combined with Merck's MRK.N blockbuster cancer drug Keytruda in patients with advanced head and neck squamous cell carcinoma (HNSCC) linked to the HPV16 virus  
The combination did not show a statistically significant improvement in progression-free survival, which measures the time a patient lives without their disease worsening, when compared against treatment with Keytruda alone
"While disappointing, HNSCC is heterogeneous and heavily immunosuppressed, making incremental efficacy over pembrolizumab challenging despite the HPV16 target," said Citi analyst Geoffrey Meacham
BioNTech said the trial would continue to evaluate its second main goal of overall survival to assess whether the therapy helps patients live longer
An independent data monitoring committee recommended that the study proceed as planned, the company said
"While the PFS result was not statistically significant at this first analysis, the data support continued evaluation of BNT113 plus pembrolizumab in this trial and show that it is engaging its intended therapeutic mechanism," said Özlem Türeci, chief medical officer at BioNTech. Keytruda is known chemically as pembrolizumab 

(Reporting by Kamal Choudhury in Bengaluru; Editing by Jonathan Ananda)
((Kamal.Choudhury@thomsonreuters.com;))