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

Merck & Co

13/10/2026 14:41

Updates share movement, adds details and analyst comment in bullets 5 and 6
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 3% in early trading. 
The trial tested the drug, BNT113, combined with Merck's MRK.N blockbuster cancer drug Keytruda, chemically known as pembrolizumab, 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 (PFS), 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 as recommended by an independent data monitoring committee to evaluate its second main goal of overall survival (OS) to assess whether the therapy helps patients live longer
Overall survival is generally considered the gold standard measure in cancer studies, and previous cancer immunotherapies have won regulatory approvals after missing PFS targets but succeeding on OS goals
"A statistically significant OS benefit would establish a positive trial outcome despite the PFS miss," Meacham added

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