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

Oct 13 — BioNTech 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 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)

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