Updated version 1-BioNTech's mRNA cancer therapy fails to meet first endpoint in head and neck clinical trial

Updated stock price movements; details and analyst comments added in items 5 and 6

Reuters, October 13 - BioNTech (22UAy.DE) said on Tuesday that its experimental mRNA cancer immunotherapy for head and neck cancer patients failed to meet the primary endpoint in its mid- to late-stage clinical trial.

The drug developer's US-listed shares fell nearly 3% in early trading.

• The trial tested the drug BNT113 in combination with Merck & Co's MRK.N blockbuster cancer drug Keytruda (chemical name: pembrolizumab) for treating patients with advanced head and neck squamous cell carcinoma (HNSCC) associated with the HPV16 virus.

• Compared to using Keytruda alone, the combination therapy did not show a statistically significant improvement in progression-free survival (PFS), a measure of the length of time that patients live without their disease worsening.

• Citi analyst Geoffrey Meacham said, “While the results are disappointing, head and neck squamous cell carcinoma (HNSCC) is heterogeneous and characterized by severe immunosuppression, making it challenging to achieve greater efficacy than pembrolizumab—even when targeting the HPV16 virus.”

• BioNTech stated that it would continue the trial in accordance with the recommendation of the independent data monitoring committee, in order to assess the second primary endpoint—overall survival (OS)—to determine whether the therapy can help prolong patients’ lives.

• Overall survival is generally considered the “gold standard” in cancer research. In the past, some cancer immunotherapies have gained regulatory approval after achieving the overall survival (OS) endpoint despite missing the progression-free survival (PFS) target.

• “Even if the PFS endpoint is not achieved, a statistically significant OS benefit can still establish the trial outcome as positive,” Meacham added.

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