BioNTech's gotistobart shows 18.5-month median survival in relapsed squamous lung cancer, beating docetaxel

BioNTech presented updated data from its phase 3 Preserve-003 trial at the World Conference on Lung Cancer in Seoul. The trial compares its anti-CTLA-4 antibody gotistobart with standard chemotherapy docetaxel in patients with metastatic squamous non-small cell lung cancer who have no actionable genomic alterations.

In the first stage of the study, the median overall survival for patients receiving gotistobart was 18.5 months, compared with 10 months for those on docetaxel, confirming a substantial survival advantage.

The earlier analysis had shown an immature survival signal; the new data strengthen the case for gotistobart as a potential new standard of care if the benefit is confirmed in the trial’s second stage.

BioNTech’s co-founder and outgoing chief medical officer Özlem Türeci said the results underscore the drug’s potential to redefine treatment for this hard-to-treat cancer type.