BioNTech Reports Lung Cancer Trial Survival Data

BioNTech and OncoC4 presented updated survival data from stage 1 of their randomized Phase 3 PRESERVE-003 clinical trial evaluating gotistobart. The investigational immunotherapy was tested as a monotherapy in patients with metastatic squamous non-small cell lung cancer whose disease progressed after prior chemotherapy and immunotherapy.

At a data cut-off on 17 July 2026, with a median follow-up of 25.4 months across 87 patients, gotistobart demonstrated a median overall survival of 18.5 months. In comparison, patients receiving the standard-of-care chemotherapy docetaxel recorded a median overall survival of 10.0 months. The trial showed a hazard ratio of 0.56 with a nominal p-value of 0.0295.

Treatment-related adverse events of grade 3 or higher occurred in 20 of 45 patients receiving gotistobart, representing 44.4%, compared to 20 of 42 patients receiving docetaxel, representing 48.8%. The companies presented these results at the IASLC 2026 World Conference on Lung Cancer.

The pivotal stage 2 portion of the PRESERVE-003 study is active across more than 160 sites globally. The drug candidate previously received Fast Track designation from the US Food and Drug Administration in 2022 and Orphan Drug designation in 2025, alongside Breakthrough Therapy designation in China in 2025.