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StocksMediumUpdated•Originally published 14 September 2026•Updated 14 September 2026•
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BioNTech’s Gotistobart Cuts Death Risk 54% in Exploratory Phase 3 Stage

Key Facts

1Gotistobart was associated with a 54% lower risk of death than docetaxel in exploratory Stage 1.
2The analysis included 87 patients: 45 on gotistobart and 42 on docetaxel.
3At 12 months, survival was 63.1% with gotistobart versus 30.3% with docetaxel.
4Pivotal Stage 2 remains ongoing and plans to enroll about 500 patients at more than 160 sites.

Gotistobart, developed by BioNTech with OncoC4, showed a clinically meaningful overall-survival benefit over docetaxel in patients with metastatic squamous non-small cell lung cancer whose disease had progressed after immunotherapy and platinum chemotherapy. The finding came from the non-pivotal Stage 1 portion of the two-stage global Phase 3 PRESERVE-003 trial.

The analysis included 87 patients: 45 received gotistobart and 42 received docetaxel. After a median follow-up of 14.5 months, gotistobart was associated with a 54% lower risk of death, with a hazard ratio of 0.46 and a nominal P value of 0.0102. Median overall survival was not estimable with gotistobart, compared with 10.0 months for docetaxel.

The overall-survival rate after 12 months was 63.1% with gotistobart versus 30.3% with docetaxel. Grade 3 or higher treatment-related adverse events occurred in 42.2% of gotistobart recipients and 48.8% of docetaxel recipients, according to BioNTech.

The figures require caution: Stage 1 was exploratory and was not statistically powered to demonstrate efficacy, while pivotal Stage 2 remains underway. That stage plans to enroll about 500 patients across more than 160 sites, making its outcome more consequential for the development and regulatory path than the early signal.

Gotistobart is a CTLA-4-targeting antibody designed to deplete regulatory T cells within the tumor microenvironment. The U.S. Food and Drug Administration granted the program Fast Track status in 2022 and Orphan Drug Designation for squamous non-small cell lung cancer on January 12, 2026; neither designation amounts to marketing approval.

BioNTech scheduled an updated follow-up of the Stage 1 data for presentation at the World Conference on Lung Cancer on September 14, 2026. In its August 4 update, the company said the first interim analysis from pivotal Stage 2 was expected during 2026, making that the next major clinical catalyst for investors.