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StocksMediumUpdated×2•Originally published 14 September 2026•Updated 14 September 2026•
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BioNTech Rises as Gotistobart Median Survival Reaches 18.5 Months Versus 10.0 Months

Orange digital illustration of BioNTech headquarters, DNA helix, medical equipment, and a survival rate line chart.

Key Facts

1Median overall survival was 18.5 months with gotistobart versus 10.0 months with docetaxel.
2The Stage 1 analysis included 87 patients: 45 on gotistobart and 42 on docetaxel.
3The hazard ratio was 0.56 with a nominal p-value of 0.0295 after median follow-up of 25.4 months.
4Grade 3 or higher treatment-related adverse events were 44.4% with gotistobart versus 48.8% with docetaxel.

BioNTech shares rose 5.6% in pre-open trading on September 14 after the company and partner OncoC4 announced updated gotistobart data. Median overall survival was 18.5 months among patients receiving the drug, compared with 10.0 months for those receiving docetaxel chemotherapy.

The findings came from the non-pivotal Stage 1 portion of the randomized Phase 3 PRESERVE-003 trial. The analysis covered 87 patients with metastatic squamous non-small cell lung cancer whose disease had progressed after prior immunotherapy and chemotherapy; 45 received gotistobart and 42 received docetaxel.

At the July 17, 2026 data cutoff, median follow-up was 25.4 months and the survival comparison produced a hazard ratio of 0.56 with a nominal p-value of 0.0295. A hazard ratio describes the relative difference in the risk of death during follow-up, not an absolute survival probability; the nearly doubled description refers to the 18.5-month and 10.0-month median survival figures.

Grade 3 or higher treatment-related adverse events occurred in 20 of 45 patients, or 44.4%, in the gotistobart group and 20 of 42, or 48.8%, in the docetaxel group. The company described the safety profile as manageable, but the Stage 1 sample alone does not establish equivalent safety between the treatments.

Gotistobart, also known as BNT316 or ONC-392, is an investigational CTLA-4-targeting immunotherapy designed to enhance regulatory T-cell depletion within the tumor microenvironment. PRESERVE-003 compares gotistobart monotherapy with docetaxel in patients whose disease progressed after PD-(L)1 inhibitors and platinum-based chemotherapy.

The pivotal Stage 2 portion of PRESERVE-003 remains ongoing at more than 160 sites globally. Overall survival is the primary endpoint, while secondary endpoints include overall response rate, progression-free survival and safety; confirmation in this portion remains the key development before drawing regulatory or commercial conclusions.