BioNTech and OncoC4 have reported the initial median overall survival (OS) results from the PRESERVE-003 Phase III trial’s non-pivotal stage 1, which evaluated gotistobart (BNT316 or ONC-392) for squamous non-small cell lung cancer (NSCLC).
This trial showed that the treatment was associated with a statistically significant increase in OS for patients with previously treated NSCLC compared with standard chemotherapy.
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The data from the global randomised trial were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).
In stage I of the trial, 87 patients with metastatic squamous NSCLC whose cancer had progressed after immunotherapy and chemotherapy were randomised to two groups.
One group received gotistobart monotherapy (6mg/kg with two 10mg/kg loading doses, N=45) and the other received docetaxel 75mg/m² (N=42) as a second-line or later option.
At the data cut-off of 17 July 2026 and a median follow-up of 25.4 months, median overall survival was 18.5 months with gotistobart versus 10.0 months in the docetaxel group.
The hazard ratio reached 0.56 with a nominal p-value of 0.0295, according to the trial sponsors.
Adverse events of grade 3 or higher were reported in 44.4% of the gotistobart group and 48.8% of those given docetaxel. The companies stated that the safety findings matched previous observations and remained manageable in the context of the study.
BioNTech co-founder and chief medical officer Özlem Türeci said: “These data underscore gotistobart’s potential to redefine treatment for patients with hard-to-treat squamous NSCLC whose disease has progressed after initial therapy and who face limited options.
“In second- and later lines of treatment, the clinical relevance of novel therapeutic options depends on the ability to re-engage a suppressed or exhausted anti-tumour immune response and overcome acquired resistance.
“This update highlights gotistobart’s unique mode of action and our ambition to translate our deep understanding of the immune system into meaningful survival benefit for patients with lung cancer—particularly in areas where patients still need more.”
The pivotal stage 2 of the PRESERVE-003 trial is ongoing at over 160 global sites. Gotistobart, an investigational CTLA-4-targeting immunotherapy, is being jointly developed by BioNTech and OncoC4.
