Gotistobart (BNT316/ONC-392) Extends Median OS to 18.5 Months vs Docetaxel in Stage 1 PRESERVE-003 Phase III Results

BioNTech and OncoC4 have reported initial results from the non-pivotal stage 1 of the PRESERVE-003 Phase III trial evaluating gotistobart (BNT316, ONC-392) in metastatic squamous non-small cell lung cancer (NSCLC). The data, presented at the IASLC 2026 World Conference on Lung Cancer (WCLC), show a statistically significant overall survival (OS) benefit for gotistobart compared with standard chemotherapy in patients whose disease progressed after prior immunotherapy and platinum-based chemotherapy.

Trial Design and Primary Results

Stage 1 enrolled 87 patients with metastatic squamous NSCLC and prior progression on immunotherapy and chemotherapy. Patients were randomised to gotistobart monotherapy (6 mg/kg with two 10 mg/kg loading doses; N = 45) or docetaxel 75 mg/m2 (N = 42) as a second-line or later therapy.

At the data cut-off of 17 July 2026, with a median follow-up of 25.4 months, median overall survival was 18.5 months in the gotistobart arm versus 10.0 months in the docetaxel arm (hazard ratio 0.56; nominal p = 0.0295), according to the trial sponsors.

Safety

Grade 3 or higher adverse events occurred in 44.4% of patients treated with gotistobart and 48.8% of those receiving docetaxel. The companies reported that safety findings were consistent with prior observations and remained manageable within the clinical-trial setting.

Özlem Türeci, Co-founder and Chief Medical Officer, BioNTech: "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-line settings, clinical relevance depends on re-engaging a suppressed or exhausted anti-tumour immune response and overcoming 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."

Drug Profile and Next Steps

Gotistobart is an investigational CTLA-4–targeting immunotherapy being co-developed by BioNTech and OncoC4. The pivotal, randomised stage 2 of PRESERVE-003 is ongoing across more than 160 sites worldwide; results from stage 2 will be needed to confirm the stage 1 findings and support potential regulatory submissions.

Notes: This report standardises the trial name as PRESERVE-003 (the original release contained an inconsistent reference). The stage 1 results reported here are non-pivotal and should be interpreted in that context until confirmed by the ongoing pivotal stage 2.