BioNTech and OncoC4 have announced the first median Overall Survival (OS) data from the non-pivotal stage 1 of the global randomised PRESERVE-003 phase 3 clinical trial (NCT05671510) of gotistobart (also known as BNT316 or ONC-392), in patients with squamous Non-Small Cell Lung Cancer (NSCLC) whose disease progressed on prior immunotherapy and chemotherapy.

Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells (Tregs) within the tumor microenvironment and restore anti-tumor immune activity.

The data showed that treatment with gotistobart led to a statistically significant and clinically meaningful OS benefit, nearly doubling survival compared with Standard-of-Care (SoC) chemotherapy in this patient population. The data were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).

Rama Balaraman, MD, Principal Investigator and medical oncologist, Ocala Oncology Center, Florida, US, said, “Patients with squamous NSCLC continue to face limited treatment options after progression on immunotherapy. Current survival expectations with established therapies remain less than a year, and despite numerous development efforts, chemotherapy has remained the standard of care in this setting for more than a decade. The magnitude of the survival benefit observed with gotistobart as a chemotherapy-free treatment approach in the PRESERVE-003 clinical trial is highly encouraging. If confirmed in the pivotal portion of the phase 3 trial, these findings could transform the Standard of Care in a setting where new therapies are urgently needed.”

At the data cut-off on July 17, 2026, with a median follow-up of 25.4 months, 87 patients with metastatic squamous NSCLC had been randomised to receive either gotistobart monotherapy 6 mg/kg with 2 10 mg/kg loading doses (N=45) or docetaxel 75 mg/m2 (N=42) in the second-line or later treatment setting.

The median OS was 18.5 months for patients treated with gotistobart compared to 10 months for patients treated with docetaxel (HR: 0.56; nominal p-value=0.0295). The safety profile of gotistobart was consistent with previously reported data and remained manageable. Grade ≥3 treatment-related adverse events (AEs) were reported in 20/45 (44.4 percent) patients receiving gotistobart and 20/42 (48.8 percent) patients receiving docetaxel.

Professor Özlem Türeci, MD, Co-Founder and Chief Medical Officer, BioNTech, 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-tumor 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. We look forward to continuing our work with our colleagues at OncoC4 to further explore and realise gotistobart’s full potential.”

The pivotal stage 2 portion of PRESERVE-003 is currently ongoing at over 160 sites globally. Gotistobart previously demonstrated a clinically meaningful OS benefit and durable anti-tumor activity versus docetaxel in stage 1 of the PRESERVE-003 phase 3 trial in patients with squamous NSCLC who had progressed on PD-(L)1 inhibitors.

This data was published in Nature Medicine and presented at the 2026 European Lung Cancer Congress (ELCC) and the IASLC ASCO 2025 North America Conference on Lung Cancer (NACLC).

Pan Zheng, MD, PhD, Co-Founder and Chief Medical Officer, OncoC4, said, “The data support the differentiated mechanism of action of gotistobart as a tumor microenvironment-selective Treg modulator and reinforce our confidence in the therapeutic potential of this distinct CTLA-4-targeting approach to meaningfully shift the treatment landscape in this indication. We are encouraged by the clinical activity and safety profile observed to date and remain focused on advancing gotistobart for patients with this difficult-to-treat disease.”