BioNTech SE (Nasdaq: BNTX) and OncoC4, Inc. presented updated clinical trial data showing that their investigational drug gotistobart nearly doubled median overall survival compared with standard-of-care chemotherapy in previously treated patients with squamous non-small cell lung cancer (NSCLC).

The data, from stage 1 of the PRESERVE-003 Phase 3 clinical trial, showed a median overall survival of 18.5 months for patients treated with gotistobart versus 10.0 months for patients treated with docetaxel, a standard chemotherapy. The hazard ratio was 0.56, with a nominal p-value of 0.0295. The findings were presented at the International Association for the Study of Lung Cancer 2026 World Conference on Lung Cancer.

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 randomized. Forty-five patients received gotistobart monotherapy and 42 received docetaxel. Grade 3 or higher treatment-related adverse events were reported in 44.4% of patients receiving gotistobart and 48.8% of patients receiving docetaxel.

Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to selectively deplete regulatory T cells within the tumor microenvironment. It has received Fast Track Designation from the U.S. Food and Drug Administration for metastatic NSCLC, Orphan Drug Designation for squamous NSCLC, and Breakthrough Therapy Designation from China's National Medical Products Administration.

The pivotal stage 2 portion of the PRESERVE-003 trial is ongoing at more than 160 sites globally. Stage 1 data from the trial were previously published in Nature Medicine.

According to the press release, squamous NSCLC carries a five-year relative survival rate of 15% and a median overall survival of 11 months in the United States. Gotistobart remains investigational and has not been approved by any regulatory authority.