BioNTech SE (NASDAQ:BNTX) shares rose 6.4% in pre-market trading on Monday after the company reported updated survival data from stage 1 of the Phase 3 PRESERVE-003 trial evaluating gotistobart in patients with squamous non-small cell lung cancer.
Gotistobart produced median overall survival of 18.5 months, compared with 10.0 months for standard-of-care docetaxel chemotherapy in patients whose disease had progressed following previous immunotherapy and chemotherapy.
The results showed a hazard ratio of 0.56 with a nominal p-value of 0.0295.
PRESERVE-003 Data Include 87 Patients
At the July 17, 2026 data cut-off, the trial had a median follow-up period of 25.4 months. A total of 87 patients with metastatic squamous non-small cell lung cancer had been randomised to receive either gotistobart monotherapy or docetaxel as second-line or later treatment.
The updated findings were presented at the International Association for the Study of Lung Cancer 2026 World Conference on Lung Cancer.
BioNTech is jointly developing gotistobart, also known as BNT316 or ONC-392, with OncoC4, Inc.
BioNTech Reports Safety Findings
Grade 3 or higher treatment-related adverse events were reported in 44.4% of patients treated with gotistobart, compared with 48.8% of patients receiving docetaxel.
BioNTech described the safety profile of gotistobart as manageable.
Gotistobart is an investigational immunotherapy targeting CTLA-4 and is designed to selectively deplete regulatory T cells within the tumour microenvironment.
The drug received Fast Track Designation from the US Food and Drug Administration in 2022 and Orphan Drug Designation for the treatment of squamous non-small cell lung cancer in 2025.
The pivotal stage 2 portion of PRESERVE-003 is continuing at more than 160 sites globally. According to the company, median survival with current standard-of-care treatments for this patient population is less than one year.
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