BioNTech Shares Climb on Positive Phase 3 Lung Cancer Trial Data

BioNTech SE (NASDAQ: BNTX) shares climbed 6.4% in premarket trading on Monday following the release of promising data from a Phase 3 trial of its experimental cancer therapy. The drug, gotistobart, demonstrated a significant improvement in survival rates for patients with a specific type of advanced lung cancer.

Key Trial Results

Updated data from stage 1 of the PRESERVE-003 Phase 3 clinical trial showed that gotistobart nearly doubled patient survival times. The findings were presented at the International Association for the Study of Lung Cancer 2026 World Conference on Lung Cancer.

The trial enrolled patients with metastatic squamous non-small cell lung cancer (NSCLC) whose disease had progressed following prior immunotherapy and chemotherapy. Key results from the 87-patient cohort include:

• Median Overall Survival: 18.5 months for patients treated with gotistobart, compared to 10.0 months for those receiving standard-of-care chemotherapy (docetaxel).
• Reduced Risk: The results showed a hazard ratio of 0.56, indicating a 44% reduction in the risk of death for the gotistobart group compared to the control arm.
• Safety Profile: The drug's safety profile was deemed manageable, with rates of severe treatment-related adverse events comparable to standard chemotherapy (44.4% for gotistobart vs. 48.8% for docetaxel).

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Market and Development Context

The positive data is significant as the median survival for this heavily pre-treated patient population is typically less than one year with current treatments. Gotistobart, also known as BNT316 or ONC-392, is an investigational CTLA-4-targeting immunotherapy designed to selectively target and deplete regulatory T cells that can suppress an anti-tumor immune response.

BioNTech is developing the drug jointly with OncoC4, Inc. The U.S. Food and Drug Administration has already granted the therapy Fast Track Designation in 2022 and Orphan Drug Designation in 2025, underscoring the unmet medical need for this condition. The pivotal stage 2 portion of the PRESERVE-003 study is now ongoing at more than 160 sites globally.