BioNTech SE delivers landmark survival data in metastatic lung‑cancer trial

BioNTech SE has announced a pivotal advancement in its oncology portfolio, revealing that the selective T‑regulatory cell depleting agent Gotistobart (BNT316/ONC‑392) achieved a 54 % reduction in overall mortality compared with standard chemotherapy in a global Phase 3 study (PRESERVE‑003) for metastatic squamous non‑small‑cell lung cancer (sqNSCLC). The data were presented at the IASLC/ASCO 2025 meeting in North America and corroborated by a separate oral presentation on the same day.

Key clinical findings

  • Overall survival benefit: Median survival in the Gotistobart arm exceeded that of the control by more than 50 %, a result that surpasses the efficacy of many current standard regimens.
  • Safety profile: The safety data were described as “controllable,” with no unexpected adverse events reported across the trial cohort.
  • Dose‑confirmation stage: The study confirmed the optimal dosing schedule, reinforcing the therapeutic index of the compound.

Strategic implications

  • OncoC4 partnership: The collaboration with OncoC4 has accelerated the development of Gotistobart, positioning BioNTech as a leading contender in the T‑regulatory cell targeting space.
  • Pipeline diversification: These results complement the encouraging Phase 2 data for Pumitamig (BNT327/BMS986545), a bispecific PD‑L1 × VEGF‑A antibody, which showed early anti‑tumor activity in triple‑negative breast cancer when combined with chemotherapy.
  • Market outlook: The strong survival signal is expected to reshape investor sentiment, potentially driving the stock toward its 52‑week high of €123.3. The current close price of €84 and a market capitalization of approximately €20.4 billion reflect a valuation that may well be primed for a rebound.

Financial context

  • Price‑to‑earnings ratio: With a negative P/E of –38.1, BioNTech’s valuation remains heavily weighted toward future growth rather than current earnings.
  • Liquidity and market presence: Listed on Xetra, the company trades in euros and maintains a stable presence in the European biotech sector.

The data underscore BioNTech’s capability to translate early‑phase promise into late‑stage clinical success, reinforcing its standing as a key player in the global oncology arena. As the company moves forward with regulatory submissions, stakeholders will be closely monitoring the translation of these survival benefits into real‑world clinical practice and market adoption.