BioNTech’s Oncology Candidate Shows Transformative Survival Benefit in Late-Stage Trial

BioNTech US09075V1026

New clinical data released by BioNTech SE over the weekend points to a potential paradigm shift for the company's valuation. The German biotech firm announced that its investigational antibody, gotistobart, demonstrated a substantial survival advantage in a Phase 3 trial for metastatic lung cancer. This development, coupled with the nearing completion of its CureVac acquisition, is reshaping the investment narrative around the company.

Detailed results from the PRESERVE-003 trial, presented at the IASLC ASCO 2025 conference in Chicago, revealed compelling efficacy. After twelve months, 63.1% of patients with metastatic squamous non-small cell lung cancer (NSCLC) treated with gotistobart were still alive. This figure starkly contrasts with the 30.3% survival rate observed in the control group receiving the standard chemotherapy, docetaxel.

The reported hazard ratio of 0.46 corresponds to a 54% reduction in the risk of death. At the time of the data analysis, the median overall survival for patients on the gotistobart regimen had not yet been reached. In the comparator arm, median survival stood at ten months. The magnitude of this clinical benefit has surpassed previous analyst expectations for the drug candidate, which is being co-developed with OncoC4.

Strategic Expansion Through CureVac Acquisition Progresses

In a parallel strategic move, BioNTech confirmed the successful advance of its takeover of CureVac. By December 3, tendered shares representing 81.74% of CureVac's outstanding stock had been offered, a level comfortably above the minimum acceptance threshold. A subsequent acceptance period remains open until December 18.

This acquisition is set to bolster BioNTech's strategic position by integrating key mRNA technology platforms, patents, and manufacturing capabilities from its Tübingen-based competitor.

A New Foundation for Valuation Emerges

The confluence of a major clinical breakthrough and strategic expansion is altering the fundamental discussion surrounding BioNTech's equity. While the company reported a net loss for the third quarter of 2025, management subsequently raised its full-year revenue guidance to a ceiling of €2.8 billion.

The clear superiority of gotistobart over established chemotherapy provides, for the first time, a concrete basis for valuing BioNTech's pipeline that is independent of its COVID-19 vaccine revenue. The market will gain further clarity when the company releases its complete annual figures on January 15, 2026. These results will indicate whether BioNTech can successfully convert its pipeline successes into sustainable market share.