BioNTech reported promising results from a late-stage clinical trial of its investigational drug gotistobart, which showed a nearly twofold increase in median survival for patients with an aggressive form of lung cancer compared to standard chemotherapy. The study focused on patients with metastatic squamous non-small cell lung cancer whose disease progressed after prior immunotherapy and chemotherapy.

According to BioNTech, patients treated with gotistobart experienced a median overall survival of 18.5 months, whereas those receiving chemotherapy had a median survival of 10 months. These updated findings build on earlier data indicating that gotistobart reduced the risk of death by 54% compared with chemotherapy, although median overall survival had not yet been reached at that time.

Rama Balaraman, a principal investigator in the trial and medical oncologist, noted that current therapies typically yield survival expectations of less than a year. Chemotherapy has remained the standard of care in this setting for over a decade despite numerous attempts to improve outcomes. Balaraman emphasized that, if the survival benefit is corroborated in the next phase of the trial, gotistobart could offer a chemotherapy-free option and potentially transform treatment standards for this patient population.

Gotistobart is designed to enhance the immune system’s ability to combat cancer by targeting and removing cells that allow tumors to evade immune defenses. BioNTech is developing the drug in collaboration with the U.S.-based company OncoC4. The company also reported that the safety profile of gotistobart remained consistent with previous data and was manageable.

These results represent a significant milestone for BioNTech as the company seeks to diversify its oncology portfolio amid declining sales of its COVID-19 vaccine. However, the company recently faced a setback when it discontinued a study of a personalized mRNA vaccine for colorectal cancer, despite earlier enthusiasm driven by successes of similar treatments from competitors such as Moderna Inc. and Merck & Co. in melanoma.

BioNTech aims to bring multiple cancer therapies to market by 2030, with gotistobart being a key component of that strategy. The ongoing trial results will be closely watched by the medical community as they could signal a shift in treatment options for patients with metastatic squamous non-small cell lung cancer.