WASHINGTON: An experimental antibody drug called gotistobart has shown promising results in a clinical trial for patients with advanced squamous non-small cell lung cancer, with patients receiving the treatment recording longer overall survival than those given standard chemotherapy.
According to BioNTech, preliminary results from the Phase 3 PRESERVE 003 trial showed a median overall survival of 18.5 months among patients treated with gotistobart, compared with 10 months for those receiving the chemotherapy drug docetaxel.
The trial involved 87 patients whose lung cancer had progressed despite earlier treatment with immunotherapy and chemotherapy. The patients received gotistobart or docetaxel as a second-line or later treatment.
Survival Benefit Reported
The company said the difference represented an 8.5-month improvement in median overall survival for patients receiving gotistobart. As of the July 17, 2026 data review, the median follow-up period was 25.4 months.
The findings showed a statistically significant and clinically meaningful improvement in overall survival, according to BioNTech.
Dr. Rama Balaraman, a medical oncologist at Ocala Oncology Center in Florida and principal investigator of the trial, said treatment options remain limited for patients with squamous non-small cell lung cancer whose disease progresses after immunotherapy.
He said that if the results are confirmed in the pivotal Phase 3 trial, the treatment could potentially lead to a significant change in the current standard of care.
Focus on Immune Response
BioNTech co-founder and Chief Medical Officer Professor Özlem Türeci said the importance of new treatments in later lines of cancer therapy lies partly in their potential to reactivate suppressed immune responses and strengthen the body’s ability to attack cancer cells.
Gotistobart is an investigational antibody treatment being studied in patients whose disease has continued to progress despite previous therapies.
Safety Data Also Reported
The trial also produced safety data. BioNTech reported that treatment-related Grade 3 or higher adverse events occurred in 20 of 45 patients receiving gotistobart, representing 44.4%.
The pivotal portion of the PRESERVE 003 Phase 3 trial is currently being conducted at more than 160 centers worldwide.
The company said earlier-stage testing had also produced encouraging results for gotistobart, including signals of longer overall survival and durable anti-tumor activity compared with docetaxel in patients whose disease had progressed following previous treatment.
Gotistobart remains an investigational medicine. Its potential clinical benefits, safety profile and future use will depend on the full results of the ongoing Phase 3 trial and subsequent regulatory and medical reviews.