BioNTech says its experimental cancer drug gotistobart has significantly extended survival in patients with a difficult-to-treat form of lung cancer.
The company reported the findings from the PRESERVE-003 Phase 3 trial on Monday. The study examined patients with metastatic squamous non-small cell lung cancer, or NSCLC, whose disease progressed after earlier immunotherapy and chemotherapy.
According to BioNTech, gotistobart nearly doubled median overall survival compared with standard chemotherapy. Patients receiving the drug had a median overall survival of 18.5 months, compared with 10 months for those receiving docetaxel.
The results were presented at the 2026 World Conference on Lung Cancer.
Gotistobart Shows Strong Survival Results
Researchers analyzed data from 87 patients in the first stage of the Phase 3 study.
Among them, 45 received gotistobart. Another 42 received docetaxel, a chemotherapy drug that doctors commonly use in this treatment setting.
The data showed a hazard ratio of 0.56 for overall survival. BioNTech reported a nominal p-value of 0.0295.
In simple terms, the results suggest that patients who received gotistobart faced a lower risk of death than those who received docetaxel.
However, the results come from the first stage of a larger two-stage trial. The pivotal second stage remains underway. The global study is designed to test gotistobart against docetaxel in metastatic squamous NSCLC.
Patients Have Limited Treatment Options
Squamous NSCLC can become especially difficult to treat after the disease progresses following immunotherapy and chemotherapy.
Doctors have used chemotherapy such as docetaxel in this setting for years. BioNTech and its researchers say patients still need more treatment options.
Dr. Rama Balaraman, the trial’s principal investigator, called the survival difference encouraging. He said the results could change treatment if the larger portion of the study confirms the findings.
That confirmation remains important because the current results do not yet establish gotistobart as an approved treatment.
Safety Results Remain Manageable
The company also reported safety data from the trial.
Severe treatment-related side effects occurred in 44.4% of patients who received gotistobart. The same measure reached 48.8% among patients who received docetaxel.
BioNTech said the drug’s safety profile remained consistent with earlier findings.
The company is developing gotistobart with OncoC4. The treatment is also known as BNT316 or ONC-392. It targets CTLA-4 and aims to reduce regulatory T cells inside tumors.
The goal is to help the immune system mount a stronger response against cancer cells.
Larger Phase 3 Study Continues
The PRESERVE-003 trial includes two stages and is testing gotistobart in patients with metastatic squamous NSCLC who progressed after previous PD-(L)1 inhibitor treatment.
The trial has enrolled patients at sites around the world. Researchers will continue to compare the investigational drug with docetaxel while monitoring survival and side effects.
BioNTech previously reported a survival benefit from the first stage of the trial. The company said updated results continue to support the potential of gotistobart as a chemotherapy-free treatment approach.
Still, gotistobart has not yet become a standard or approved lung cancer treatment.
The ongoing pivotal stage will determine whether the promising early results hold up in a larger patient population. If they do, the findings could strengthen the case for a new treatment option for patients with advanced squamous NSCLC who have limited choices after earlier therapies.
