Pumitamig results lift hopes in hard-to-treat lung cancer

Pumitamig results presented at the European Society for Medical Oncology Congress in Madrid on Sunday showed a confirmed objective response rate of 36.7% among patients with metastatic non-small cell lung cancer whose disease had progressed after immunotherapy plus chemotherapy, according to BioNTech and Bristol Myers Squibb.

The data came from a global trial that tested pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator, combined with docetaxel. Patients in the trial had stage IV squamous or non-squamous disease and had already received immunotherapy plus chemotherapy as their initial treatment. The companies announced the findings in a statement and said the presentation was a late-breaking rapid oral session at the congress.

"Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years," said Byoung Chul Cho, trial investigator and professor of medical oncology at Yonsei Cancer Center in Seoul. Cho added that the findings support continued investigation of pumitamig in this population with high unmet need.

What the trial showed

At the data cutoff in July, the analysis covered 30 efficacy-evaluable patients. The disease control rate was 90.0%, and the median time to response was 1.4 months. Median follow-up was 12.2 weeks, and responses were seen in both squamous and non-squamous disease and across PD-L1 expression levels.

Response rates were 42.9% in tumours with the lowest PD-L1 expression, 33.3% in the middle group, and 40.0% in the highest group. In the overall treated population, median progression-free survival was 6.9 months, with a six-month progression-free survival rate of 63.3%. For comparison, the companies cited historical median progression-free survival of about 3.6 months for non-squamous disease and 3.9 months for squamous disease with docetaxel alone after prior immunotherapy plus chemotherapy.

Docetaxel has been the standard option for years in this setting, yet outcomes after progression on immunotherapy plus chemotherapy have remained poor. Non-small cell lung cancer accounts for about 85% of lung cancer cases and remains the leading cause of cancer-related deaths worldwide, according to the companies. A treatment that produces responses across PD-L1 levels could therefore matter for patients who have few options left, although the trial was small and the follow-up short.

Pumitamig is designed to bind to PD-L1 and VEGF-A, aiming to restore the immune system's ability to recognise tumour cells while cutting off the blood supply that feeds tumours. The companies are studying the drug in lung cancer and other tumour types, including breast, colorectal, and gastric cancers, in ongoing Phase 3 trials.

Safety and what comes next

The safety analysis covered the treated population. Treatment-related adverse events of any grade were reported in 52.0% of patients, and severe treatment-related events occurred in 18.0%. Treatment was discontinued because of treatment-related events in 8.0% of patients. Immune-related events occurred in 22.0% of patients, VEGF-related events in 26.0%, and bleeding events in 16.0%, limited to lower grades. There were no pumitamig-related deaths or dose-limiting toxicities, and the companies described the safety profile as manageable, consistent with earlier datasets for the drug.

In the dose-expansion part of the trial, patients received pumitamig at a dose of 1400 mg plus docetaxel at 75 mg per square metre every three weeks. The trial enrolled patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States, and patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded.

BioNTech chief medical officer Özlem Türeci said the combination extends the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Bristol Myers Squibb chief medical officer Cristian Massacesi said the data extend the evidence into a later treatment setting where current options fall short, and that the companies are continuing to build evidence for pumitamig across lung cancer types and treatment lines.

The presentation took place on October 25, 2026, during a congress in Madrid that runs until October 27. The companies said the findings will inform further development of pumitamig in this underserved population. The drug remains investigational, which means it has not been approved for this use, and larger trials will be needed to confirm whether the early response and survival signals hold up over longer follow-up. Related GenZ NewZ coverage includes a report on two studies linking antioxidant-rich diets with lower lung cancer risk and a report on how protein maps could change how new drugs are found. Details of the announcement were reported by Quiver Quantitative, and OncoDaily has published a trial summary.