Pumitamig trial data released on October 25, 2026, showed a 36.7% confirmed response rate among 30 evaluable patients with advanced non-small cell lung cancer treated with the experimental drug and docetaxel. BioNTech and Bristol Myers Squibb said the patients’ disease had progressed during or after initial immunotherapy and chemotherapy.

Key Takeaways

  • Median progression-free survival was 6.9 months among 50 treated patients, with a median follow-up of 12.2 weeks.
  • The single-arm study had no direct comparison group, so the results do not establish whether the combination is better than docetaxel alone.
  • Severe pumitamig-related adverse events occurred in 18.0% of the 50 patients evaluated for safety.

Pumitamig trial results and patient group

The global Phase 2 ROSETTA Lung-107 study is testing pumitamig with docetaxel in patients with metastatic squamous or non-squamous non-small cell lung cancer. The companies presented the first data at the European Society for Medical Oncology Congress in Madrid.

At the July 10, 2026 data cutoff, the analysis included 50 patients, of whom 33 remained on treatment. Among the 30 evaluable for efficacy, the disease control rate was 90.0%, and the median time to response was 1.4 months.

Responses were observed in both cancer subtypes and across levels of PD-L1 expression, a marker used in assessing some immunotherapies. Median progression-free survival measures the time until disease worsens or a patient dies.

Safety findings and study limitations

Pumitamig-related adverse events of any grade occurred in 52.0% of the 50 patients evaluated for safety, while grade 3 or higher events occurred in 18.0%. Adverse events led to treatment discontinuation in four patients. The companies reported no pumitamig-related deaths or new safety signals.

The study is open-label and single-arm, meaning patients received the combination without a randomly assigned comparison treatment. The findings are early, and the effect of pumitamig cannot be separated from that of docetaxel in this study.

Broader development program

Pumitamig is an investigational drug jointly developed by BioNTech and Bristol Myers Squibb to bind to PD-L1 and VEGF-A. The companies said the ROSETTA Lung-107 data will inform further development in patients whose disease has progressed after initial treatment.

Seven global Phase 3 trials of pumitamig with chemotherapy are ongoing across lung, breast, colorectal and gastric cancers, including four lung cancer trials in other treatment settings.

Read More News

More FinanceVelix news

Disclaimer

This FinanceVelix article provides general information, not personalized financial, investment, legal, or tax advice. Market prices, interest rates and economic conditions can change; investments carry a risk of loss. Facts reflect the material available when published and may change. Check important information independently and consult a qualified professional when needed. Mentioning an asset, company, or service is not an endorsement.