BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy
Key Highlights
- ➤Pumitamig plus docetaxel delivered 36.7% confirmed objective response rate
- ➤Median progression-free survival reached 6.9 months in treated patients
- ➤Responses spanned squamous and non-squamous NSCLC and all PD-L1 levels
- ➤Four global Phase 3 trials are ongoing for pumitamig
- ➤Grade ≥3 treatment-related adverse events occurred in 18.0% of patients
Expert Statements
Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine
“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.”
Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine
“These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy.”
Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine
“These findings support continued investigation of pumitamig in this population with high unmet need.”
Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech
“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy.”
Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech
“These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited.”
Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech
“Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”
Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb
“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short.”
Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb
“Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”
* Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapy * An early median progression-free survival of 6.9 months was observed * Significant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel * Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care MAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial (NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy.
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