BioNTech and Bristol Myers Squibb (BMS) have reported encouraging Phase 2 results for their experimental cancer drug pumitamig in patients with advanced non-small cell lung cancer (NSCLC), a group with limited treatment options after their disease progresses on immunotherapy and chemotherapy.

 

The combination of pumitamig and chemotherapy drug docetaxel achieved a confirmed objective response rate of 36.7% among 30 patients evaluated for efficacy, while the disease control rate reached 90%, according to data announced recently.

 

The global Phase 2 ROSETTA Lung-107 trial also reported a median progression-free survival (PFS) of 6.9 months among all 50 treated patients. PFS measures the time patients live without their disease worsening.

 

The results are particularly significant because patients whose advanced NSCLC progresses after first-line immunotherapy plus chemotherapy face a substantial unmet medical need. Docetaxel remains a standard treatment in this setting, with historical median PFS of approximately 3.6 months for non-squamous disease and 3.9 months for squamous disease.

 

However, the latest findings are early-stage clinical results and do not establish that pumitamig is superior to docetaxel alone. The trial was an open-label, single-arm Phase 2 study without a control group.

 

“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, Yonsei University College of Medicine, Seoul, Republic of Korea.

 

“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. These findings support continued investigation of pumitamig in this population with high unmet need.”

 

The study evaluated pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator, in combination with docetaxel in patients with metastatic NSCLC whose disease progressed on or after first-line immunotherapy plus chemotherapy.

 

Among the 30 patients assessed for efficacy, the combination produced a confirmed objective response rate of 36.7% and a disease control rate of 90%.

 

BioNTech and BMS said the results extend the clinical evidence for pumitamig into a treatment setting where options remain limited.

 

“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” said Prof. Özlem Türeci, 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. 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.”

 

BMS said the latest results represent the third global Phase 2 dataset showing activity for pumitamig in lung cancer across PD-L1 expression levels.

 

“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,” said 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.”