BioNTech and Bristol Myers Squibb reported first data on October 25 from the global Phase 2 ROSETTA Lung-107 trial of pumitamig, their PD-L1 by VEGF-A bispecific antibody, combined with docetaxel in metastatic non-small cell lung cancer that had progressed on or after first-line immunotherapy plus chemotherapy. The confirmed objective response rate was 36.7 percent, disease control was 90.0 percent among response-evaluable patients, and early median progression-free survival was 6.9 months. Responses appeared in both squamous and non-squamous disease and across PD-L1 expression levels, including PD-L1-negative tumours.
The companies set the result against the setting’s history: docetaxel alone, the longstanding standard after chemoimmunotherapy fails, has average progression-free survival below four months. On safety, 18 percent of patients had grade 3 or higher pumitamig-related treatment-related adverse events in the OncoDaily summary of the presentation, with no dose-limiting toxicities and no treatment-related deaths. This is the third global Phase 2 dataset for pumitamig in lung cancer, the companies said.
The discipline matters more than the headline. ROSETTA Lung-107 is a small, single-arm Phase 2 with short follow-up, 50 treated patients and 30 response-evaluable, so the 6.9 month figure is a comparison against history, not against a randomised docetaxel arm. The investigator quoted in the release, Byoung Chul Cho of Yonsei Cancer Center in Seoul, framed it the same way: findings that support continued investigation in a population with high unmet need.
For Bristol Myers, pumitamig is a partnered bet on the bispecific class that Chinese developers first validated, and this is its first global dataset in the post-immunotherapy setting. Randomised Phase 3 data, not this signal, will decide whether the class displaces docetaxel or joins it.