BioNTech and BMS report 36.7% response rate for pumitamig in second-line lung cancer at ESMO

BNTX and BMY released early Phase 2 data on October 25 for pumitamig, their PD-L1 x VEGF-A bispecific antibody, in patients with stage IV non-small cell lung cancer (NSCLC) whose disease progressed after first-line immunotherapy plus platinum chemotherapy. The global, open-label, single-arm ROSETTA Lung-107 trial tested pumitamig 1400 mg with docetaxel every three weeks and was presented as a late-breaking abstract at the ESMO Congress in Madrid.

Of 59 patients enrolled, the July 10 data cut included 50 treated patients and 30 who could be evaluated for efficacy. Those 30 showed a confirmed objective response rate of 36.7% and a disease control rate of 90.0%, and median progression-free survival across the 50 treated patients was 6.9 months, with the upper bound of the confidence interval not yet reached. Responses held up across PD-L1 subgroups, and were higher in squamous tumors (57.1%) than non-squamous (30.4%). The companies compared the result with docetaxel alone, which has historically delivered median PFS of about 3.6 to 3.9 months in this setting, but that is a cross-trial benchmark, not a head-to-head comparison.

On safety, grade 3 or higher treatment-related adverse events attributed to pumitamig occurred in 18.0% of patients, 8.0% discontinued for side effects, and there were no pumitamig-related deaths. Immune-related events affected 22.0% of patients, including some grade 4 cases reported in independent coverage.

The context matters for second-line lung cancer, a setting where docetaxel has been hard to beat. PFE saw its own Phase 3 attempt there, the antibody-drug conjugate sigvotatug vedotin, miss its overall survival goal in June, and Endpoints framed this readout against Pfizer looking past that setback. What to watch: the data are small and immature, with only 12.2 weeks of median follow-up, and BioNTech has not announced a randomized Phase 3 in this setting; its four ongoing Phase 3 lung trials cover other settings. BioNTech reports third-quarter results on November 3.