BioNTech/BMS pumitamig hits 36.7% response in second-line NSCLC
BioNTech and Bristol Myers Squibb have released first data from the global Phase 2 ROSETTA Lung-107 trial evaluating pumitamig, their jointly developed PD-L1xVEGF-A bispecific immunomodulator, in combination with docetaxel for patients with metastatic non-small cell lung cancer whose disease progressed after first-line immunotherapy plus chemotherapy.
Among 30 efficacy-evaluable patients at a 12 July 2026 data cut-off, the combination achieved a confirmed objective response rate of 36.7% and a disease control rate of 90.0%. Median progression-free survival in the full 50-patient treated population was 6.9 months, against a historical benchmark of roughly 3.6 to 3.9 months for docetaxel alone in this setting. The six-month PFS rate stood at 63.3%, and median time to response was 1.4 months.
Trial data and safety
Responses were observed across all PD-L1 expression subgroups, with confirmed ORRs of 42.9% in patients with tumour proportion score below 1%, 33.3% in the TPS 1–49% group, and 40.0% in the TPS 50% or above group. Both squamous (57.1% cORR) and non-squamous (30.4% cORR) histologies responded, a finding the companies say supports pumitamig's potential in an unselected second-line population.
On safety, treatment-related adverse events of any grade were reported in 52.0% of patients, with grade 3 or higher events in 18.0%. Four patients (8.0%) discontinued due to TRAEs. VEGF-related events occurred in 26.0% of patients, though grade 3 events were rare and no grade 4 or 5 VEGF-related events were recorded. There were no pumitamig-related deaths or dose-limiting toxicities, which the companies describe as consistent with the broader pumitamig safety dataset.
Byoung Chul Cho, trial investigator and professor of medical oncology at Yonsei Cancer Center, said the results suggest pumitamig "may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy," a setting where docetaxel has remained the standard of care for years with limited improvement in outcomes.
Market context and competitive landscape
The second-line NSCLC space after immunotherapy-containing regimens represents one of oncology's more challenging commercial and clinical frontiers. Docetaxel's median PFS of under four months in this setting underscores the unmet need, and several companies are pursuing competing approaches, including antibody-drug conjugates and novel checkpoint combinations.
Pumitamig's dual mechanism, simultaneously blocking PD-L1 to restore immune recognition and inhibiting VEGF-A to disrupt tumour vasculature, is shared in concept with other PD-L1xVEGF bispecifics in development, most notably ivonescimab from Akeso/Summit Therapeutics, which has reported competitive Phase 3 data in first-line NSCLC. BioNTech and BMS position their programme as one of the broadest in the class, with seven global Phase 3 trials ongoing across lung, breast, colorectal, and gastric cancer settings, and more than 4,000 patients treated with pumitamig to date.
The ROSETTA Lung-107 dataset is described by the companies as the third global Phase 2 readout for pumitamig in lung cancer. BMS chief medical officer Cristian Massacesi noted that the data "extend our evidence into a second-line setting where current options fall short" and said the companies intend to define a regulatory development path for this indication. No Phase 3 start date or regulatory submission timeline for second-line NSCLC has yet been disclosed. The data were presented as a late-breaking oral presentation at the ESMO Congress 2026 in Madrid.