Pumitamig (PD-L1×VEGF-A bispecific) + chemo drives 70% ORR in 1L NSCLC (PD-L1–agnostic)

Pumitamig (BNT327/BMS-986545) is an investigational PD-L1×VEGF-A bispecific antibody intended to combine checkpoint blockade with tumor-localized VEGF-A neutralization, and it was tested with Q3W carboplatin-based chemotherapy in the Phase 2 dose-optimization portion of the global ROSETTA Lung-02 Phase 2/3 trial (NCT06712316) in treatment-naïve advanced NSCLC without actionable alterations (NSQ carbo+pemetrexed; SQ carbo+paclitaxel). At the Nov 21, 2025 cutoff, 44 patients were enrolled and 40 were response-evaluable: ORR was 70.0% (28/40; CR 5% [2/40], PR 65% [26/40]), confirmed ORR was 52.5% (21/40; 5 pending confirmation), and DCR was 100% (DOR not mature); activity was reported across PD-L1 strata (central testing available in n=35). Safety (N=43) showed TRAEs in 93.0%, grade ≥3 TRAEs in 44.2% (pumitamig-related grade ≥3: 18.6%), pumitamig-related discontinuations in 4.7%, irAEs in 14.0% (grade ≥3: 2.3%), and bleeding in 16.3% (grade 3: 2.3%); for calibration, pembrolizumab + platinum/pemetrexed in KEYNOTE-189 reported ORR ~48% in 1L metastatic nonsquamous NSCLC, and pembrolizumab + carbo/(taxane) in KEYNOTE-407 is the established backbone in squamous disease.