ROSETTA Lung-02 showed encouraging first-line activity for pumitamig (BNT327/BMS986545) combined with chemotherapy in non–small cell lung cancer, presented at the 2026 ASCO Annual Meeting. In the phase 2 dataset (n=40), the unconfirmed overall response rate was 72.5%, with a confirmed ORR of 62.5% and a confirmed disease control rate of 100%. Safety signals were limited: the regimen reported an acceptable toxicity profile across both histologies, with no new safety issues. The trial recorded two grade 3 VEGF-related events (including a bleeding event that resolved) and two grade 3 immune-related adverse effects in combination. The results span by PD-L1 expression and histology, setting up the next question for the program—whether the response depth and safety translate into a registrational path.
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