Clinical TrialJun 1, 2026, 08:03 AM
BioNTech & BMS Pumitamig Phase 2 Data Shows Encouraging Efficacy in NSCLC
AI Summary
BioNTech SE and Bristol Myers Squibb Company announced encouraging interim Phase 2 data from the ROSETTA Lung-02 clinical trial for pumitamig (BNT327/BMS-986545) in previously untreated advanced non-small cell lung cancer (NSCLC). The investigational bispecific immunomodulator, combined with chemotherapy, demonstrated robust anti-tumor activity with high objective response rates across NSCLC subtypes and PD-L1 expression levels. The companies are advancing pumitamig into a comprehensive global Phase 3 development program.
Key Highlights
- Pumitamig plus chemotherapy showed 63.6% cORR in non-squamous NSCLC at lower dose.
- Pumitamig plus chemotherapy showed 72.7% cORR in squamous NSCLC at lower dose.
- Overall cORR was 57.1% in non-squamous and 68.4% in squamous NSCLC.
- Disease control rate (DCR) was 100% in response-evaluable patients.
- Grade ">=" 3 treatment-related adverse events occurred in 48.8% of patients.
- Treatment discontinuation due to pumitamig-related TRAEs was 9.3% (4 patients).
- Pumitamig is advancing to Phase 3 trials, including ROSETTA Lung-02, Lung-201, and Lung-202.
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