Clinical TrialMay 30, 2026, 02:16 PM
BioNTech's Pumitamig Shows Encouraging Phase 2 NSCLC Efficacy
AI Summary
BioNTech and Bristol Myers Squibb announced encouraging interim Phase 2 data for pumitamig (PD-L1xVEGF-A bispecific immunomodulator) plus chemotherapy in first-line non-small cell lung cancer (NSCLC). The data showed robust anti-tumor activity with high objective response rates across PD-L1 expression levels and subtypes, including 63.6% in non-squamous and 72.7% in squamous NSCLC at the lower dose. Pumitamig demonstrated a manageable safety profile and is advancing through a comprehensive global Phase 3 development program, including the actively enrolling pivotal Phase 3 part of the ROSETTA Lung-02 trial and two additional global Phase 3 trials.
Key Highlights
- Interim Phase 2 data from ROSETTA Lung-02 trial for pumitamig in first-line NSCLC presented at ASCO 2026.
- Confirmed objective response rate (cORR) of 57.1% in non-squamous and 68.4% in squamous NSCLC.
- Higher cORR at lower dose: 63.6% for non-squamous and 72.7% for squamous NSCLC.
- cORR across PD-L1 levels: 47.6% (TPS < 1%), 77.8% (TPS 1-49%), 100% (TPS ">= 50%).
- Disease control rate (DCR) of 100% observed in response-evaluable patients.
- Grade ">= 3 treatment-related adverse events in 48.8% of patients; 23.3% considered pumitamig-related.
- Pumitamig is advancing into Phase 3, with 7 global Phase 3 trials ongoing across various cancers.
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