BioNTech’s Pumitamig Achieves Up to 72.7% Response in Phase 2 NSCLC Trial
BNTX•Interim Phase 2 data from the global ROSETTA Lung-02 trial show pumitamig plus chemotherapy achieved cORRs of 57.1% in non-squamous and 68.4% in squamous NSCLC, rising to 63.6% and 72.7% at the lower dose. Responses reached 100% in PD-L1 TPS ≥50% patients with manageable grade ≥3 TRAEs in 48.8%.
1. Interim Efficacy Data
Interim Phase 2 results from the global ROSETTA Lung-02 trial in 40 first-line NSCLC patients showed pumitamig plus chemotherapy achieved cORRs of 57.1% in non-squamous and 68.4% in squamous subtypes, rising to 63.6% and 72.7% at the lower dose; responses were high across PD-L1 levels, reaching 100% in TPS ≥50%.
2. Safety Profile and Development Plans
The safety profile was manageable, with grade ≥3 treatment-related adverse events in 48.8% of patients and a 9.3% discontinuation rate. BioNTech and Bristol Myers Squibb are advancing pumitamig into the pivotal Phase 3 part of ROSETTA Lung-02 versus pembrolizumab plus chemotherapy and two additional Phase 3 trials in stage III and high PD-L1 NSCLC.
