Overview

• BioNTech and Bristol Myers reported interim results in 38 evaluable untreated extensive-stage small cell lung cancer patients receiving pumitamig plus chemotherapy.
• The regimen delivered a 76.3% confirmed overall response with 100% disease control and an average tumor shrinkage of 56.7%.
• Median progression-free survival was 6.8 months, with overall survival not yet mature at the Aug. 7 data cutoff.
• At 20 mg/kg the response rate was 85% versus 66.7% at 30 mg/kg, and Grade ≥3 pumitamig-related adverse events were seen in one and five patients, respectively.
• A head-to-head Phase 3 trial (ROSETTA-LUNG-01) is comparing the regimen with atezolizumab plus chemotherapy, with a potential readout that may not arrive until 2028, and BNTX shares fell about 8% while BMY slipped about 2% Monday.