BioNTech, Bristol Myers present interim data from a Phase 2 pumitamig trial

BioNTech SE (BNTX) and Bristol Myers Squibb (BMY) presented interim data from a global randomized Phase 2 trial evaluating pumitamig, also known as BNT327 or BMS986545, an investigational bispecific antibody targeting PD-L1 x VEGF-A, plus chemotherapy in patients with extensive-stage small cell lung cancer. The data, which are consistent with data presented at the European Lung Cancer Congress 2025 from a Phase 2 trial conducted in China, showed “encouraging anti-tumor responses with a positive trend in the secondary endpoint progression free survival,” the companies stated. Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The data are being presented today as a late-breaker oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona. The interim analysis included 43 patients with untreated extensive-stage small cell lung cancer who received pumitamig in combination with standard of care chemotherapy in two dose levels. At the August 7, 2025 data cut-off, among 38 efficacy-evaluable patients, the confirmed overall response rate was 76.3% and 66.7% at 30 mg/kg and the disease control rate was 100%. The mean best percentage change in tumor size showed a tumor shrinkage of 56.7% with 89.5% of patients achieving early tumor shrinkage. Median progression-free survival was 6.8 months, with mOS not being mature at the time of the analysis. Pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals beyond those typically described for chemotherapy agents and anti-PD-(L)1 and anti-VEGF monotherapies, and a discontinuation rate of 14%. Out of 43 patients, pumitamig-related treatment-emergent adverse events of Grade =3 were reported in 1 patient at dose level 1 and five patients at dose level 2. “These interim data for pumitamig presented today show encouraging signals for our science-driven approach to address two fundamental drivers of small cell lung cancer in one single molecule. Our ultimate goal is to translate science into meaningful survival benefits for many patients by overcoming some of the biggest treatment challenges, not only in small cell lung cancer but also across other difficult-to-treat solid tumors. These interim data for pumitamig represent an important step in the right direction,” said Prof. Ozlem Tureci, M.D., Co-Founder and Chief Medical Officer at BioNTech.