BioNTech, BMS aim to upend lung cancer treatment with new bispecific drug

BioNTech and Bristol Myers Squibb (BMS) unveiled promising global phase 2 data for pumitamig (BNT327), a PD-L1xVEGF bispecific antibody, in extensive-stage small cell lung cancer (ES-SCLC), showing a 76.3% overall response rate (ORR) when combined with chemotherapy.

Why it matters: These results rival, and in some metrics outperform, the current standard-of-care regimen (Tecentriq plus chemo), supporting the potential of pumitamig as a next-gen immuno-oncology backbone and possibly redefining first-line treatment for ES-SCLC.

Backstory: In 2024, BioNTech acquired full rights to pumitamig through an $800M+ deal with China-based Biotheus. BMS joined as a co-development partner in 2025 under an $11.1B collaboration. Previous data from a China-only phase 2 trial showed even stronger results (85% ORR, 6.9 months progression-free survival ).

Big picture: BioNTech and BMS are positioning pumitamig not only to replace PD-(L)1 inhibitors like Tecentriq, but also as a foundational drug for future ADC-based regimens; potentially reducing reliance on traditional chemo across multiple cancers.

What’s next: Pumitamig is already in a phase 3 trial (Rosetta Lung-01) for first-line ES-SCLC, comparing it to Tecentriq plus chemo. Other trials include Rosetta Lung-02 (NSCLC with TROP2 ADC), Rosetta Breast-01 (triple-negative breast cancer, starting in 2025), and several phase 1/2 studies pairing pumitamig with ADCs like B7-H3, HER2, and HER3 to explore chemo-free options.