BioNTech and BMS Announce First Global Data for PD-L1xVEGF Bispecific in Small Cell Lung Cancer, Set Phase 3 Dose
BioNTech and Bristol Myers Squibb (BMS) presented the first global data for their PD-L1xVEGF bispecific antibody (BNT327, also called pumitamig) in small cell lung cancer at the 2025 World Conference on Lung Cancer1.
In the global phase 2 trial, pumitamig combined with chemotherapy achieved a confirmed overall response rate (ORR) of 76.3% among 38 evaluable untreated extensive-stage small cell lung cancer (ES-SCLC) patients13.
All patients in the study achieved disease control, with a median duration of response of five months, and response rates were 85% at 20 mg/kg and 66.7% at 30 mg/kg1.
The global phase 3 dose has been selected and is being used in an ongoing phase 3 trial of pumitamig plus chemotherapy for extensive-stage SCLC. Data readout from the phase 3 trial is expected by 20283.
BNT327 targets two key pathways:
PD-L1 (to restore T-cell mediated anti-tumor immunity) and VEGF-A (to inhibit tumor growth and angiogenesis), aiming for a synergistic effect45.
Recent Chinese phase 2 data with BNT327 showed a median overall survival of 16.8 months and 72.7% 1-year survival rate, which is promising compared to existing treatments from Roche and AstraZeneca2.
BMS and BioNTech entered into a major global co-development agreement valued up to $11 billion to accelerate development of BNT327 across multiple tumor types, including ES-SCLC, non-small cell lung cancer (NSCLC), and triple negative breast cancer (TNBC)45.
Sources:
1. https://www.fiercebiotech.com/biotech/biontech-bms-tout-first-global-data-pd-l1xvegf-bispecific-set-phase-3-dose-small-cell-lung
2. https://www.fiercebiotech.com/biotech/biontech-shows-lung-cancer-survival-data-behind-phase-3-push-red-hot-bispecific
3. https://www.biopharmadive.com/news/biontech-bristol-myerspumitamig-lung-cancer-phase-2-results/759523/
4. https://www.nasdaq.com/articles/biontech-and-bristol-myers-squibb-announce-global-co-development-bnt327-novel-bispecific