By Fineline Cube 
BioNTech SE (NASDAQ: BNTX) and Bristol-Myers Squibb (BMS, NYSE: BMY) disclosed interim data from a global, randomized Phase 2 study (NCT06449209) evaluating the bispecific antibody pumitamig (BNT327/BMS986545) in combination with chemotherapy for patients with extensive‑stage small‑cell lung cancer (ES‑SCLC).
Key Efficacy Findings
| Metric | Overall | Dose Level 1 (20 mg/kg) | Dose Level 2 (30 mg/kg) |
|---|---|---|---|
| Overall Response Rate (ORR) | 76.3 % | 85.0 % | 66.7 % |
| Disease Control Rate (DCR) | 100 % | – | – |
| Median PFS (mPFS) | 6.8 mo | 6.3 mo | 7.0 mo |
| Median OS | Not mature | – | – |
- Efficacy‑evaluable cohort: 38 patients.
- Safety: No new signals; manageable toxicity profile.
Pumitamig: A Novel Dual‑Target Approach
- Mechanism: Bispecific antibody that binds PD‑L1 on tumor cells while delivering VEGF‑A blockade directly to the tumor micro‑environment.
- Rationale: Localized anti‑angiogenic activity aims to increase therapeutic precision and reduce systemic exposure compared with conventional anti‑VEGF agents.
- Development: Co‑developed by BioNTech and BMS, building on their respective strengths in immuno‑oncology and targeted therapeutics.
Strategic Implications
- Clinical Momentum – The 76 % ORR and 100 % DCR in a heavily pretreated ES‑SCLC population underscore pumitamig’s potential to redefine first‑line therapy.
- Pipeline Synergy – Results reinforce BioNTech’s expanding bispecific platform and BMS’s commitment to immuno‑targeted oncology.
- Future Directions – Mature overall‑survival data and larger cohort enrollment are expected to validate the durability of the observed benefit.-Fineline Info & Tech