BioNTech Advances Phase 3 Clinical Trial of Pumitamig in Combination with Gilead’s TROP2-Directed ADC Sacituzumab Govitecan in Triple-Negative Breast Cancer
BioNTech announced a clinical trial collaboration and supply agreement with Gilead Sciences to evaluate pumitamig in combination with the TROP2-directed ADC sacituzumab govitecan (Trodelvy) as first-line treatment for PD-L1 low or negative metastatic triple-negative breast cancer. The global Phase 3 ROSETTA Breast-01 trial will be adapted, pending regulatory approval, to replace chemotherapy with sacituzumab govitecan, reflecting the evolving standard of care; BioNTech remains trial sponsor and Gilead will supply the ADC.
Key figures
- Drug Name
- pumitamig (BNT327/BMS986545)
- Phase Of Trial
- Phase 3
- Trial
- ROSETTA Breast-01 (NCT07173751)
- Indication
- first-line locally advanced or metastatic PD-L1 low/negative triple-negative breast cancer
- Combination drug
- sacituzumab govitecan (Trodelvy)
- Phase2 trials ongoing
- 10+
- Phase3 trials ongoing
- 7
- Patients treated to date
- More than 4,000
AI analysis
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