BioNTech SE (BNTX) Form 6-K — Oct 22, 2026
BioNTech announced a clinical trial collaboration and supply agreement with Gilead Sciences to evaluate pumitamig plus 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 (NCT07173751) will evolve to replace chemotherapy with sacituzumab govitecan in its control/comparator design, pending regulatory approval, reflecting the ADC's emergence as the new standard of care. This will be the first global Phase 3 trial of pumitamig combined with an ADC.
Key figures
- Phase3 trials ongoing
- 7
- Patients treated pumitamig
- 4,000+
- Tnbc share of breast cancers
- 10-15%
- Five year survival metastatic tnbc
- 15%
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