BioNTech, Gilead Expand Phase 3 Breast Cancer Trial to Test Pumitamig With Trodelvy

BioNTech SE (BNTX) has entered a clinical trial collaboration with Gilead Sciences (GILD) to test pumitamig combined with Trodelvy (sacituzumab govitecan) as a first-line treatment for advanced triple-negative breast cancer with low or negative PD-L1 expression. The agreement modifies the ongoing global Phase 3 ROSETTA Breast-01 trial. Under the revised design, pending regulatory approval, Trodelvy—a TROP2-directed antibody-drug conjugate—will replace chemotherapy in the study's comparator arm. BioNTech will continue to sponsor and lead the trial, while Gilead will supply Trodelvy. Pumitamig, jointly developed by BioNTech and Bristol Myers Squibb, targets PD-L1 and VEGF-A. BioNTech said ROSETTA Breast-01 will be the first global Phase 3 trial evaluating pumitamig with an antibody-drug conjugate, following positive Phase 2 data. The combination remains investigational; safety and efficacy have not been established. BNTX closed Wednesday's trading at $91.29, up 0.13%, and was at $90.50 in pre-market trading, down 0.87%.