BioNTech SE and Gilead Sciences Inc. announced a clinical trial collaboration and supply agreement to evaluate pumitamig, an investigational bispecific immunomodulator, with Gilead’s TROP2-directed antibody-drug conjugate sacituzumab govitecan (Trodelvy®). The combination will be studied as a first-line treatment for patients with locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer (TNBC).
The collaboration will adapt the ongoing global Phase 3 ROSETTA Breast-01 trial. Pending regulatory approval, the study will replace chemotherapy with sacituzumab govitecan as pumitamig’s combination partner, reflecting the evolving standard of care. It will be the first global Phase 3 trial to evaluate pumitamig with an antibody-drug conjugate.
Under the agreement, BioNTech will continue to sponsor and lead the trial, while Gilead will supply sacituzumab govitecan. BioNTech and Bristol Myers Squibb are co-developing pumitamig. The collaboration aims to improve outcomes for a patient population with high unmet medical need.