BioNTech partners with Gilead on Phase 3 breast cancer combination trial
BNTX•BioNTech and Gilead entered a clinical trial collaboration and supply agreement to evaluate pumitamig with sacituzumab govitecan in a Phase 3 trial for certain patients with advanced triple-negative breast cancer.
1. Phase 3 trial collaboration
BioNTech and Gilead will evaluate pumitamig combined with sacituzumab govitecan in the Phase 3 ROSETTA Breast-01 trial. The study targets first-line treatment of locally advanced or metastatic triple-negative breast cancer with low or negative PD-L1 expression.
2. Roles and treatment plan
Gilead will supply sacituzumab govitecan, while BioNTech will remain the trial sponsor and lead the study. Subject to regulatory approval, sacituzumab govitecan will replace chemotherapy as both the combination partner and comparator treatment. Pumitamig, jointly developed with Bristol Myers Squibb, will be evaluated in combination with an antibody-drug conjugate in a global Phase 3 trial for the first time.
