BioNTech advances phase 3 clinical trial of Pumitamig in combination with Gilead’s (GILD) TROP2-directed ADC sacituzumab govitecan in triple-negative breast cancer (91.29)
- Co announced a clinical trial collaboration and supply agreement with Gilead Sciences (GILD) to evaluate pumitamig in combination with the TROP2-directed antibody-drug conjugate sacituzumab govitecan as first-line treatment for patients with locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer. Pumitamig is an investigational bispecific immunomodulator designed to cooperatively bind to PD-L1 and VEGF-A that is being jointly developed by BioNTech and Bristol Myers Squibb (BMY).
- ROSETTA Breast-01 is a global, double-blinded Phase 3 clinical trial (NCT07173751) currently evaluating pumitamig in combination with chemotherapy versus chemotherapy in patients with locally advanced or metastatic PD-L1 low or negative TNBC (CPS < 10), initiated based on positive results from a global Phase 2 trial. In line with the evolving treatment landscape in this indication, BioNTech and BMS plan to adapt ROSETTA Breast-01 replacing chemotherapy with sacituzumab govitecan, pending regulatory authority approval, to ensure that patients are receiving the latest standard of care treatment.
- Under the terms of the agreement, BioNTech will continue to sponsor and lead the ROSETTA Breast-01 trial. Gilead will supply sacituzumab govitecan for the combination trial.