BioNTech SE plans to amend global ROSETTA Breast-01, pairing pumitamig with Gilead Sciences’ sacituzumab govitecan for first-line treatment of people with triple-negative breast cancer whose tumors show low or no PD-L1 expression. The planned use covers locally advanced or metastatic disease.
BioNTech announced the proposed change Thursday, Oct. 22. The amendment would put sacituzumab govitecan, sold as Trodelvy, in place of chemotherapy as pumitamig’s partner. The change requires regulatory approval. EconoTimes previously covered BioNTech’s earlier report on the planned combination.
The sources describe the current trial comparison differently. BioNTech’s filing describes pumitamig plus chemotherapy versus chemotherapy, while the U.K. Health Research Authority’s public summary lists placebo plus chemotherapy in the control arm.
BioNTech would continue to sponsor and lead the study, and Gilead would supply the medicine. BioNTech is developing pumitamig with Bristol Myers Squibb and describes it as an experimental medicine that targets PD-L1 and VEGF-A.
BioNTech says ROSETTA Breast-01 would be the first global Phase 3 study to test pumitamig with an antibody-drug conjugate, the class that includes sacituzumab govitecan. The planned combination remains investigational; its safety and efficacy have not been established.
