BioNTech SE plans a global Phase 3 first-line study of pumitamig with sacituzumab govitecan (Trodelvy) for locally advanced or metastatic triple-negative breast cancer patients whose combined positive score (CPS) is below 10, pending regulatory approval.
The plan, announced Oct. 22, would change the ROSETTA Breast-01 protocol. Gilead Sciences will supply the medicine; BioNTech will remain the trial sponsor and lead.
The current protocol uses a chemotherapy-based comparison. BioNTech’s filing describes pumitamig plus chemotherapy tested against chemotherapy, while the U.K. Health Research Authority’s public summary specifies placebo plus chemotherapy in the control arm. BioNTech plans to put sacituzumab govitecan in place of chemotherapy if regulators approve the change.
The U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan alone on June 24 as first-line treatment for adults with unresectable locally advanced or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor-based treatment. The agency also approved it with pembrolizumab as first-line therapy for adults with the same disease whose tumors score at least 10 on an FDA-authorized test.
The FDA cited the 558-patient ASCENT-03 study in its monotherapy decision. Median progression-free survival was 9.7 months with sacituzumab govitecan and 6.9 months with chemotherapy; the agency said overall-survival data were immature.
BioNTech describes pumitamig as an experimental immune-modulating medicine that targets PD-L1 and VEGF-A, and is developing it with Bristol Myers Squibb. The company says the candidate has not previously been tested alongside an antibody-drug conjugate in a global Phase 3 study. BioNTech said the combination’s safety and effectiveness have not been established. The announcement gave no financial terms or timeline for the protocol amendment, which awaits regulatory approval.
