BioNTech and Gilead plan pivotal breast cancer combination study

BioNTech ($BNTX) and Gilead ($GILD) entered a collaboration and supply agreement to study pumitamig with Trodelvy in advanced triple-negative breast cancer. BioNTech plans to modify its Phase 3 ROSETTA-Breast-01 trial, replacing chemotherapy with Gilead's antibody-drug conjugate for patients with previously untreated, locally advanced or metastatic disease and low or absent PD-L1 expression.

The change requires regulatory approval. BioNTech would remain the trial sponsor and lead the study, while Gilead supplies Trodelvy. Pumitamig is a PD-L1/VEGF-A bispecific antibody jointly developed by BioNTech and Bristol Myers Squibb ($BMY); BMY therefore has indirect exposure through that existing development partnership. The collaboration broadens the program's combination strategy, but no efficacy result or approval for this regimen has been announced, and financial terms were not disclosed.

Sources:

• biontech.com
• Reuters