BioNTech and Gilead modify Phase 3 breast‑cancer trial to test pumitamig with Trodelvy
BioNTech announced a partnership with Gilead Sciences to change the ongoing global Phase 3 ROSETTA Breast‑01 study. The protocol will swap standard chemotherapy for Gilead’s antibody‑drug conjugate sacituzumab govitecan (Trodelvy) in patients with advanced triple‑negative breast cancer that have low or negative PD‑L1 expression. BioNTech will keep leading the trial while Gilead will provide the Trodelvy drug, subject to regulatory clearance.
Why it matters
The redesign could affect the trial’s timeline and the competitive landscape for first‑line treatments in this aggressive cancer subtype. Investors in BioNTech and Gilead should watch for regulatory decisions and any subsequent data that may influence future product approvals.
Key facts
- 1The collaboration was announced on 22 October 2026. investing.com
- 2BioNTech will continue to sponsor and lead the ROSETTA Breast‑01 trial. investing.com
- 3Gilead will supply sacituzumab govitecan (Trodelvy) for the combination arm. investing.com
- 4The trial design will replace chemotherapy with Trodelvy pending regulatory approval. investing.com
- 5Pumitamig is a bispecific immunomodulator that binds PD‑L1 and VEGF‑A, co‑developed with Bristol Myers Squibb. investing.com
- 6Triple‑negative breast cancer represents roughly 10‑15 % of all invasive breast cancers. investing.com
Summary written by AlphAI AI Desk from 7 of 7 sources. Not investment advice. Figures are as stated by the linked sources.