By Fineline Cube 
Gilead Sciences Inc. (NASDAQ: GILD) today disclosed that the Phase III ASCENT‑07 study, which compared Trodelvy (sacituzumab govitecan‑hziy) to standard chemotherapy as first‑line therapy after endocrine treatment in hormone‑receptor positive (HR+)/HER2‑negative metastatic breast cancer, did not achieve the primary progression‑free survival (PFS) endpoint as measured by Blinded Independent Central Review (BICR) using RECIST v1.1 criteria.
Key Findings
- PFS Result – Trodelvy was below the predefined PFS target versus chemotherapy (BICR‑RECIST v1.1).
- Overall Survival (OS) – A favorable trend for Trodelvy was observed, but OS data were not mature at the time of the primary analysis.
- Trial Continuation – ASCENT‑07 will continue to collect OS data, which remains a critical secondary endpoint.
Context & Historical Performance
- Trodelvy’s Track Record – Trodelvy is the only globally approved Trop‑2‑directed antibody‑drug conjugate (ADC) to demonstrate overall survival benefit in two metastatic breast cancer settings:
- Pre‑treated HR+/HER2‑negative (IHC 0, 1+, or 2+/ISH‑)
- Second‑line or later metastatic triple‑negative breast cancer (TNBC).
- Prior Positive Phase III Studies – ASCENT‑04 and ASCENT‑03 confirmed Trodelvy’s PFS advantage in first‑line metastatic TNBC, irrespective of PD‑L1 status.
Forward‑Looking Statements
This release contains forward‑looking statements regarding the ASCENT‑07 study, potential regulatory actions, and Gilead’s future plans. Actual outcomes may differ materially.-Fineline Info & Tech