Gilead Sciences revealed on Friday that the main objective of its Phase 3 ASCENT-07 research, which assessed the medication Trodelvy® (sacituzumab govitecan-hziy) as a first-line treatment for a certain kind of advanced breast cancer, was not achieved.
In patients with HR+/HER2-negative metastatic breast cancer whose condition had worsened following endocrine therapy, the trial examined Trodelvy versus chemotherapy. According to a Blinded Independent Central Review (BICR), the primary goal, progression-free survival (PFS), which measures how long patients lived without their disease getting worse, was not reached.
Although this primary aim was not met, Gilead observed that overall survival (OS), a crucial secondary endpoint, demonstrated a positive “early trend… favouring patients treated with Trodelvy.” In order to obtain more conclusive statistics on overall survival, the ASCENT-07 trial will continue to monitor patients.
Gilead verified that no new safety issues were found and that the safety profile of Trodelvy in this investigation was in line with earlier findings.
Read More: Gilead’s Trodelvy Shows Significant Promise in Treating Aggressive Breast Cancer
Context and Future Outlook
Gilead’s Chief Medical Officer, Dr. Dietmar Berger, highlighted the medication’s proven importance in later-line therapies despite the ASCENT-07 result being a setback for this particular first-line indication.
Many nations have previously approved Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate (ADC), for:
- Adults with metastatic or locally advanced triple-negative breast cancer (mTNBC) that is incurable and has undergone two or more previous systemic treatments.
- Adults with metastatic or locally advanced HR+/HER2-negative breast cancer that is incurable and has undergone at least two more systemic treatments in addition to endocrine-based therapy.
About the ASCENT-07 Study
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654 people from almost 30 countries participated in the global, open-label, randomised Phase 3 ASCENT-07 research. Patients were randomly assigned on a 2:1 basis to receive either Trodelvy or a single-agent chemotherapy treatment (such as capecitabine, paclitaxel, or nab-paclitaxel) of the doctor’s choosing.
Trodelvy’s safety and effectiveness have not been proven in this particular patient population, and its usage as a first treatment for this subtype of breast cancer right after endocrine therapy is still under consideration.
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