November 7, 2025 — Leads & Copy — A Phase 3 study of Trodelvy (sacituzumab govitecan-hziy) as a first-line treatment for HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint, according to Gilead Sciences, Inc.
The ASCENT-07 study investigated Trodelvy versus chemotherapy in patients whose disease had progressed after endocrine therapy. The primary endpoint was progression-free survival (PFS), assessed by Blinded Independent Central Review (BICR) based on RECIST v1.1 criteria. While the primary endpoint was not met, an early trend favoring Trodelvy over chemotherapy was observed for overall survival, a key secondary endpoint. The overall survival data was not mature at the time of the primary analysis, and the study will continue to assess this endpoint.
Hope S. Rugo, MD, ASCENT-07 Principal Investigator, Chief, Division of Breast Oncology, Director of Women’s Cancer Program, City of Hope® Comprehensive Cancer Center, noted the challenges in managing HR+/HER2-negative metastatic breast cancer due to its heterogeneity. Rugo said that it is critical to continue to follow patients for overall survival to better understand the potential long-term impact of sacituzumab govitecan in this treatment setting.
According to Gilead Sciences, the safety profile of Trodelvy in the ASCENT-07 study was consistent with previous breast cancer studies, and no new safety signals were identified in the patient population.
Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences, stated that Trodelvy remains a standard of care for pre-treated HR+/HER2-negative metastatic breast cancer, based on overall survival results from the TROPiCS-02 study. Berger added that Gilead is grateful to the patients, families, advocates, and investigators who contributed to the research. The company anticipates sharing the full data from ASCENT-07 at an upcoming medical conference.
Trodelvy is a Trop-2-directed antibody-drug conjugate (ADC) approved in over 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in over 40 countries for certain pre-treated HR+/HER2-negative metastatic breast cancer patients. It is recognized as a Category 1 preferred treatment for both approved indications by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and has received an ESMO-MCBS rating of 5 for metastatic TNBC and 4 for HR+/HER2-negative mBC.
Trodelvy is also the only ADC to demonstrate a statistically significant and clinically meaningful PFS improvement in first-line metastatic TNBC, regardless of PD-L1 status, in two Phase 3 studies (ASCENT-04 and ASCENT-03) presented earlier in 2025.
Gilead is continuing to explore Trodelvy in multiple disease stages and tumor types, including the Phase 3 ASCENT-05 study in high-risk early-stage TNBC (eTNBC) and additional Phase 3 studies in lung and gynecologic cancers.
The use of Trodelvy as a first treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer and in first-line metastatic TNBC remains investigational, with safety and efficacy not yet established for these uses.
HR+/HER2-negative metastatic breast cancer is the most common subtype, accounting for approximately 70% of cases, or about 400,000 diagnoses annually worldwide. While endocrine therapies can extend survival, most patients eventually progress and develop resistance. Chemotherapy is the primary treatment option after endocrine therapy, but is linked to higher rates of disease resistance and limited clinical outcomes. The need for more effective and better-tolerated options earlier in care is substantial.
The ASCENT-07 study is a global, open-label, randomized Phase 3 trial evaluating Trodelvy versus physician’s choice chemotherapy in patients with locally advanced, inoperable, or HR+/HER2-negative metastatic breast cancer who have received prior endocrine therapy and are candidates for cytotoxic chemotherapy. The study enrolled 654 patients across nearly 30 countries.
Patients were randomized 2:1 to receive sacituzumab govitecan-hziy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or physician’s choice chemotherapy, including capecitabine, paclitaxel, or nab-paclitaxel. Treatment continued until BICR-verified disease progression or unacceptable toxicity.
The primary endpoint was PFS as assessed by BICR according to RECIST v1.1 criteria. Key secondary endpoints included overall survival, objective response rate, quality of life, and safety. More information about ASCENT-07 is available at ClinicalTrials.gov: NCT05840211.
Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate (ADC). Trodelvy is designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This combination delivers activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.
Gilead and Kite Oncology are working to transform how cancer is treated through next-generation therapies, combinations, and technologies to deliver improved outcomes for people with cancer.
Gilead Sciences, Inc. is committed to advancing innovative medicines to prevent and treat life-threatening diseases. In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness, while continuing to invest globally.
U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com.
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Source: Gilead Sciences, Inc.
