Update provided on Phase III ASCENT-07 study of Trodelvy (sacituzumab govitecan) in metastatic breast cancer – Gilead Sciences

Gilead Sciences Inc. announced the Phase III ASCENT-07 study investigating Trodelvy (sacituzumab govitecan-hziy) versus chemotherapy as a first-line treatment post-endocrine therapy in HR+/HER2-negative metastatic breast cancer patients did not meet the primary endpoint of progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) according to RECIST v1.1 criteria.

Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend was observed favoring patients treated with Trodelvy compared to chemotherapy. The ASCENT-07 study will continue to further assess overall survival.

The safety profile was consistent with prior Trodelvy breast cancer studies and no new safety signals were identified in this patient population.

The ASCENT-07 study ( NCT05840211.) is a global, open-label, randomized Phase III trial evaluating the efficacy and safety of Trodelvy (sacituzumab govitecan-hziy) compared with treatment of physician’s choice chemotherapy in patients with locally advanced, inoperable, or HR+/HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) 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 either sacituzumab govitecan-hziy (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) or treatment of physician’s choice, which included a choice of single-agent chemotherapy including capecitabine, paclitaxel and nab-paclitaxel. Treatment continued until BICR-verified disease progression or unacceptable toxicity. The primary endpoint of the study is PFS as assessed by BICR according to RECIST v1.1 criteria. Key secondary endpoints include overall survival, objective response rate, quality of life, and safety.

Trodelvy is the only globally approved Trop-2-directed antibody-drug conjugate (ADC) to show meaningful overall survival advantages in two distinct types of metastatic breast cancer: pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer and second-line and later metastatic triple-negative breast cancer (TNBC). Trodelvy is recognized as a Category 1 preferred treatment for both approved indications per the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) and is the only ADC with a European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) rating of 5 for metastatic TNBC and a rating of 4 for HR+/HER2-negative mBC.

“Trodelvy remains a standard of care for pre-treated HR+/HER2-negative metastatic breast cancer based on the demonstrated overall survival results seen in the TROPiCS-02 study,” said Dr.  Dietmar Berger,  Chief Medical Officer, Gilead Sciences. “We are deeply grateful to the patients, their families, advocates, and investigators who continue to contribute to this important research. We look forward to sharing the full data of ASCENT-07 at an upcoming medical conference.”

“HR+/HER2-negative metastatic breast cancer is a highly heterogeneous disease, and this complexity makes it particularly challenging to manage, especially in patients whose disease has already progressed on multiple lines of endocrine therapy,” said  Dr. Hope S. Rugo, ASCENT-07 Principal Investigator, Chief, Division of Breast Oncology, Director of Women’s Cancer Program, City of Hope Comprehensive Cancer Center. “It will be critical that we continue to follow patients for overall survival to better understand the potential impact of sacituzumab govitecan long-term in this treatment setting.”