Gilead Sciences has announced its Phase 3 ASCENT-07 study evaluating Trodelvy (sacituzumab govitecan-hziy) as a first-line treatment after endocrine therapy in patients with HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). 

 

While the trial fell short of demonstrating a statistically significant PFS benefit compared to chemotherapy, early data suggest a potential overall survival advantage favoring Trodelvy, with follow-up analyses ongoing.

 

“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 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.”

 

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

 

“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,” Dietmar Berger, Chief Medical Officer, Gilead Sciences, said in a statement.

 

“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.”

 

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).

 

The ASCENT-07 study is a global, open-label, randomised Phase 3 trial evaluating the efficacy and safety of Trodelvy. The study enrolled 654 patients across nearly 30 countries.