Gilead has reported that its phase 3 ASCENT-07 trial evaluating Trodelvy (sacituzumab govitecan-hziy) as a first-line treatment for patients with HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS).
Trodelvy is a first-in-class antibody-drug conjugate targeting Trop-2, an antigen highly expressed across multiple tumour types, including approximately 90% of breast and lung cancers. The therapy is currently approved in more than 50 countries for second-line or later treatment of metastatic triple-negative breast cancer (TNBC) and in over 40 countries for previously treated HR+/HER2-negative metastatic breast cancer.
The agent is being evaluated in several ongoing phase 3 trials across TNBC, HR+/HER2-negative breast cancer, and certain lung cancers, both as monotherapy and in combination regimens.
The ASCENT-07 is an ongoing global, open-label, randomised phase 3 trial evaluating the efficacy and safety of Trodelvy compared with chemotherapy as a first-line treatment post-endocrine therapy in patients with HR+/HER2-negative metastatic breast cancer.
ASCENT-07 is a global, open-label, randomised phase 3 study assessing Trodelvy versus physician’s-choice chemotherapy as first-line treatment following endocrine therapy in HR+/HER2-negative metastatic breast cancer. According to Gilead, a Blinded Independent Central Review (BICR) determined that the trial did not achieve its PFS primary endpoint per RECIST v1.1 criteria.
Overall survival (OS) data, a key secondary endpoint, was not mature at the time of analysis. However, Gilead reported early, favourable OS trends among patients receiving Trodelvy, and the study will continue to collect additional survival data.
“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 Dietmar Berger, Chief Medical Officer, Gilead Sciences. “We look forward to sharing the full data of ASCENT-07 at an upcoming medical conference.”