Phase III TROPiCS-02 study met the primary endpoint of progression-free survival in late-line HR+/HER2- metastatic breast cancer.- Gilead Sciences

The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy. The trial targeted a 30% reduction in the risk of disease progression or death. The primary endpoint results were consistent with those observed in the Phase 1/II IMMU-132-01 study in a subset of HR+/HER2- metastatic breast cancer patients. The first interim analysis of the key secondary endpoint of overall survival in the TROPiCS-02 study demonstrated a trend in improvement for overall survival. Patients will be followed for a subsequent overall survival analysis. The safety profile for Trodelvy was consistent with prior studies, and no new safety concerns emerged in this patient population.

“HR+/HER2- breast cancer accounts for approximately 70% of all breast cancer cases. Patients with advanced breast cancer may eventually develop endocrine resistance, then resistance to a limited set of sequential chemotherapy options,” said Hope Rugo, MD, Professor of Medicine and Director, Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center. “These data show the potential for Trodelvy to address an important unmet need for patients with HR+/HER2- metastatic breast cancer who have been heavily pretreated.”

Detailed results from TROPiCS-02 will be presented at an upcoming medical conference.