Phase III TROPiCS-02 study evaluating Trodelvy shows significant results in HR+/HER2- metastatic breast cancer
Gilead Sciences announced statistically significant and clinically meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy
Detailed OS results will be presented at an upcoming medical conference. The safety profile for Trodelvy was consistent with prior studies, and no new safety signals emerged in this patient population.
Gilead has submitted a supplemental Biologics License Application (sBLA) to the FDA. These data will also be shared with health authorities outside the U.S. In June 2022, based on the positive primary results from the TROPiCS-02 study presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)i included a category 2A preferred recommendation for sacituzumab govitecan-hziy for the investigational use in patients with HR+/HER2- advanced breast cancer after prior treatment including endocrine therapy, a CDK4/6 inhibitor and at least two lines of chemotherapy. The TROPiCS-02 study enrolled HR+/HER2- metastatic breast cancer patients, which included patients with HER2-low and IHC 0 status.
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