Overview of TROPiCS-02 Study of Sacituzumab Govitecan in HR+/HER2- mBC

Sara Tolaney, MD, MPH, associate director of the Susan F. Smith Center for Women’s Cancers; director of Clinical Trials, Breast Oncology; and senior physician at Dana-Farber Cancer Institute, and assistant professor of medicine at Harvard Medical School, discusses sacituzumab govitecan-hziy (Trodelvy) as an effective and safe treatment for patients with hormone receptor (HR)-positive/HER2-negative metastatic breast cancer.

Data from the final overall survival (OS) analysis of TROPiCS-02 (NCT03901339) revealed there to be a confirmed clinically meaningful OS benefit with sacituzumab govitecan vs with single-agent chemotherapy in this patient population, further supporting the FDA approval.

Based on findings from the study, the FDA granted approval to sacituzumab govitecan.

Transcription:

0:10 | TROPiCS-02 is a phase 3 study that compared sacituzumab govitecan to treatment of physicians choice chemotherapy in patients with metastatic hormone receptor-positive disease. Eligible patients were required to have had prior CDK4/6 inhibition, prior endocrine therapy, prior taxane, and also 2 to 4 prior lines of chemotherapy in the metastatic setting, and also needed measurable disease. They were then randomized in a 1:1 fashion to get sacituzumab govitecan given at the standard schedule of 10 mg/kg [intravenously] on days 1 and 8 of a 21 day cycle, or to get treatment of physicians choice chemotherapy. The primary end point was progression-free survival. Key secondary end points did include overall survival and objective response rate.

1:34 | At the time of this analysis, which again is a final exploratory overall survival analysis, there was a median follow-up time of 13 months. At this time, there were about 438 overall survival events. We did see that sacituzumab govitecan did improve overall survival. It was 14.5 months with sacituzumab govitecan compared with 11.2 months with treatment of physicians choice chemotherapy, with a hazard ratio of 0.79, suggesting statistically significant improvements in overall survival, but I think also clinically meaningful differences in overall survival.