Dr Tolaney on Final OS Data From the TROPiCS-02 Trial in HR+/HER2- Breast Cancer

Sara M. Tolaney, MD, MPH, chief, Division of Breast Oncology, Susan F. Smith Center for Women's Cancers, associate director, Susan F. Smith Center for Women's Cancers, senior physician, Dana-Farber Cancer Institute, associate professor of Medicine, Harvard Medical School, discusses key data from a final overall survival (OS) analysis of the phase 3 TROPiCS-02 trial (NCT03901339) in hormone receptor (HR)–positive, HER2-negative breast cancer.

The TROPiCS-02 trial compared the use of sacituzumab govitecan-hziy (Trodelvy) vs investigator's choice of chemotherapy in patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed on prior endocrine therapy and at least 2 systemic therapies in the metastatic setting.

Previously reported data from the primary analysis indicated that the trial met its primary end point of improved progression-free survival (PFS) by showing an increase in median PFS from 4 months with single-agent chemotherapy to 5.5 months with sacituzumab govitecan. In the planned secondary analysis, the agent showed significant OS benefit vs the control, as well as improvements in overall response rate. Results from this trial supported the FDA approval of sacituzumab govitecan for use in this population in February, 2023.

At the 2023 ASCO Annual Meeting, a final exploratory analysis of survival outcomes with sacituzumab govitecan was presented. After 13 months of extended follow-up, results confirmed that sacituzumab govitecan continued to provide both PFS and OS benefit, Tolaney says. Median PFS improved by 1.5 months, and median OS increased by 3.3 months with the regimen vs chemotherapy. Moreover, sacituzumab govitecan improved survival outcomes regardless of a patient’s TROP-2 expression and immunohistochemistry score. Benefits seen were consistent across predefined subgroups. Additional improvements in overall response rate, clinical benefit rate, and duration of response were observed and no new safety signals were noted, Tolaney adds.

Overall, these data confirm the efficacy and safety of this agent for patients with pretreated and endocrine-resistant HR-positive/HER2-negative breast cancer and reinforces its use as a standard-of-care in this space, Tolaney concludes.