Dr. Bardia on the FDA Approval of Sacituzumab Govitecan in HR+/HER2– Metastatic Breast Cancer

Aditya Bardia, MD, MPH, attending physician, director, Breast Cancer Research Program, Massachusetts General Hospital; associate professor, Harvard Medical School, discusses the significance of the FDA approval of sacituzumab govitecan-hziy (Trodelvy) in patients with pretreated hormone receptor (HR)–positive, HER2-negative metastatic breast cancer and key data from the phase 3 TROPiCS-02 trial (NCT03901339).

Dr. Bardia on the TROPiCS-02 Patient Population

On February 3, 2023, the FDA approved sacituzumab govitecan for adult patients with HR-positive, HER2-negative metastatic breast cancer who have received at least 2 prior lines of systemic therapy and have endocrine-resistant disease, Bardia says. This approval was based on findings from the TROPiCS-02 trial, which investigated the efficacy and safety of sacituzumab govitecan vs treatment of physician’s choice in this population, which included patients who were refractory to or relapsed after at least 2 and no more than 4 prior chemotherapy regimens for metastatic breast cancer, Bardia explains.

Dr. Bardia on Efficacy Data From TROPiCS-02

In TROPiCS-02, patients who received sacituzumab govitecan had a median progression-free survival (PFS) of 5.5 months vs 4.0 months with single-agent standard chemotherapy, Bardia says. This translated to a 34% reduction in the risk of disease progression or death. The 1-year PFS rates were 21% and 7% with sacituzumab govitecan and chemotherapy, respectively.

The median overall survival (OS) was 14.4 months with sacituzumab govitecan vs 11.2 months with standard chemotherapy, Bardia notes, which translated to a 21% reduction in the risk of death. These improvements in both PFS and OS led to the approval of sacituzumab govitecan in this heavily pretreated population, Bardia explains.

Additionally, the overall response rate was 21% with sacituzumab govitecan vs 14% with chemotherapy, and the clinical benefit rate was 34% in the sacituzumab govitecan arm vs 22% in the chemotherapy arm.

Editor’s Note: Dr. Bardia has consultant/advisory board positions with Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics/Gilead, Sanofi, Daiichi Pharma/Astra Zeneca, Phillips, Eli Lilly, and Foundation Medicine; and has conducted contracted research/received grants from Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics/Gilead, Daiichi Pharma/Astra Zeneca, and Eli Lilly.