An expert from Dana-Farber Cancer Institute highlights data that supported the FDA’s approval of sacituzumab govitecan for advanced hormone receptor–positive, HER2-negative breast cancer.
Data from the phase 3 TROPiCS-02 trial (NCT03901339) indicated that sacituzumab govitecan (Trodelvy) yielded various improvements in efficacy compared with chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative breast cancer.
CancerNetwork® spoke with Sara M. Tolaney, MD, MPH, chief of the Division of Breast Oncology and associate director of the Susan F. Smith Center for Women’s Cancer at Dana-Farber Cancer Institute, and associate professor of medicine at Harvard Medical School, in Boston, ahead of the FDA’s approval of sacituzumab govitecan about data supporting the agency’s action.1
In the TROPiCS-02 trial, there was a median progression-free survival (PFS) of 5.5 months (95% CI, 4.2-7.0) in the sacituzumab arm compared with 4.0 months (95% CI, 3.1-4.4) in the chemotherapy arm (HR, 0.789; 95% CI, 0.646-0.964; P = .02).2 Additionally, the median overall survival (OS) was 14.4 months vs 11.2 months in each respective cohort (HR, 0.789; 95% CI, 0.646-0.964; P = .02).3
Tolaney noted the value of the improvements made in efficacy among patients treated with sacituzumab. “[The data] makes [sacituzumab] a really attractive agent for this patient population,” she said.
TROPiCS-02 had really explored sacituzumab govitecan in patients who were very heavily pretreated. They had had a prior CDK4/6 inhibitor, they had had a minimum of 2 lines of chemotherapy in the advanced disease setting, and could have received up to 4 lines of chemotherapy, so they had a median of 3 [lines of chemotherapy previously received]. [Patients were] very heavily pretreated, and patients had been randomized to get sacituzumab or to get treatment of physician's choice chemotherapy. What we saw was that sacituzumab not only improved progression-free survival but, in fact, led to statistically significant improvement in overall survival, as well as significant improvement in objective response rate. What we're seeing is that this agent does perform better than chemotherapy in this population all around in terms of response, PFS, and OS. And so I think it makes it a really attractive agent for this patient population.