FDA Approves Sacituzumab Govitecan-hziy in Pre-Treated HR+/HER2– Advanced Breast Cancer

The FDA has granted approval to sacituzumab govitecan-hziy (Trodelvy) for the treatment of patients with unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer in patients who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting, according to a press release from Gilead.¹

The approval of sacituzumab govitecan was supported by data from the phase 3 TROPiCS-02 trial (NCT03901339), where the median overall survival was 14.4 months in the sacituzumab arm vs 11.2 months in the physician’s choice arm (HR, 0.79; 95% CI, 0.65-0.96; P = .02). Additionally, the median progression-free survival was 5.5 months in the sacituzumab arm vs 4.0 months in the physician’s choice arm (HR, 0.66; 95% CI, 0.53-0.83; P = .0003).

“[The approval for sacituzumab govitecan] is tremendous because hormone receptor–positive disease is the most common subtype of breast cancer,” 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, said in an interview with CancerNetwork^® ahead of the approval.

“Having an agent that can not [only] improve the duration of control of disease but actually allow [patients] to live longer is really meaningful; it is so important for patients to have more options for treatment.”

In the TROPiCS-02 trial investigators compared the agent vs chemotherapy among patients previously treated with endocrine therapy, a CDK 4/6 inhibitor, and 2 to 4 lines of chemotherapy. In the trial, sacituzumab govitecan yielded a 34% reduction in the risk of progression or death.²

In the TROPiCS-02 trial, 543 patients were randomly assigned 1:1 to receive 10 mg/kg of sacituzumab (n = 271) intravenously on days 1 and 8 of each cycle, or chemotherapy of physician’s choice (n = 271).

The objective response rate in each respective arm was 21.0% vs 14.0% (P = .03), and the median duration of response was 7.4 months (95% CI, 6.5-8.6) vs 5.6 months (95% CI, 3.8-7.9).

Grade 3 or higher treatment-emergent adverse effects (TEAEs) occurred in 74% of patients in the sacituzumab arm compared with 60% in the chemotherapy arm. In the sacituzumab and chemotherapy arms, respectively, treatment discontinuations due to TEAEs occurred in 6% vs 4% of patients, dose delays occurred in 66% vs 44%, and dose reductions occurred in 33% vs 33%. Serious TEAEs were observed in 28% and 19% of patients in each respective arm.

A total of 2% of patients in the sacituzumab arm experienced TEAEs leading to death compared with no patients in the experimental arm.

References

1. U.S FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead. February 3, 2023. Accessed February 3, 2023. https://bwnews.pr/3Y0bftX
2. U.S. FDA accepts for priority review the supplemental biologics license application for Gilead’s Trodelvy® for pre-treated HR+/HER2- metastatic breast cancer. News Release. Gilead. October 11, 2022. Accessed February 1, 2023. https://bit.ly/3EyYMH5