The United States Food and Drug Administration has expanded the approval of Trodelvy (sacituzumab govitecan-hziy) to include the treatment of adult patients with recurrent unresectable locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer.(1-3) Trodelvy was initially approved for use in triple negative breast cancer.
About Trodelvy (sacituzumab govitecan (IMMU-132)
Trodelvy is a precision cancer medicine that is designed to deliver a toxic payload directly to cancer cells. The drug is a fusion of an antibody that recognizes a protein expressed by breast cancer cells known as trop2 and the metabolite of an established chemotherapy drug (irinotecan), SN-38. Trop-2 is a calcium signal transducer that drives breast cancer cell growth. SN-38 is the active anti-cancer metabolite of Irinotecan chemotherapy that is 1000 times more active than Irinotecan itself. Trodelvy binds to receptors on breast cancer cells and delivers the SN-38 cancer killing drug directly to the cells.
About Hormone Receptor (HR+) Positive Breast Cancer
The majority of breast cancers are referred to as HR+, meaning their cancer is stimulated to grow from exposure to the female hormones estrogen and/or progesterone. HR+ patients are typically treated with endocrine therapy (sometimes referred to as hormone, or anti-estrogen therapy), which reduces the cancer cells’ exposure to estrogen through varying mechanisms. Endocrine therapy has proven extremely effective in reducing HR-positive cancer growth and spread for extended periods of time however some patients ultimately develop recurrent-refractory disease and new treatments are needed.
The decision to extend approval of Trodelvy for treatment of advanced recurrent HR+ breast cancers was based on data from the phase 3 TROPiCS-02 clinical trial (NCT03901339), which showed that Trodelvy improved survival rates and delayed cancer progression when directly compared with single-agent chemotherapy. Twenty-one percent of Trodelvy treated patients survived without cancer progression one year from beginning treatment compared to only 7% for women treated with chemotherapy.
There are currently very limited options to offer patients after endocrine-based therapy and chemotherapy fail. The TROPiCS-02 trial enrolled patients with hormone receptor–positive, HER2-negative metastatic breast cancer who were previously treated with endocrine therapy, a CDK4/6 inhibitor, and 2 to 4 lines of chemotherapy for metastatic disease.
Reported side effects in the trial were consistent with prior studies of Trodelvy, the most frequent were diarrhea, low blood counts, colitis, and vomiting.
To see a clinically meaningful survival and quality of life benefit for these women is exceptional. Trodelvy will continue to undergo development in combination with other drugs and earlier in the disease course to determine if the benefits reported in advanced patients might provide even greater benefit with the earlier use of Trodelvy.
More Reading: Trodelvy Shows Significant Benefit in Advanced Triple-Negative Breast Cancer
References
- US FDA approves Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. News release. Gilead Sciences. February 3, 2023. Accessed February 3, 2023. https://www.gilead.com/news-and-press/press-room
- Trodelvy. Prescribing Information. 2023. Accessed February 3, 2023. fda.gov/drugs
- Rugo HS, Bardia A, Marme F, et al. Overall survival (OS) results from the phase III TROPiCS-02 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with HR+/HER2- metastatic breast cancer
