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The phase 3 trial TROPiCS-02 shows that the antibody-drug conjugate is safe and effective in heavily treated metastatic breast cancer with limited treatment options
A new study recently published in The Lancet demonstrated statistically significant and clinically meaningful benefit of sacituzumab govitecan in overall survival over chemotherapy, with a manageable safety profile, in endocrine-resistant, hormone-receptor positive and HER2 negative metastatic breast cancer patients.
The TROPiCS-02 study is a randomized, open-label, multicentre, phase 3 trial where patients with ER+/HER2- locally recurrent inoperable or metastatic breast cancer with limited treatment options were randomly assigned to receive sacituzumab govitecan or chemotherapy. Sacituzumab govitecan is a first-in-class antibody–drug conjugate with an SN-38 payload (the active metabolite of the topoisomerase inhibitor irinotecan) targeted to trophoblast cell-surface antigen 2 (Trop-2), a transmembrane calcium signal transducer highly expressed in breast cancer, linked to poor prognosis. Sacituzumab govitecan is approved in several countries for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received at least two previous systemic therapies and previous results of TROPiCS-02 trial have shown a significant progression-free survival benefit over chemotherapy in ER+/HER2- metastatic breast cancer. New data show, after a 12.5 months median follow-up, an overall survival significantly improved with sacituzumab govitecan versus chemotherapy (median 14.4 months vs 11.2 months), with a benefit consistent across Trop-2 expression-level subgroups. Objective response rate was significantly improved with sacituzumab govitecan compared with chemotherapy as was time to deterioration of global health status, quality of life and fatigue; moreover, the safety profile of sacituzumab govitecan was consistent with previous studies. «These results demonstrate that sacituzumab govitecan is an effective and safe treatment for patients with pretreated, endocrine-resistant HR+ and HER2– metastatic breast cancer, providing a new therapeutic choice for patients with limited treatment options», authors conclude. Based on these analyses, sacituzumab govitecan was approved in the USA in February, 2023, and in the EU in July, 2023, for patients with unresectable locally advanced or metastatic HR+ and HER2– breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.