On February 3, 2023, the FDA approved sacituzumab govitecan-hziy (Trodelvy; Gilead Sciences/Immunomedics) for the treatment of patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+ with a negative in situ hybridization test) breast cancer who have received endocrine-based therapy and at least 2 additional systemic therapies in the metastatic setting.
Sacituzumab govitecan was previously approved for the treatment of patients with unresectable, locally advanced or metastatic triple-negative breast cancer who have had at least 2 previous systemic therapies, and for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed cell death 1 or programmed cell death ligand 1 inhibitor.
This new approval was based on results of the TROPiCS-02 study, an open-label, multicenter, randomized clinical trial of 543 patients with unresectable, locally advanced or metastatic HR-positive, HER2-negative breast cancer whose disease progressed after receiving other systemic therapies. Patients were randomized (1:1) to sacituzumab govitecan 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle or single-agent chemotherapy.
The primary efficacy outcome measure was progression-free survival (PFS) as determined by blinded independent central review per RECIST version 1.1. A key secondary efficacy outcome measure was overall survival (OS). Median PFS was 5.5 months (95% confidence interval [CI], 4.2-7.0 months) in the sacituzumab govitecan arm versus 4 months (95% CI, 3.1-4.4 months) in the single-agent chemotherapy arm. Median OS was 14.4 months in the sacituzumab govitecan arm (95% CI, 13.0-15.7 months) versus 11.2 months (95% CI, 10.1-12.7 months) in the single-agent chemotherapy arm.
The most common (≥25%) adverse events, including laboratory abnormalities, were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, increased glucose, constipation, and decreased albumin.
