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Trodelvy Now Approved for Pretreated Patients with HR-Positive, HER2-Negative Breast Cancer

March 2023, Vol 13, No 3

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 PD-1 or PD-L1 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 as determined by blinded independent central review per RECIST version 1.1. A key secondary efficacy outcome measure was overall survival. Median progression-free survival 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 overall survival 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 with sacituzumab govitecan in the TROPiCS-02 trial, including laboratory abnormalities, were decreased leukocyte count (88%), decreased neutrophil count (83%), decreased hemoglobin (73%), decreased lymphocyte count (65%), diarrhea (62%), fatigue (60%), nausea (59%), alopecia (48%), increased glucose (37%), constipation (34%), and decreased albumin (32%).

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