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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Monday, February 6, 2023
On February 3, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative (immunohistochemistry [IHC] 0, IHC 1+, or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Efficacy was evaluated in the phase III TROPiCS-02 trial (ClinicalTrials.gov identifier NCT03901339), a multicenter, open label, randomized study in 543 patients with unresectable locally advanced or metastatic HR-positive, HER2-negative breast cancer whose disease progressed after the following in any setting: a CDK4/6 inhibitor, endocrine therapy, and a taxane. Patients received at least two prior chemotherapies in the metastatic setting (one of which could be in the neoadjuvant or adjuvant setting if recurrence occurred within 12 months).
Patients were randomly assigned (1:1) to sacituzumab govitecan, at 10 mg/kg as an intravenous infusion, on days 1 and 8 of a 21-day cycle (n = 272) or single-agent chemotherapy (n = 271). Single-agent chemotherapy was determined by the investigator before randomization from one of the following choices: eribulin ( n= 130), vinorelbine (n = 63), gemcitabine (n = 56), or capecitabine (n = 22). Randomization was stratified by the following factors: prior chemotherapy regimens for metastatic disease (2 vs. 3–4), visceral metastasis (yes or no), and endocrine therapy in the metastatic setting for at least 6 months (yes or no).
The primary efficacy outcome measure was progression-free survival, determined by a blinded independent central review per Response Evaluation Criteria in Solid Tumors 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) with sacituzumab govitecan and 4 months (95% CI = 3.1–4.4 months) with single-agent chemotherapy (hazard ratio [HR] = 0.661 [95% CI = 0.529–0.826]; P = .0003). Median overall survival was 14.4 months with sacituzumab govitecan (95% CI = 13.0–15.7 months) and 11.2 months (95% CI = 10.1–12.7 months) with single-agent chemotherapy (HR = 0.789 [95% CI = 0.646–0.964]; P = .0200).
The most common adverse events (≥ 25%) in patients treated with sacituzumab govitecan in TROPiCS-02 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.
The recommended dose of sacituzumab govitecan is 10 mg/kg administered as an intravenous infusion once weekly on days 1 and 8 of 21-day treatment cycles until disease progression of unacceptable toxicity.
For more information, view the full prescribing information.
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