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

April 2023, Vol 14, No 2

NEW INDICATIONS

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.

Related Articles


Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: