Sacituzumab govitecan in HR+HER2− metastatic breast cancer: the randomized phase 3 EVER-132-002 trial

作者：Binghe Xu, Shusen Wang, Min Yan, Joohyuk Sohn, Wei Li, Jin-hai Tang, Xiaojia Wang, Ying Wang, Seock‐Ah Im, Dongdong Jiang, T. Valdez, Anandaroop Dasgupta, Yiran Zhang, Yi‐Lin Yan, Kimberly M. Komatsubara, Wei‐Pang Chung, Fei Ma, Ming‐Shen Dai · 发表于：Nature Medicine · 年份：2024 · DOI：10.1038/s41591-024-03269-z · 被引用次数：44 · 研究领域：Cancer Treatment and Pharmacology、Advanced Breast Cancer Therapies、HER2/EGFR in Cancer Research

Sacituzumab govitecan (SG) significantly improved progression-free survival (PFS) and overall survival (OS) versus chemotherapy in hormone receptor-positive human epidermal growth factor receptor 2-negative (HR+HER2−) metastatic breast cancer (mBC) in the global TROPiCS-02 study. TROPiCS-02 enrolled few Asian patients. Here we report results of SG in Asian patients with HR+HER2− mBC from the EVER-132-002 study. Patients were randomized to SG (n = 166) or chemotherapy (n = 165). The primary endpoint was met: PFS was improved with SG versus chemotherapy (hazard ratio of 0.67, 95% confidence interval 0.52–0.87; P = 0.0028; median 4.3 versus 4.2 months). OS also improved with SG versus chemotherapy (hazard ratio of 0.64, 95% confidence interval 0.47–0.88; P = 0.0061; median 21.0 versus 15.3 months). The most common grade ≥3 treatment-emergent adverse events were neutropenia, leukopenia and anemia. SG demonstrated significant and clinically meaningful improvement in PFS and OS versus chemotherapy, with a manageable safety profile consistent with prior studies. SG represents a promising treatment option for Asian patients with HR+HER2− mBC (ClinicalTrials.gov identifier no. NCT04639986 ). In the phase 3 EVER-132-002 trial, patients with HR+HER2− metastatic breast cancer from Asia were treated with the Trop-2-directed antibody–drug conjugate sacituzumab govitecan or chemotherapy, and those receiving sacituzumab govitecan experienced prolonged progression-free survival compared with ...