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

Autor: Xu, Binghe, Wang, Shusen, Yan, Min, Sohn, Joohyuk, Li, Wei, Tang, Jinhai, Wang, Xiaojia, Wang, Ying, Im, Seock-Ah, Jiang, Dongdong, Valdez, Theresa, Dasgupta, Anandaroop, Zhang, Yiran, Yan, Yilin, Komatsubara, Kimberly M., Chung, Wei-Pang, Ma, Fei, Dai, Ming-Shen
Zdroj: Nature Medicine; December 2024, Vol. 30 Issue: 12 p3709-3716, 8p
Abstrakt: 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).
Databáze: Supplemental Index