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

IF 58.7 1区医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Nature Medicine Pub Date : 2024-10-01 DOI:10.1038/s41591-024-03269-z

Binghe Xu, Shusen Wang, Min Yan, Joohyuk Sohn, Wei Li, Jinhai Tang, Xiaojia Wang, Ying Wang, Seock-Ah Im, Dongdong Jiang, Theresa Valdez, Anandaroop Dasgupta, Yiran Zhang, Yilin Yan, Kimberly M. Komatsubara, Wei-Pang Chung, Fei Ma, Ming-Shen Dai

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Abstract

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).

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萨妥珠单抗戈维替康治疗 HR+HER2- 转移性乳腺癌：EVER-132-002 随机三期试验

在全球 TROPiCS-02 研究中，对于激素受体阳性的人表皮生长因子受体 2 阴性（HR+HER2-）转移性乳腺癌（mBC），与化疗相比，萨妥珠单抗戈维替康（SG）能显著改善无进展生存期（PFS）和总生存期（OS）。TROPiCS-02 只招募了少数亚洲患者。在此，我们报告EVER-132-002研究中SG治疗HR+HER2-mBC亚洲患者的结果。患者随机接受 SG（166 人）或化疗（165 人）。研究达到了主要终点：SG与化疗相比，PFS有所改善（危险比为0.67，95%置信区间为0.52-0.87；P=0.0028；中位4.3个月与4.2个月）。SG与化疗相比，OS也有所改善（危险比为0.64，95%置信区间为0.47-0.88；P = 0.0061；中位21.0个月对15.3个月）。最常见的≥3级治疗突发不良事件是中性粒细胞减少、白细胞减少和贫血。与化疗相比，SG明显改善了PFS和OS，且具有临床意义，其安全性与之前的研究一致。对于亚洲的HR+HER2- mBC患者来说，SG是一种很有前景的治疗选择（ClinicalTrials.gov标识符编号：NCT04639986）。

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来源期刊

Nature Medicine 医学-生化与分子生物学

CiteScore

100.90

自引率

0.70%

发文量

525

审稿时长

1 months

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