Enfortumab Vedotin in urothelial cancer.
Enfortumab Vedotin in urothelial cancer.
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DOI：
10.1177/1756287220980192
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发表时间：
2020-01
影响因子：
2
通讯作者：
Sridhar SS
中科院分区：
文献类型：
--
作者：
Alt M;Stecca C;Tobin S;Jiang DM;Sridhar SS
随着免疫检查点抑制剂（ICI）、成纤维细胞生长因子受体（FGFR）抑制剂和最近批准的药物，转移性尿路上皮癌（mUC）一线铂类化疗以外的治疗格局在过去5年中发生了显着变化Enfortumab Vedotin（EV）。EV是一种新型的抗体-药物偶联物（ADC），其将微管破坏剂单甲基澳瑞他汀E（MMAE）递送到含有细胞表面nectin-4受体的细胞内。在mUC中，EV显示出令人鼓舞的反应率，并于2019年12月在铂后和ICI环境中获得美国食品药品监督管理局（FDA）的加速批准。EV通常耐受良好，主要毒性为神经病变、皮疹、脱发和疲劳。值得注意的是，EV也可以施用于肾功能不全患者，这是该患者人群中常见的问题。EV目前正在联合策略和尿路上皮癌的早期疾病环境中进行测试。在这篇综述中，我们将讨论其作用机制，导致FDA批准的临床试验以及正在进行的试验和未来的方向。
The treatment landscape for metastatic urothelial cancer (mUC) beyond first-line platinum-based chemotherapy has changed significantly over the last 5 years with the recent approvals of the immune checkpoint inhibitors (ICIs), fibroblast growth factor receptor (FGFR) inhibitors and most recently Enfortumab Vedotin (EV). EV is a novel antibody–drug conjugate (ADC), that delivers monomethyl auristatin E (MMAE), a microtubule-disrupting agent, inside cells harboring the cell surface nectin-4 receptor. In mUC, EV has shown encouraging response rates and received accelerated approval from the Food and Drug Administration (FDA) in December 2019 in the post-platinum and ICI setting. EV is generally well tolerated, with the main toxicities being neuropathy, skin rash, alopecia and fatigue. Notably EV can also be administered to patients with renal dysfunction, which is commonly a concern in this patient population. EV is now being tested in combination strategies and in earlier disease settings in urothelial cancers. In this review, we will discuss its mechanism of action, clinical trials leading to FDA approval as well as ongoing trials and future directions.
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