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Clinical Overview of Enfortumab Vedotin in the Management of Locally Advanced or Metastatic Urothelial Carcinoma

机译:在局部晚期或转移性尿路上皮癌中临床概述伤害韦特汀

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The treatment landscape for locally advanced or metastatic urothelial carcinoma has broadened significantly over recent years. New therapeutic options include immunotherapy with checkpoint inhibitors and targeted therapy with erdafitinib. Despite these advances, gaps remain in the selection and sequencing of optimal therapies. Treatment decisions are often influenced by several patient-specific factors such as tolerability and biomarker expression. Following progression while receiving front- and second-line therapies, there is no widely accepted standard of care for patients. Enrollment into a clinical trial is recommended in all lines of therapy for advanced disease. Antibody-drug conjugates have recently emerged as novel therapeutics allowing for targeted delivery of chemotherapeutic agents. Enfortumab vedotin, a nectin-4-targeted antibody conjugated with monomethyl auristatin E, is the first-in-class therapeutic option and has demonstrated unprecedented response rates following progression on chemotherapy and immunotherapy for advanced disease with a tolerable safety profile. As a result, a biologics license application was submitted to the US FDA in July 2019. Ongoing clinical trials are aiming to further establish the role of enfortumab vedotin in urothelial carcinoma. In this article, we highlight the safety and efficacy of enfortumab vedotin for patients with advanced bladder cancer, ongoing clinical trials, clinical pharmacology, and pharmacokinetics.
机译:近年来,局部晚期或转移性尿路上皮癌的治疗景观显着扩大。新的治疗选择包括具有检查点抑制剂和靶向治疗的免疫疗法和Erdafitinib。尽管有这些进步,但差距仍然存在于最佳疗法的选择和排序中。治疗决策通常受到几种患者特异性因素的影响,例如耐受性和生物标志物表达。在接受前端和二线疗法的进展之后,患者没有广泛接受的护理标准。在治疗晚期疾病的所有治疗中建议注册临床试验。最近抗体 - 药物缀合物作为新的治疗剂,允许靶向递送化学治疗剂。 Enfortumab Vedotin是一种与单呋秀蛋白E缀合的Nectin-4靶向抗体,是一类阶级治疗选择,并在具有可容忍的安全性曲线的前期疾病的进展过程中显示出前所未有的反应率。因此,将在2019年7月提交给美国FDA的生物学许可证申请。正在进行的临床试验旨在进一步建立危险症患者在尿路上癌中的作用。在本文中,我们突出了Enfortumab Vedotin对晚期膀胱癌,正在进行的临床试验,临床药理学和药代动力学的患者的安全性和有效性。

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