Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design
Bemarituzumab with modified FOLFOX6 for advanced FGFR2-positive gastroesophageal cancer: FIGHT Phase III study design
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DOI：
10.2217/fon-2019-0141
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发表时间：
2019-06-01
期刊：
影响因子：
3.3
通讯作者：
Wainberg, Zev
中科院分区：
文献类型：
--
作者：
Catenacci, Daniel V. T.;Tesfaye, Anteneh;Wainberg, Zev
Bemarituzumab是一种抗FGFR2b(一种成纤维细胞生长因子受体)的果糖基化单抗，在肿瘤过度表达FGFR2b(NCT02318329)的晚期胃癌患者中具有单一治疗临床活性。我们描述了Fight试验(NCT03343301)的基本原理和设计，这是一项全球性、随机、双盲、安慰剂对照的III期研究，评估了bemarituzumab在以前未经治疗的FGFR2b过表达的晚期胃食道癌患者中的作用。患者被随机分成mFOLFOX6和bemarituzumab或mFOLFOX6和安慰剂的组合。符合条件的患者是根据免疫组织化学确定的FGFR2b蛋白过度表达或循环肿瘤DNA确定的FGFR2基因扩增情况来选择的。主要终点是总体生存，次要终点包括无进展生存率、客观有效率和安全性。
Bemarituzumab is an afucosylated monoclonal antibody against FGFR2b (a FGF receptor) with demonstrated monotherapy clinical activity in patients with late-line gastric cancer whose tumors overexpress FGFR2b (NCT02318329). We describe the rationale and design of the FIGHT trial (NCT03343301), a global, randomized, double-blind, placebo-controlled Phase III study evaluating the role of bemarituzumab in patients with previously untreated, FGFR2b-overexpressing advanced gastroesophageal cancer. Patients are randomized in a blinded fashion to the combination of mFOLFOX6 and bemarituzumab or mFOLFOX6 and placebo. Eligible patients are selected based on the presence of either FGFR2b protein overexpression determined by immunohistochemistry or FGFR2 gene amplification determined by circulating tumor DNA. The primary end point is overall survival, and secondary end points include progression-free survival, objective response rate and safety.