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JCO:卵巢癌新药Farletuzumab三期临床试验结果发表,3年前已完成试验,结果阴性

2016-03-29 MedSci MedSci原创

 Farletuzumab是一种人源化的单克隆抗体,其靶点为叶酸受体α。叶酸受体α在卵巢癌中高度表达而在大部分正常组织中并不存在。Farletuzumab目前处于双盲、随机的三期临床试验中,用于治疗对铂敏感性卵巢癌。 符合试验条件的患者是在经过铂-紫杉烷化疗完成后出现首次复发6-24个月。所以的患者均接受卡铂加紫杉醇或者多系紫杉醇(六个循环结合随机分配的测试药物,比例为1:1:

Farletuzumab是一种人源化的单克隆抗体,其靶点为叶酸受体α。叶酸受体α在卵巢癌中高度表达而在大部分正常组织中并不存在。Farletuzumab目前处于双盲、随机的三期临床试验中,用于治疗对铂敏感性卵巢癌。

符合试验条件的患者是在经过铂-紫杉烷化疗完成后出现首次复发6-24个月。所以的患者均接受卡铂加紫杉醇或者多系紫杉醇(六个循环结合随机分配的测试药物,比例为1:1:1,Farletuzumab 1.25mg/kg,2.5mg/kg或者的安慰剂)。单药物测试每周都进行直到疾病进展。主要的结束终点是根据实体瘤反应评价条件确定的无进展生存时间(PFS)。共有1100名女性参与此次研究。她们被随机分组,接受治疗剂量或者安慰剂给药治疗。对于上述给药方案,从最初分析得到的PFS分别为9.5、9.7和9.0个月。单抗组无论是哪一种剂量都和安慰剂对照组没有显著性差异。在预先设定的亚组中,基线CA-125水平不高于正常的上限的三倍。Farletuzumab暴露的亚组分析表明相对于安慰剂,这种单抗有着更好的PFS。试验中最常见的不良事件都是和化疗相关的。
这些研究表明,单抗的两种剂量都可以没有达到主要PFS终点的要求。这为治疗卵巢癌提供的新的药物选择。虽然此项涉及 1100 例患者的研究未达到主要终点,卫材仍希望该单克隆抗体在后续分析中能展现对于某些亚群患者 PFS 的改善。

实际上,2013年,卫材公司(Eisai)研究就完成,但到现在才正式公开发表出来。Farletuzumab(MORAb-003),在用于对铂类敏感的上皮性卵巢癌患者的首次复发治疗的Ⅲ期临床 FAR 131 研究未达到无进展生存期(PFS)的主要观察终点。全球每年约有 14 万人死于卵巢癌,90%的癌变肿瘤往往是因为没有及时确诊。虽然很多患者接受了手术和化疗,但复发仍十分普遍。

原始出处:

Vergote I, Armstrong D, Scambia G, et al. A Randomized, Double-Blind, Placebo-Controlled, Phase III Study to Assess Efficacy and Safety of Weekly Farletuzumab in Combination With Carboplatin and Taxane in Patients With Ovarian Cancer in First Platinum-Sensitive Relapse[J]. Journal of Clinical Oncology, 2016: JCO632596.

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    2017-01-10 snf701207
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    2017-03-11 lidong40
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