多发性骨髓瘤治疗:Kyprolis与Darzalex的组合在III期试验中达到了主要终点

2019-09-14 Allan MedSci原创

Amgen近日公布的III期临床试验(CANDOR研究)结果显示,与单独使用抗癌药物Kyprolis(卡非佐米)联合地塞米松方案相比,Kyprolis与地塞米松联合强生公司的Darzalex(daratumumab)的三药方案治疗复发难治多发性骨髓瘤患者,能够显著延长无进展生存期(PFS)。

Amgen近日公布的III临床试验(CANDOR研究)结果显示,与单独使用抗癌药物Kyprolis(卡非佐米)联合地塞米松方案相比,Kyprolis与地塞米松联合强生公司的Darzalexdaratumumab)的三药方案治疗复发难治多发性骨髓瘤患者,能够显著延长无进展生存期(PFS)。Amgen研发部负责人David Reese表示:“CANDOR研究结果证实了Kyprolis与抗CD38单克隆抗体结合使用的可能性

在该研究中,466例已经接受过一至三次治疗的复发难治性多发性骨髓瘤患者被随机分配到Kyprolis联合Darzalex组或Kyprolis单独治疗组,两者均与地塞米松联合治疗。除了主要终点PFS外,次要目标还包括总体反应率、最小残留病(MRD)和总体存活率。结果显示,与Kyprolis联合地塞米松相比,三药方案将疾病进展或死亡的风险降低了37%。截止报道日期,三药方案尚未达到中位PFS


原始出处:

http://www.firstwordpharma.com/node/1666128#axzz5zU18ApSM

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    2020-08-13 juliusluan78
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    2019-09-16 sunylz
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    2020-03-25 jml2009

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2012年7月20日讯 --  FDA批准Onyx公司药物Kyprolis(carfilzomib)用于先前已接受过至少2种药物治疗但复发(包括Velcade和Thalomid)的多发性骨髓瘤患者的治疗。 多发性骨髓瘤通常生长在骨髓中。骨髓是正常血细胞产生的场所。根据美国癌症协会(ACS),在2012年,预计有21700人将被诊断患有多发性骨髓瘤,10700例患者将死于该病。 "Ky

FDA批准Kyprolis用于骨髓瘤治疗

FDA已经批准蛋白酶抑制剂carfilzomib(Kyprolis)用于接受过其他疗法但效果不佳的多发性骨髓瘤患者的治疗。批准该药用于至少两种已有疗法(其中之一必须为硼替佐米,Velcade)无效的复发性或难治性骨髓瘤患者的治疗。获得FDA加速审批程序1个月后,carfilzomib在肿瘤药物咨询委员会(ODAC)投票表决中得到了11:0(其中1票弃权)的高度认同,成功获得批准。“Kyprolis