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徐卫教授：泽布替尼在复发/难治CLL中疗效及安全性均优，有望成为“Best in-class”BTK抑制剂

2019-06-27 佚名 肿瘤资讯

泽布替尼CLL
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2019年6月18日～22日，第15届国际淋巴瘤大会(ICML)在风光旖旎的瑞士·卢加诺(Lugano)隆重举行。目前ICML已成为全球淋巴瘤领域最具影响力的盛会，数千名来自世界各地的淋巴瘤领域专家参加了这次学术盛会。泽布替尼（zanubrutinib）是一种选择性不可逆BTK抑制剂，既往研究已证实可有效抑制BTK，对其他激酶的脱靶抑制作用很小。本次ICML期间，来自江苏省人民医院的徐卫教授受邀针

2019年6月18日～22日，第15届国际淋巴瘤大会(ICML)在风光旖旎的瑞士·卢加诺(Lugano)隆重举行。目前ICML已成为全球淋巴瘤领域最具影响力的盛会，数千名来自世界各地的淋巴瘤领域专家参加了这次学术盛会。泽布替尼（zanubrutinib）是一种选择性不可逆BTK抑制剂，既往研究已证实可有效抑制BTK，对其他激酶的脱靶抑制作用很小。本次ICML期间，来自江苏省人民医院的徐卫教授受邀针对泽布替尼治疗复发／难治慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（R/R CLL/SLL）的BGB-3111-205研究进行了口头发言。

BGB-3111 205研究：泽布替尼在CLL/SLL患者中疗效及安全性均优

BGB-3111-205是一项多中心、开放标签、单臂II期临床研究，共纳入91例R/R-CLL/SLL患者（82例为CLL，9例为SLL），均接受泽布替尼单药治疗，研究的主要终点为IRC判断的总体有效率（ORR），而次要终点为研究者评估的ORR。

截至2018年12月14日，75例患者仍在接受泽布替尼治疗，16例患者退出治疗（7例因疾病进展，8例因毒副反应，1例患者自己撤除同意书退出研究）。经过中位15个月的泽布替尼治疗，研究结果显示：①IRC判断的ORR为84%， 其中部分缓解率（PR）以上的CLL/SLL患者达62%；②中位起效时间为2.7个月，达到≥PR疗效的中位时间为5.5个月；③研究者评估的ORR高达91%，这与IRC判断的ORR结果高度一致；④经过13个月随访，中位无进展生存（PFS）尚未达到，12月PFS率为87%。安全性方面，泽布替尼的不良反应（AEs）发生率较低，较之其他BTK抑制剂具有优势。本研究中，泽布替尼的最常见AEs为血细胞减少症，但需要指出，本研究采用CTCAE标准进行AEs评估，而基于该标准，很多CLL/SLL患者在入组时便已出现血细胞减少。此外，本研究中无任何CLL/SLL患者出现房颤，这显示了泽布替尼的安全性优势。

优化的药物结构造就良好的疗效及安全性

目前，泽布替尼主要针对于R/R-CLL/SLL患者的治疗，具有两大主要特点：①相较于其他BTK抑制剂，泽布替尼在外周血及淋巴结当中具有更高的BTK占有率，并且BTK占有的持续时间很长，该优势在很大程度上保证了泽布替尼的良好疗效；②泽布替尼对于BTK具有高度的选择性，因此与一代BTK抑制剂相比，泽布替尼因脱靶导致的AEs发生率很低，保证了安全性。接下来，在R/R CLL/SLL患者中，泽布替尼将继续进行III期临床研究、与伊布替尼的头对头研究等。此外，泽布替尼还将开展前瞻性、随机对照研究，以探讨在CLL/SLL一线治疗中的价值。

泽布替尼向NMPA递交获批申请，期待惠及更多患者

基于BGB-3111-205研究的结果，百济神州目前已经向国家药品监督管理局(NMPA)递交了泽布替尼的获批申请，以用于R/R CLL/SLL患者的治疗。除了具有良好的疗效，泽布替尼良好的安全性对高龄CLL/SLL患者也是显着的临床优势之一，可惠及更多的CLL/SLL患者。

深耕细作，力求探索出更优化的治疗方案

目前，泽布替尼有两项前瞻性、随机对照研究正在开展，分别为BGB-3111-305和BGB-3111-304研究。其中，BGB-3111-305研究将泽布替尼与伊布替尼进行头对头比较，以评估两种BTK抑制剂对R/R CLL/SLL患者的疗效差异。BGB-3111-304研究则是在初治CLL/SLL患者中将泽布替尼与伊布替尼进行了疗效比较。这体现了泽布替尼在CLL/SLL患者治疗中的地位。

需要指出的是，现有的研究显示，由于泽布替尼具有高度的BTK选择性、脱靶率低，因此作用于ITK等靶点的可能性很小。这一特点可能意味着泽布替尼与CD20单抗联合治疗时，对CD20单抗的干扰性小，进而可能会产生更好的疗效，这也是泽布替尼未来的研究方向之一。

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    2020-04-11 jklm09

    #抑制剂#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1852043, encodeId=cc4e1852043f3, content=<a href='/topic/show?id=f0a254918f0' target=_blank style='color:#2F92EE;'>#抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=54918, encryptionId=f0a254918f0, topicName=抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Sat Apr 11 12:35:00 CST 2020, time=2020-04-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2051399, encodeId=dff12051399bd, content=<a href='/topic/show?id=95f8e042dd' target=_blank style='color:#2F92EE;'>#EST#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7042, encryptionId=95f8e042dd, topicName=EST)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e9a6357, createdName=xiangyuzhou971, createdTime=Fri Nov 29 15:35:00 CST 2019, time=2019-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1297373, encodeId=7c81129e3736c, content=<a href='/topic/show?id=d6b83e724b' target=_blank style='color:#2F92EE;'>#BTK抑制剂#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3772, encryptionId=d6b83e724b, topicName=BTK抑制剂)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1e72268, createdName=zhixianchen, createdTime=Sat Jun 29 01:35:00 CST 2019, time=2019-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1539092, encodeId=c8da153909221, content=<a href='/topic/show?id=6bce3e7106' target=_blank style='color:#2F92EE;'>#BTK#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3771, encryptionId=6bce3e7106, topicName=BTK)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=61d813108447, createdName=fengting7, createdTime=Sat Jun 29 01:35:00 CST 2019, time=2019-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1032205, encodeId=38f61032205de, content=谢谢梅斯提供这么好的信息，学到很多, beContent=null, objectType=article, channel=null, level=null, likeNumber=43, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=内科新手, createdTime=Thu Jun 27 13:35:00 CST 2019, time=2019-06-27, status=1, ipAttribution=)]
    2019-11-29 xiangyuzhou971

    #EST#

    0

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    2019-06-29 zhixianchen

    #BTK抑制剂#

    0

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    2019-06-29 fengting7

    #BTK#

    0

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    2019-06-27 内科新手

    谢谢梅斯提供这么好的信息，学到很多

    0