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2017ASH前瞻:白血病组合疗法显疗效 显著提高总生存期

2017-12-02 药明康德 药明康德

艾伯维(AbbVie)与罗氏(Roche)合作开发的药物Venclexta(venetoclax)曾于2016年获批作为新疗法治疗慢性淋巴性白血病(CLL)。而近期一项研究发现,venetoclax与rituximab联合治疗复发性或难治性(R/R)CLL时效果优于标准疗法。这一结果即将在美国血液学会(ASH)2017年会上公布。 Venetoclax是一款口服且具有高度选择性的强效BCL-

艾伯维(AbbVie)与罗氏(Roche)合作开发的药物Venclexta(venetoclax)曾于2016年获批作为新疗法治疗慢性淋巴性白血病(CLL)。而近期一项研究发现,venetoclax与rituximab联合治疗复发性或难治性(R/R)CLL时效果优于标准疗法。这一结果即将在美国血液学会(ASH)2017年会上公布。

Venetoclax是一款口服且具有高度选择性的强效BCL-2抑制剂,当作为单药治疗R/R CLL时能达到较高的总体缓解率(ORR)。当venetoclax与rituximab联合使用时耐受性良好,并能获得较好的完全缓解(CR)率和微小残留病变阴性(MRD-)。

该药物的疗效在3期临床试验MURANO中得到验证。该试验是一项随机、公开标签的研究,旨在评估venetoclax与rituximab联合治疗与标准化疗相比,在R/R CLL患者中的疗效和安全性。研究的主要终点是研究者评估的无进展生存期(PFS)。

结果显示,接受venetoclax与rituximab联合治疗的患者的PFS优于标准治疗组,中位PFS未达到,而标准治疗组为17个月(HR=0.17, 95%CI: 0.11-0.25, p<0.0001);24个月的PFS率在联合治疗组和标准治疗组中分别为84.9%和36.3%。独立审查委员会评估的PFS与之相似。关键次要疗效终点显示了一致的结果:联合治疗组有显着提高的总生存期(OS)(HR=0.48, 95%CI: 0.25-0.90);研究者评估的ORR在联合治疗组和标准治疗组中分别为93.3%和67.7%;CR率分别为26.8%和8.2%;联合治疗组的外周血MRD-率(83.5%)高于标准治疗组(23.1%)。此外,venetoclax与rituximab联合疗法的安全性与已知该方案的结果一致。

研究者认为,MURANO是R/R CLL研究的首个3期临床研究,显示了相比标准化疗免疫疗法显着提高的PFS,且在所有风险亚组中有一致的结果。关键次要终点(包括OS、ORR和CR率)也显示了一致的改善,同时外周血MRD-率明显超过了以往R/R CLL治疗所能达到的水平。

我们期待在大会上看到这一研究的具体结果,并希望这一新型组合疗法能尽快为患者带来疾病缓解。(生物谷Bioon.com)

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    2017-12-04 kksonne
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    2017-12-04 虈亣靌

    内容丰富.值得学习

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1773061, encodeId=b8291e7306146, content=<a href='/topic/show?id=38b7e76380a' target=_blank style='color:#2F92EE;'>#组合疗法#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=77638, encryptionId=38b7e76380a, topicName=组合疗法)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=81db38453761, createdName=yankaienglish, createdTime=Tue Mar 13 10:32:00 CST 2018, time=2018-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1301199, encodeId=64c01301199f2, content=<a href='/topic/show?id=38e32852fe' target=_blank style='color:#2F92EE;'>#ASH#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2852, encryptionId=38e32852fe, topicName=ASH)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=39a0295, createdName=kksonne, createdTime=Mon Dec 04 13:32:00 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378150, encodeId=0df713e8150fa, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Mon Dec 04 13:32:00 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516011, encodeId=bd1c1516011e7, content=<a href='/topic/show?id=bd0152e64f1' target=_blank style='color:#2F92EE;'>#总生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=69, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52764, encryptionId=bd0152e64f1, topicName=总生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Mon Dec 04 13:32:00 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266744, encodeId=2ed0266e4406, content=内容丰富.值得学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Mon Dec 04 13:28:50 CST 2017, time=2017-12-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=266286, encodeId=6cbb26628679, content=学习一下谢谢, beContent=null, objectType=article, channel=null, level=null, likeNumber=98, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zSn0GqHrsfLGSUSR8zwnWWLT4FMl5XH8S58HuZslVkLsAPbXDXaliagK7TOxQfmngKibG1yrDonepCLDkcxGk8hS/0, createdBy=b8282062892, createdName=changjiu, createdTime=Sat Dec 02 23:12:54 CST 2017, time=2017-12-02, status=1, ipAttribution=)]
    2017-12-02 changjiu

    学习一下谢谢

    0

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