J Clin Oncol:Spartalizumab 联合达拉非尼和曲美替尼治疗黑色素瘤的疗效

2022-06-29 MedSci原创 MedSci原创

临床前数据表明,与单独使用达拉非尼加曲美替尼相比,抗程序化死亡受体1抗体加达拉非尼和曲美替尼的组合具有更高的抗肿瘤活性。

临床前数据表明,与单独使用达拉非尼加曲美替尼相比,抗程序化死亡受体1抗体加达拉非尼和曲美替尼的组合具有更高的抗肿瘤活性。这些观察结果得到了转化证据的支持,表明免疫检查点抑制剂加上靶向治疗可能会改善BRAF V600突变型转移性黑色素瘤患者的治疗效果。COMBI-i是一项评估spartalizumab(一种抗程序化死亡受体1抗体)与达拉非尼和曲美替尼(sparta-DabTram)联合治疗,vs. 安慰剂加达拉非尼和曲美替尼(安慰剂-DabTram)治疗BRAF V600突变的不可切除或转移性黑色素瘤患者的III期试验。

患者接受每4周一次的spartalizumab 400 mg静脉注射,加上达拉非尼150 mg口服,每天两次,曲美替尼2 mg口服,每天一次或安慰剂-DabTram。参与者年龄≥18岁,患有不可切除或转移性BRAF V600突变的黑色素瘤。主要终点是研究者评估的无进展生存期。总生存期是其中一个关键的次要终点。

结果,在数据截止时(2020年7月1日),Sparta-DabTram组的中位无进展生存期为16.2个月(95%CI,12.7至23.9个月),而安慰剂-DabTram组为12.0个月(95%CI,10.2至15.4个月)(HR,0.82[95%CI,0.66至1.03];P=0.042[单侧;不显著])。客观反应率分别为69%(267名患者中的183名)和64%(265名患者中的170名)。Sparta-DabTram治疗组有55%的患者(267人中的146人)发生≥3级治疗相关的不良事件,安慰剂-DabTram治疗组有33%的患者(264人中的88人)发生。

综上所述,该研究没有达到其主要终点;这些结果不支持Sparta-DabTram的广泛一线使用。进一步的生物标志物驱动的调查可能会确定那些可以从检查点抑制剂加靶向治疗组合中获益的患者亚群。

原始出处:

Reinhard Dummer, et al., Randomized Phase III Trial Evaluating Spartalizumab Plus Dabrafenib and Trametinib for BRAF V600-Mutant Unresectable or Metastatic Melanoma. J Clin Oncol. 2022 May 1;40(13):1428-1438. doi: 10.1200/JCO.21.01601.

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    2022-07-31 minlingfeng
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    2022-12-19 snf701207
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    2022-10-15 gostraight
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    2023-05-19 sunylz
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    2022-06-17 zhaojie88
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  7. [GetPortalCommentsPageByObjectIdResponse(id=1866653, encodeId=5c611866653d3, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sun Jul 31 20:57:28 CST 2022, time=2022-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912873, encodeId=4cfc19128e391, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=53, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Mon Dec 19 03:57:28 CST 2022, time=2022-12-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1989470, encodeId=b55f19894e0ba, content=<a href='/topic/show?id=7033165e692' target=_blank style='color:#2F92EE;'>#SpA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16576, encryptionId=7033165e692, topicName=SpA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db5b227, createdName=gostraight, createdTime=Sat Oct 15 05:57:28 CST 2022, time=2022-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680813, encodeId=e965168081363, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Fri May 19 06:57:28 CST 2023, time=2023-05-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1357937, encodeId=3cdd135e93721, content=<a href='/topic/show?id=b0702e84b9' target=_blank style='color:#2F92EE;'>#ART#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2784, encryptionId=b0702e84b9, topicName=ART)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Fri Jun 17 04:57:28 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1413146, encodeId=392a141314625, content=<a href='/topic/show?id=578993933d0' target=_blank style='color:#2F92EE;'>#达拉非尼#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93933, encryptionId=578993933d0, topicName=达拉非尼)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f31c2942374, createdName=zhangjiqing, createdTime=Fri Jun 17 04:57:28 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559140, encodeId=b5ce1559140b0, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Fri Jun 17 04:57:28 CST 2022, time=2022-06-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565149, encodeId=8eca15651497c, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Fri Jun 17 04:57:28 CST 2022, time=2022-06-17, status=1, ipAttribution=)]
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