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JAMA Oncol：BMS-986156单药或联合纳武单抗治疗晚期实体肿瘤

2019-11-21 QQY MedSci原创

BMS-986156纳武单抗实体肿瘤
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多种免疫刺激激动剂抗体已在实体肿瘤中进行临床试验，以评估靶向糖皮质激素诱导的肿瘤坏死因子(TNF)受体相关蛋白在抗癌治疗中的作用。研究人员开展一全球的、非盲的、1/2a期研究，评估全人糖皮质激素诱导的TNF受体相关蛋白激动剂IgG1单克隆抗体BMS-986156联合或不联合纳武单抗用于晚期实体肿瘤患者的活性和安全性。招募了292位年满18岁的晚期实体瘤患者，ECOG表现状态评分0或1分。单药组：予

多种免疫刺激激动剂抗体已在实体肿瘤中进行临床试验，以评估靶向糖皮质激素诱导的肿瘤坏死因子(TNF)受体相关蛋白在抗癌治疗中的作用。

研究人员开展一全球的、非盲的、1/2a期研究，评估全人糖皮质激素诱导的TNF受体相关蛋白激动剂IgG1单克隆抗体BMS-986156联合或不联合纳武单抗用于晚期实体肿瘤患者的活性和安全性。招募了292位年满18岁的晚期实体瘤患者，ECOG表现状态评分0或1分。单药组：予以蛋白激动剂BMS-986156，10、30、100、240或800mg/2周，静脉注射；联合组：予以BMS-986156 30、100、240或800mg+纳武单抗 240mg/2周。一个队列还每4周接受480mg BMS-986156和480mg 纳武单抗。主要结点是安全性、耐受性和剂量限制性毒性。次要结点为抗肿瘤活性。

随访了1.4-101.7周（仍在随访中），34位患者（中位年龄56.6岁，16位女性）接受单药治疗（4位完成初始治疗），258位患者（中位年龄60岁，140位女性）接受联合治疗（65位完成了初始治疗）。BMS-986156单药治疗组无3-5级治疗相关副作用事件；联合组有24位（9.3%）患者发生3-4级治疗相关副作用事件，无5级治疗相关副作用。每2周接受800mg BMS-986156+240mg 纳武单抗治疗的患者发生了一例剂量限制性毒性作用；无论是否联合了纳武单抗，BMS-986156在单次给药后均表现出剂量相关性增加的线性的药代动力学。无论是否联合了纳武单抗，BMS-986156注射后外周T细胞和自然杀伤细胞的增殖均增强。未观察到肿瘤内CD8+T细胞和FoxP3+调节性T细胞的一致且显著的调节。仅采用BMS-986156治疗的患者未获得任何缓解；联合组的客观缓解率在0-11.1%，在既往采用抗程序性死亡受体1疗法治疗过的患者中观察到一些缓解。

本研究表明BMS-986156的安全性可控，BMS-986156联合纳武单抗的安全性和疗效可媲美既往纳武单抗单药治疗的相关数据。

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  1. [GetPortalCommentsPageByObjectIdResponse(id=1754579, encodeId=77df1e54579e9, content=<a href='/topic/show?id=627a5982254' target=_blank style='color:#2F92EE;'>#晚期实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59822, encryptionId=627a5982254, topicName=晚期实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=333936755048, createdName=30397616, createdTime=Wed Dec 18 23:25:00 CST 2019, time=2019-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865744, encodeId=97ae1865e442f, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Oct 27 20:25:00 CST 2020, time=2020-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378675, encodeId=e32513e86756c, content=<a href='/topic/show?id=f238358866' target=_blank style='color:#2F92EE;'>#BMS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3588, encryptionId=f238358866, topicName=BMS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512d422, createdName=canlab, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379167, encodeId=e8c613e916733, content=<a href='/topic/show?id=49ed460213b' target=_blank style='color:#2F92EE;'>#实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46021, encryptionId=49ed460213b, topicName=实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c77441, createdName=weiz, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035804, encodeId=9641103580492, content=顶刊就是顶刊，谢谢梅斯带来这么高水平的研究报道，我们科里同事经常看梅斯，分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037944, encodeId=0775103e94416, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2019-12-18 30397616

    #晚期实体肿瘤#

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=1754579, encodeId=77df1e54579e9, content=<a href='/topic/show?id=627a5982254' target=_blank style='color:#2F92EE;'>#晚期实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59822, encryptionId=627a5982254, topicName=晚期实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=333936755048, createdName=30397616, createdTime=Wed Dec 18 23:25:00 CST 2019, time=2019-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865744, encodeId=97ae1865e442f, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Oct 27 20:25:00 CST 2020, time=2020-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378675, encodeId=e32513e86756c, content=<a href='/topic/show?id=f238358866' target=_blank style='color:#2F92EE;'>#BMS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3588, encryptionId=f238358866, topicName=BMS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512d422, createdName=canlab, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379167, encodeId=e8c613e916733, content=<a href='/topic/show?id=49ed460213b' target=_blank style='color:#2F92EE;'>#实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46021, encryptionId=49ed460213b, topicName=实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c77441, createdName=weiz, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035804, encodeId=9641103580492, content=顶刊就是顶刊，谢谢梅斯带来这么高水平的研究报道，我们科里同事经常看梅斯，分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037944, encodeId=0775103e94416, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2020-10-27 minlingfeng

    #Oncol#

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=1754579, encodeId=77df1e54579e9, content=<a href='/topic/show?id=627a5982254' target=_blank style='color:#2F92EE;'>#晚期实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59822, encryptionId=627a5982254, topicName=晚期实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=333936755048, createdName=30397616, createdTime=Wed Dec 18 23:25:00 CST 2019, time=2019-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865744, encodeId=97ae1865e442f, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Oct 27 20:25:00 CST 2020, time=2020-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378675, encodeId=e32513e86756c, content=<a href='/topic/show?id=f238358866' target=_blank style='color:#2F92EE;'>#BMS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3588, encryptionId=f238358866, topicName=BMS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512d422, createdName=canlab, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379167, encodeId=e8c613e916733, content=<a href='/topic/show?id=49ed460213b' target=_blank style='color:#2F92EE;'>#实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46021, encryptionId=49ed460213b, topicName=实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c77441, createdName=weiz, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035804, encodeId=9641103580492, content=顶刊就是顶刊，谢谢梅斯带来这么高水平的研究报道，我们科里同事经常看梅斯，分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037944, encodeId=0775103e94416, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2019-11-23 canlab

    #BMS#

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1754579, encodeId=77df1e54579e9, content=<a href='/topic/show?id=627a5982254' target=_blank style='color:#2F92EE;'>#晚期实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59822, encryptionId=627a5982254, topicName=晚期实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=333936755048, createdName=30397616, createdTime=Wed Dec 18 23:25:00 CST 2019, time=2019-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865744, encodeId=97ae1865e442f, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Oct 27 20:25:00 CST 2020, time=2020-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378675, encodeId=e32513e86756c, content=<a href='/topic/show?id=f238358866' target=_blank style='color:#2F92EE;'>#BMS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3588, encryptionId=f238358866, topicName=BMS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512d422, createdName=canlab, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379167, encodeId=e8c613e916733, content=<a href='/topic/show?id=49ed460213b' target=_blank style='color:#2F92EE;'>#实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46021, encryptionId=49ed460213b, topicName=实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c77441, createdName=weiz, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035804, encodeId=9641103580492, content=顶刊就是顶刊，谢谢梅斯带来这么高水平的研究报道，我们科里同事经常看梅斯，分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037944, encodeId=0775103e94416, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2019-11-23 weiz

    #实体肿瘤#

    0

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    2019-11-21 旺医

    顶刊就是顶刊，谢谢梅斯带来这么高水平的研究报道，我们科里同事经常看梅斯，分享梅斯上的信息

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1754579, encodeId=77df1e54579e9, content=<a href='/topic/show?id=627a5982254' target=_blank style='color:#2F92EE;'>#晚期实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59822, encryptionId=627a5982254, topicName=晚期实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=333936755048, createdName=30397616, createdTime=Wed Dec 18 23:25:00 CST 2019, time=2019-12-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865744, encodeId=97ae1865e442f, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=20, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Tue Oct 27 20:25:00 CST 2020, time=2020-10-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378675, encodeId=e32513e86756c, content=<a href='/topic/show?id=f238358866' target=_blank style='color:#2F92EE;'>#BMS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3588, encryptionId=f238358866, topicName=BMS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512d422, createdName=canlab, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1379167, encodeId=e8c613e916733, content=<a href='/topic/show?id=49ed460213b' target=_blank style='color:#2F92EE;'>#实体肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=46021, encryptionId=49ed460213b, topicName=实体肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1c77441, createdName=weiz, createdTime=Sat Nov 23 11:25:00 CST 2019, time=2019-11-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1035804, encodeId=9641103580492, content=顶刊就是顶刊，谢谢梅斯带来这么高水平的研究报道，我们科里同事经常看梅斯，分享梅斯上的信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=旺医, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1037944, encodeId=0775103e94416, content=谢谢梅斯分享这么多精彩信息, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=anti-cancer, createdTime=Thu Nov 21 23:25:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2019-11-21 anti-cancer

    谢谢梅斯分享这么多精彩信息

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