FDA批准Opdivo联合Yervoy治疗恶性胸膜间皮瘤

2020-10-03 Allan MedSci原创

FDA已批准Opdivo(nivolumab)联合Yervoy(ipilimumab)的组合用于成人不可切除的恶性胸膜间皮瘤(MPM)的一线治疗。

恶性胸膜间皮瘤(MPM)是一种罕见肿瘤,通常起源于胸膜腔的间皮表面。间皮瘤也可能起源于腹膜表面、睾丸鞘膜或心包。MPM的预后较差。患者的中位生存期为6-18个月。

Bristol Myers Squibb上周五宣布,FDA已批准Opdivo(nivolumab)联合Yervoy(ipilimumab)的组合用于成人不可切除的恶性胸膜间皮瘤(MPM)的一线治疗。

III期CheckMate-743试验的研究员Anne Tsao指出:“III期CheckMate-743试验的生存数据表明,Opdivo和Yervoy的结合使用可能成为一种新的一线标准护理选择”。

CheckMate-743招募了605例先前未经治疗的不可切除MPM患者。参与者被随机分配为每两周接受一次Opdivo静脉输注,每六周接受一次Yervoy静脉输注,长达两年。主要终点是总生存期(OS)。中期分析的结果表明,在至少22.1个月的随访中,使用Opdivo+Yervoy联合治疗的患者比基于铂的护理标准化疗的生存率更高,中位OS​​分别为18.1个月和14.1个月。

 

原始出处:

https://www.firstwordpharma.com/node/1762545?tsid=4

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    2020-11-29 lifestar
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    2021-02-17 ms3000000788774334

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    2020-10-15 14818eb4m67暂无昵称

    学习

    0

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    2021-07-07 bugit
  5. [GetPortalCommentsPageByObjectIdResponse(id=1666301, encodeId=8244166630123, content=<a href='/topic/show?id=bbaf8420118' target=_blank style='color:#2F92EE;'>#胸膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84201, encryptionId=bbaf8420118, topicName=胸膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fbc026056217, createdName=lifestar, createdTime=Sun Nov 29 16:58:58 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=925002, encodeId=f314925002ab, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210214/43b7543830fd40c1aa4edef9b88f4a28/6267a1fe6d1f48fda6fadce43a290bfb.jpg, createdBy=6cbf5420757, createdName=ms3000000788774334, createdTime=Wed Feb 17 08:03:50 CST 2021, time=2021-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892167, encodeId=405a89216ec3, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Thu Oct 15 08:01:58 CST 2020, time=2020-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839875, encodeId=4d8418398e549, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Jul 07 20:58:58 CST 2021, time=2021-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303102, encodeId=21341303102c2, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13404, encryptionId=4264134043c, topicName=Opdivo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365822, encodeId=ed8b1365822ad, content=<a href='/topic/show?id=5b751895214' target=_blank style='color:#2F92EE;'>#Yervoy#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18952, encryptionId=5b751895214, topicName=Yervoy)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db5b227, createdName=gostraight, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579823, encodeId=ea3315e98233c, content=<a href='/topic/show?id=6db59e28738' target=_blank style='color:#2F92EE;'>#间皮瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97287, encryptionId=6db59e28738, topicName=间皮瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d61a16562641, createdName=1249884fm92暂无昵称, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889860, encodeId=d8398898607e, content=很有趣的研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEIF7OaP2iaaUz8P5M1thS6iaXU2pK86Ria5cPH2ZlX5dficZsehWgia5djJOQJ6RAARfGMvhh4m0RSpDPA/132, createdBy=08931946567, createdName=周哲, createdTime=Sat Oct 03 11:05:23 CST 2020, time=2020-10-03, status=1, ipAttribution=)]
    2020-10-05 119337457
  6. [GetPortalCommentsPageByObjectIdResponse(id=1666301, encodeId=8244166630123, content=<a href='/topic/show?id=bbaf8420118' target=_blank style='color:#2F92EE;'>#胸膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84201, encryptionId=bbaf8420118, topicName=胸膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fbc026056217, createdName=lifestar, createdTime=Sun Nov 29 16:58:58 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=925002, encodeId=f314925002ab, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210214/43b7543830fd40c1aa4edef9b88f4a28/6267a1fe6d1f48fda6fadce43a290bfb.jpg, createdBy=6cbf5420757, createdName=ms3000000788774334, createdTime=Wed Feb 17 08:03:50 CST 2021, time=2021-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892167, encodeId=405a89216ec3, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Thu Oct 15 08:01:58 CST 2020, time=2020-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839875, encodeId=4d8418398e549, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Jul 07 20:58:58 CST 2021, time=2021-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303102, encodeId=21341303102c2, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13404, encryptionId=4264134043c, topicName=Opdivo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365822, encodeId=ed8b1365822ad, content=<a href='/topic/show?id=5b751895214' target=_blank style='color:#2F92EE;'>#Yervoy#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18952, encryptionId=5b751895214, topicName=Yervoy)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db5b227, createdName=gostraight, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579823, encodeId=ea3315e98233c, content=<a href='/topic/show?id=6db59e28738' target=_blank style='color:#2F92EE;'>#间皮瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97287, encryptionId=6db59e28738, topicName=间皮瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d61a16562641, createdName=1249884fm92暂无昵称, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889860, encodeId=d8398898607e, content=很有趣的研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEIF7OaP2iaaUz8P5M1thS6iaXU2pK86Ria5cPH2ZlX5dficZsehWgia5djJOQJ6RAARfGMvhh4m0RSpDPA/132, createdBy=08931946567, createdName=周哲, createdTime=Sat Oct 03 11:05:23 CST 2020, time=2020-10-03, status=1, ipAttribution=)]
    2020-10-05 gostraight
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  8. [GetPortalCommentsPageByObjectIdResponse(id=1666301, encodeId=8244166630123, content=<a href='/topic/show?id=bbaf8420118' target=_blank style='color:#2F92EE;'>#胸膜#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=84201, encryptionId=bbaf8420118, topicName=胸膜)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=fbc026056217, createdName=lifestar, createdTime=Sun Nov 29 16:58:58 CST 2020, time=2020-11-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=925002, encodeId=f314925002ab, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20210214/43b7543830fd40c1aa4edef9b88f4a28/6267a1fe6d1f48fda6fadce43a290bfb.jpg, createdBy=6cbf5420757, createdName=ms3000000788774334, createdTime=Wed Feb 17 08:03:50 CST 2021, time=2021-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=892167, encodeId=405a89216ec3, content=学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=88, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=64245268311, createdName=14818eb4m67暂无昵称, createdTime=Thu Oct 15 08:01:58 CST 2020, time=2020-10-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839875, encodeId=4d8418398e549, content=<a href='/topic/show?id=341ae311ea' target=_blank style='color:#2F92EE;'>#FDA批准#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7311, encryptionId=341ae311ea, topicName=FDA批准)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=30bd35, createdName=bugit, createdTime=Wed Jul 07 20:58:58 CST 2021, time=2021-07-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303102, encodeId=21341303102c2, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13404, encryptionId=4264134043c, topicName=Opdivo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365822, encodeId=ed8b1365822ad, content=<a href='/topic/show?id=5b751895214' target=_blank style='color:#2F92EE;'>#Yervoy#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18952, encryptionId=5b751895214, topicName=Yervoy)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db5b227, createdName=gostraight, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1579823, encodeId=ea3315e98233c, content=<a href='/topic/show?id=6db59e28738' target=_blank style='color:#2F92EE;'>#间皮瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=97287, encryptionId=6db59e28738, topicName=间皮瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d61a16562641, createdName=1249884fm92暂无昵称, createdTime=Mon Oct 05 01:58:58 CST 2020, time=2020-10-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=889860, encodeId=d8398898607e, content=很有趣的研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=97, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/PiajxSqBRaEIF7OaP2iaaUz8P5M1thS6iaXU2pK86Ria5cPH2ZlX5dficZsehWgia5djJOQJ6RAARfGMvhh4m0RSpDPA/132, createdBy=08931946567, createdName=周哲, createdTime=Sat Oct 03 11:05:23 CST 2020, time=2020-10-03, status=1, ipAttribution=)]
    2020-10-03 周哲

    很有趣的研究

    0

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Opdivo联合Yervoy显著延长胸膜间皮瘤患者存活率!

恶性胸膜间皮瘤(MPM)是一种罕见肿瘤,通常起源于胸膜腔的间皮表面。间皮瘤也可能起源于腹膜表面、睾丸鞘膜或心包。MPM的预后较差,患者的中位生存期为6-18个月。

Opdivo与Yervoy的联合未能在晚期黑色素瘤研究中达到所有主要终点

百时美施贵宝近日报道说,一项III期研究比较了PD-1抑制剂Opdivo(nivolumab)和抗CTLA-4抗体Yervoy(ipilimumab)联合治疗某些已切除的高危黑色素瘤患者,但试验结果未能达到其中的一项主要终点。

BMS的PD-1单抗Opdivo联合CTLA-4单抗Yervoy治疗非小细胞肺癌中III期临床成功

百时美施贵宝公司宣布,在CheckMate -9LA这项重要的III期临床试验中,PD-1单抗Opdivo(nivolumab)与低剂量CTLA-4单抗Yervoy(ipilimumab)联合使用,与化学相比治疗晚期非小细胞肺癌患者,该试验达到了总体生存率(OS)的主要终点。

Opdivo联合Yervoy用于先前未治疗的晚期或转移性肾细胞癌患者,在42个月的随访中证明了持续的生存益处

百时美施贵宝公司今天宣布了CheckMate -214三期研究的最新结果,该研究评估了PD-1单抗Opdivo(nivolumab)加CTLA-4单抗Yervoy(ipilimumab)与舒尼替尼的组合在先前未经治疗的晚期或转移性肾细胞癌(RCC)中随访42个月的疗效。

FDA将对PD-1单抗Opdivo联合CTLA-4单抗Yervoy用作非小细胞肺癌的一线治疗,展开优先审查

FDA已经开始对未接受过治疗且没有EGFR或ALK突变的NSCLC患者进行PD-1抑制剂Opdivo(nivolumab)联合BMS低剂量CTLA4抑制剂Yervoy(ipilimumab)进行优先审查,并于5月15日前作出判决。

Opdivo & Yervoy联合疗法在日本寻求治疗不可切除、晚期或复发性非小细胞肺癌

ONO制药和Bristol-Myers Squibb近日宣布,两家公司已提交了Opdivo(nivolumab)联合Yervoy(ipilimumab)治疗不可切除、晚期或复发性非小细胞肺癌(NSCLC)的申请。

拓展阅读

Lancet Oncol:采用EZH2抑制剂Tzemetostat治疗复发/难治性恶性胸膜间皮瘤

Tzemetostat治疗第12周时BAP1失活性恶性胸膜间皮瘤患者的疾病控制率为54%。

Lancet Oncol:采用ADC药物Anetumab ravtansine治疗恶性胸膜间皮瘤的疗效和安全性

Anetumab ravtansine在恶性胸膜间皮瘤患者中显示出了可控的安全性及治疗活性

Thorax:恶性胸膜和腹膜间皮瘤的发病率、治疗和生存率

荷兰恶性间皮瘤发病高峰在2010年左右,目前大部分年龄组发病率呈下降趋势。从2003年开始,全身化疗的使用情况有所增加,这可能会随着时间的推移提高患者的总体生存率。

Br J Cancer:CDK4/6抑制剂在恶性胸膜间皮瘤临床前模型中的疗效分析

恶性胸膜间皮瘤(MPM)是一种进袭性、局部侵袭性且无法治愈的胸膜恶性肿瘤,其发病与工作上接触石棉相关。