Opdivo(nivolumab)联合Cabometyx(cabozantinib)一线治疗晚期肾细胞癌,CHMP持积极意见

2021-02-27 Allan MedSci原创

Opdivo(nivolumab)联合Cabometyx(cabozantinib)组患者的无进展生存期(PFS)、总生存期(OS)和客观缓解率(ORR)均得到了显著改善。

Bristol Myers Squibb今天宣布,欧洲药品管理局(EMA)人用药品委员会(CHMP)已建议批准将Opdivo®(nivolumab)与Cabometyx®(cabozantinib)结合使用一线治疗晚期肾细胞癌(RCC)。

Bristol Myers Squibb泌尿生殖系统癌症发展计划负责人Dana Walker表示:“近年来,肾细胞癌治疗领域发生了转变,许多进步帮助改善了患者预后”。

CHMP的积极意见来自于CheckMate-9ER III期试验的积极结果。结果显示,与舒尼替尼相比,Opdivo(nivolumab)联合Cabometyx(cabozantinib)组患者的无进展生存期(PFS)、总生存期(OS)和客观缓解率(ORR)均得到了显著改善。Opdivo联合Cabometyx的耐受性良好。

CheckMate-9ER是一项开放标签、随机、多中心III期临床试验,旨在评估Opdivo联合Cabometyx在初治晚期或转移性肾细胞癌(RCC)患者中的有效性和安全性。共计招募了651例患者,其中323例患者被随机分配至Opdivo/Cabometyx联合治疗组,328被随机分配至舒尼替尼组。主要终点是无进展生存期(PFS);次要终点包括总生存期(OS)和客观反应率(ORR)。

 

原始出处:

https://www.firstwordpharma.com/node/1804534?tsid=4

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encodeId=d8581530323e2, content=<a href='/topic/show?id=733a395650' target=_blank style='color:#2F92EE;'>#cabozantinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3956, encryptionId=733a395650, topicName=cabozantinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a95b12086600, createdName=zhao4620, createdTime=Mon Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598105, encodeId=e1671598105f9, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1762, encryptionId=6c6f1e62c5, topicName=ABO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b6c918580135, createdName=闆锋旦, createdTime=Mon Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=)]
    2022-01-31 一闲
  5. 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encodeId=d8581530323e2, content=<a href='/topic/show?id=733a395650' target=_blank style='color:#2F92EE;'>#cabozantinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3956, encryptionId=733a395650, topicName=cabozantinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a95b12086600, createdName=zhao4620, createdTime=Mon Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598105, encodeId=e1671598105f9, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1762, encryptionId=6c6f1e62c5, topicName=ABO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b6c918580135, createdName=闆锋旦, createdTime=Mon Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=)]
    2021-03-01 医生2394
  6. 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encodeId=d8581530323e2, content=<a href='/topic/show?id=733a395650' target=_blank style='color:#2F92EE;'>#cabozantinib#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3956, encryptionId=733a395650, topicName=cabozantinib)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a95b12086600, createdName=zhao4620, createdTime=Mon Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598105, encodeId=e1671598105f9, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1762, encryptionId=6c6f1e62c5, topicName=ABO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b6c918580135, createdName=闆锋旦, createdTime=Mon Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=)]
    2021-03-01 119337457
  7. 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Mar 01 02:22:05 CST 2021, time=2021-03-01, status=1, ipAttribution=)]
  8. 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    2021-03-01 闆锋旦

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