PFS、ORR翻倍,死亡风险降低40%!FDA批准卡博替尼联合Opdivo一线治疗肾癌

2021-01-25 医药魔方 医药魔方

1月22日,Exelixis宣布FDA批准 Cabometyx (卡博替尼) 联合Opdivo(纳武利尤单抗)一线治疗晚期肾细胞癌(RCC)。去年8月,Exelixis向FDA提交了卡博替尼联合纳武利

1月22日,Exelixis宣布FDA批准 Cabometyx (卡博替尼) 联合Opdivo(纳武利尤单抗)一线治疗晚期肾细胞癌(RCC)。去年8月,Exelixis向FDA提交了卡博替尼联合纳武利尤单抗一线治疗晚期RCC的上市申请,FDA采用肿瘤药实时审评(PTOR)和快速通道对该申请进行审评,相比2月20日的PDUFA预定日期提前了1个月。

此项批准主要基于开放标签、多中心、关键III期 CheckMate -9ER研究的数据。结果显示,卡博替尼+纳武利尤单抗(n=323)作为一线疗法相比舒尼替尼(n=328)可使晚期RCC患者PFS翻倍(16.6 vs 8.3个月,HR=0.51, 95% CI 0.41-0.64,p<0.0001),到达了主要终点。另外,卡博替尼+纳武利尤单抗组ORR翻倍(56% vs 27%,p<0.0001),同时显着改善了患者的总生存期(HR=0.6,98.89% CI: 0.40-0.89,p=0.001),两组的中位OS均尚未成熟。在基于国际转移性肾细胞癌数据库联盟(IMDC)风险评分和PD-L1表达水平的亚组分析中也观察到了一致的疗效结果。详细数据曾在9月份召开的ESMO2020大会上公布。

安全性方面,卡博替尼+纳武利尤单抗耐受性良好,安全性概况与既往报道的TKI和IO疗法一线治疗晚期RCC的结果一致。超过20%的最常见不良反应包括腹泻、疲劳、肝毒性、掌底红细胞感觉异常、口腔炎、皮疹、高血压、甲状腺功能减退、肌肉骨骼疼痛、食欲减退、恶心、口吃、腹痛、咳嗽和上呼吸道感染。

RTOR是FDA在2018年开始实施的重大创新性肿瘤新药审批新政策,期望以一种更有效的审批方式让患者尽可能早得获得一种疗效和安全性可靠的突破性治疗药物。RTOR制度需要申请人自己申请,允许申请人在整个临床试验全部完成前就提交申请资料,因此从完成申请到获批可能仅需几周时间。卡博替尼+Opdivo是目前唯一一个可以使PFS和ORR相比舒尼替尼都翻倍且同时可显着改善晚期RCC患者总生存期的联合疗法。此次批准对于这类患者具有里程碑意义。

根据美国癌症协会的2021年最新统计数据,肾癌在美国男性和女性中均是最常见的十大肿瘤之一,其中大约90%是肾细胞癌。如果能够在早期确认,RCC患者的5年生存率较高,但是对于晚期或终末期转移性RCC患者,5年生存率只有大约13%。

肾细胞癌患者中有大约70%从组织学上是属于透明细胞癌。大多数透明细胞RCC肿瘤中的von Hippel-Lindau表达低于正常水平,进而导致MET、AXL、VEGF等蛋白高表达,诱导肿瘤血管生成、增长、侵袭和转移。2021年美国大约有32000例晚期肾癌患者需要系统治疗,全球大约有71000例患者需要系统治疗。

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    2021-06-26 bugit
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    2021-01-29 Mr.d

    学习了哦

    0

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    2021-01-28 ms6000000156981277

    0

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  6. [GetPortalCommentsPageByObjectIdResponse(id=1820710, encodeId=f1731820e10a6, content=<a href='/topic/show?id=0c6a1009105e' target=_blank style='color:#2F92EE;'>#风险降低#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100910, encryptionId=0c6a1009105e, topicName=风险降低)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fd18451, createdName=xre2008, createdTime=Fri Feb 26 06:36:27 CST 2021, time=2021-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839911, encodeId=153d1839911ae, 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=29, 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=Sat Jun 26 06:36:27 CST 2021, time=2021-06-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920996, encodeId=3990920996ce, content=学习了哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200820/a50c79dfbf8443c28d9507e5ed481752/4f3848e242344bd8a14c3db699d30a7b.jpg, createdBy=da5f5248805, createdName=Mr.d, createdTime=Fri Jan 29 12:13:45 CST 2021, time=2021-01-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920690, encodeId=562c920690b4, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1cad5440552, createdName=ms6000000156981277, createdTime=Thu Jan 28 11:11:19 CST 2021, time=2021-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256049, encodeId=641f125604926, content=<a href='/topic/show?id=587f6339050' target=_blank style='color:#2F92EE;'>#死亡风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63390, encryptionId=587f6339050, topicName=死亡风险)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303108, encodeId=cb53130310844, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13404, encryptionId=4264134043c, topicName=Opdivo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448674, encodeId=389314486e436, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590703, encodeId=ba5c1590e03db, content=<a href='/topic/show?id=e31d134e83e' target=_blank style='color:#2F92EE;'>#ORR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13478, encryptionId=e31d134e83e, topicName=ORR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8a7b17846501, createdName=psybestwish, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=)]
    2021-01-27 119337457
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    2021-01-27 jeanqiuqiu
  8. [GetPortalCommentsPageByObjectIdResponse(id=1820710, encodeId=f1731820e10a6, content=<a href='/topic/show?id=0c6a1009105e' target=_blank style='color:#2F92EE;'>#风险降低#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=100910, encryptionId=0c6a1009105e, topicName=风险降低)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fd18451, createdName=xre2008, createdTime=Fri Feb 26 06:36:27 CST 2021, time=2021-02-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839911, encodeId=153d1839911ae, 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=29, 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=Sat Jun 26 06:36:27 CST 2021, time=2021-06-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920996, encodeId=3990920996ce, content=学习了哦, beContent=null, objectType=article, channel=null, level=null, likeNumber=67, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20200820/a50c79dfbf8443c28d9507e5ed481752/4f3848e242344bd8a14c3db699d30a7b.jpg, createdBy=da5f5248805, createdName=Mr.d, createdTime=Fri Jan 29 12:13:45 CST 2021, time=2021-01-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=920690, encodeId=562c920690b4, content=好, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1cad5440552, createdName=ms6000000156981277, createdTime=Thu Jan 28 11:11:19 CST 2021, time=2021-01-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256049, encodeId=641f125604926, content=<a href='/topic/show?id=587f6339050' target=_blank style='color:#2F92EE;'>#死亡风险#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63390, encryptionId=587f6339050, topicName=死亡风险)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=74808, createdName=quxin068, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303108, encodeId=cb53130310844, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13404, encryptionId=4264134043c, topicName=Opdivo)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=fda6311, createdName=119337457, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448674, encodeId=389314486e436, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=42, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590703, encodeId=ba5c1590e03db, content=<a href='/topic/show?id=e31d134e83e' target=_blank style='color:#2F92EE;'>#ORR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13478, encryptionId=e31d134e83e, topicName=ORR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8a7b17846501, createdName=psybestwish, createdTime=Wed Jan 27 08:36:27 CST 2021, time=2021-01-27, status=1, ipAttribution=)]
    2021-01-27 psybestwish

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非肿瘤性肾活检在预测肾细胞癌(RCC)手术后肾功能中的作用研究较少。最近,有研究人员评估了一组RCC患者根治性肾切除术后肾实质组织学对肾功能的影响。

Sci Rep:检测尿液miRNAs诊断透明细胞肾细胞癌

透明细胞肾细胞癌(ccRCC)由于缺乏早期症状,从而使肿瘤发生转移,导致患者生存率急剧下降。

J Immunother Cancer:肥胖会减弱肾癌患者采用抗PD-1免疫治疗的疗效

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盘点:近期肾癌研究进展(二)

肾细胞癌(简称肾癌)是泌尿系统中恶性程度较高的肿瘤,也是最常见的肿瘤之一,又称肾腺癌,占肾恶性肿瘤的80%~90%。据调查,肾细胞癌在我国泌尿生殖系统肿瘤中占第二位,仅次于膀胱肿瘤,占成人恶性肿瘤的2

盘点:近期肾癌研究

肾细胞癌(简称肾癌)是泌尿系统中恶性程度较高的肿瘤,也是最常见的肿瘤之一,又称肾腺癌,占肾恶性肿瘤的80%~90%。据调查,肾细胞癌在我国泌尿生殖系统肿瘤中占第二位,仅次于膀胱肿瘤,占成人恶性肿瘤的2