FDA批准Opdivo联合Cabometyx用于治疗晚期肾细胞癌

2021-01-24 Allan MedSci原创

与单独使用Sutent相比,Opdivo联合Cabometyx还将死亡风险显著降低了40%。

美国食品药品监督管理局(FDA)近日表示,已批准百时美施贵宝的抗PD-1抗体Opdivo(nivolumab)和Exelixis的酪氨酸激酶抑制剂Cabometyx(cabozantinib)联合用于晚期肾细胞癌(RCC)患者的一线治疗。

该决定得到了CheckMate-9ER III期试验的数据支持,该试验评估了相比于辉瑞的Sutent(sunitinib),Opdivo联合Cabometyx在先前未治疗的晚期或转移性RCC患者中的有效性。在2020年欧洲医学肿瘤学会(ESMO)上发表的研究结果表明,中位随访18.1个月之后,Opdivo联合Cabometyx组患者的无进展生存期为16.6个月,而Sutent组患者的无进展生存期仅为8.3个月。与单独使用Sutent相比,Opdivo联合Cabometyx还将死亡风险显著降低了40%。

肾细胞癌(RCC)是一种肾癌(kidney cancer),它产生于肾脏内小的黏膜。一般情况下,一个肿瘤以单个形式生长,但有时,单侧或双侧肾脏内都可能出现不止一个肿瘤。肾细胞癌是成人肾癌里最常见的类型,对50岁到70岁的男性往往影响最大。

 

原始出处:

https://www.firstwordpharma.com/node/1793934?tsid=4

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    2021-03-19 一闲
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    2021-09-29 bugit
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    2021-01-26 Ye.

    纳武利尤单抗联合卡博替尼治疗转移性晚期RCC

    0

  5. 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    2021-01-26 119337457
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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919432, encodeId=a3879194326a, content=1, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=d2fc5455343, createdName=ms1000001433472600, createdTime=Sun Jan 24 12:22:47 CST 2021, time=2021-01-24, status=1, ipAttribution=)]
    2021-01-26 闆锋旦
  8. 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    2021-01-24 lovetcm

    Opdivo联合Cabometyx在先前未治疗的晚期或转移性RCC患者中的有效性。在2020年欧洲医学肿瘤学会(ESMO)上发表的研究结果表明,中位随访18.1个月之后,Opdivo联合Cabometyx组患者的无进展生存期为16.6个月。OS可能会达到40个月了,部分患者可能长期获益

    0

  9. 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objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59875, encryptionId=09a6598e57a, topicName=晚期肾细胞癌)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=87304889998, createdName=12498c24m70暂无昵称, createdTime=Tue Jan 26 02:43:42 CST 2021, time=2021-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1598101, encodeId=c3c1159810175, content=<a href='/topic/show?id=6c6f1e62c5' target=_blank style='color:#2F92EE;'>#ABO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, 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=Tue Jan 26 02:43:42 CST 2021, time=2021-01-26, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=919449, 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    2021-01-24 ms1000001433472600

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  10. 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    2021-01-24 ms1000001433472600

    1

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FDA批准默克的PD-L1单抗联合阿西替尼,用于治疗晚期肾细胞癌

美国食品和药物管理局(FDA)已批准Merck的PD-L1单抗Bavencio(avelumab)联合Inlyta(阿西替尼),用于晚期肾细胞癌RCC患者的一线治疗。

PD-1单抗Keytruda又一重大突破:与阿西替尼联合获欧盟批准用作晚期肾细胞癌(RCC)的一线治疗

此次批准基于第3阶段KEYNOTE-426试验,该试验表明,与辉瑞公司销售的老药 - 舒尼替尼相比,Keytruda联合治疗使死亡风险降低了47%。

NEJM:派姆单抗联合阿西替尼与舒尼替尼治疗晚期肾细胞癌疗效比较

由此可见,在先前未治疗的晚期肾细胞癌患者中,与舒尼替尼治疗相比,用派姆单抗加阿西替尼治疗导致总生存期和无进展生存期显著延长,以及更高的客观缓解率。

IKCS 2020:基于LENVIMA(lenvatinib)的联合疗法治疗肾细胞癌

日本卫材制药将在2020年11月6日至7日举行的2020年国际肾脏癌(IKCS)专题研讨会上展示七个摘要。

AACR 2020:基因治疗肾细胞癌获突破,DCR可达75%!

溶瘤病毒用于肿瘤治疗被寄予厚望,作为下一代的基因疗法的主要手段。虽然它还有很多缺点,如瘤内给药的操作不够便捷、易产生中和抗体无法实现系统给药、单药使用应答率不高。而且第一个溶瘤病毒T-vec的获批上市

拓展阅读

43个月长期随访结果:帕博利珠单抗加阿昔替尼一线治疗晚期肾细胞癌

该研究旨在评估帕博利珠单抗加阿昔替尼与舒尼替尼一线治疗晚期肾细胞癌的43个月长期随访结果,研究结果进一步支持帕博利珠单抗加阿昔替尼作为该群体的标准护理。

三联疗法可延缓晚期肾细胞癌进展!NEJM:可使疾病进展或死亡风险降低了27%!

这是第一项针对免疫肿瘤学双重对照评估三联疗法的研究,初步结果清晰地展示了这种三联疗法的疗效和安全性。

J Immunother Cancer:Bempegaldesleukin联合纳武单抗一线治疗晚期肾细胞癌

BEMPEG联合纳武单抗在晚期肾透明细胞癌患者中作为一线治疗显示出了初步的抗肿瘤活性,而且耐受性良好

J Clin Oncol:ICI联合VEGFR抑制剂治疗晚期肾细胞癌时的主要不良心血管事件风险

接受ICI和VEGFR抑制剂联合治疗的肌钙蛋白 T 水平较高的患者需要更密切地监测心血管不良事件。

J Clin Oncol:卡博替尼与阿特珠单抗的联合方案在晚期肾细胞癌中初露锋芒!

在晚期 ccRCC 和 nccRCC 患者中,卡博替尼与阿特珠单抗的新型联合方案显示出了令人鼓舞的临床活性和可接受的耐受性

Clin Cancer Res:卡瑞珠单抗+法米替尼在晚期肾癌中表现出有效且持久的抗肿瘤活性

卡瑞珠单抗联合法米替尼在晚期或转移性肾细胞癌患者中展现出有效且持久的抗肿瘤活性