CFDA批准上市口服多激酶抑制剂——Stivarga®(瑞戈非尼)审评概述,用于转移性结直肠癌患者

2017-11-28 新浪医药 新浪医药

瑞戈非尼/Regorafenib(商品名:Stivarga),是拜耳公司研发的一种口服多激酶抑制剂,作用于血管生成 (VEGFR1-3、TIE2),基质 (PDGFR-b、FGFR),肿瘤形成 (KIT、PDGFR和RET)和肿瘤免疫反应 (CSF1R )多个靶点,片剂,规格为40mg。本次在我国批准适用于治疗既往接受过以氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗, 以及既往接受过或不适合接受抗VE


瑞戈非尼/Regorafenib(商品名:Stivarga),是拜耳公司研发的一种口服多激酶抑制剂,作用于血管生成 (VEGFR1-3、TIE2),基质 (PDGFR-b、FGFR),肿瘤形成 (KIT、PDGFR和RET)和肿瘤免疫反应 (CSF1R )多个靶点,片剂,规格为40mg。本次在我国批准适用于治疗既往接受过以氟尿嘧啶、奥沙利铂和伊立替康为基础的化疗, 以及既往接受过或不适合接受抗VEGF治疗、 抗EGFR治疗(RAS野生型)的转移性结直肠癌(mCRC)患者。推荐剂量为160mg/天,于每一疗程的前21天口服,28天为一疗程。

支持该产品在我国批准用于晚期CRC患者的主要临床数据来自一项全球国际多中心Ⅲ期研究14384和在亚洲区域性的、采用相似的设计开展的一项国际多中心研究15808,以及一项在中国患者进行的药代动力学研究。

研究14384是在全球开展的一项支持该产品在国外上市的关键III期研究,采用随机、对照、双盲设计,瑞戈非尼加最佳支持治疗(BSC)对比安慰剂加BSC在标准治疗后疾病进展的转移性结直肠癌(mCRC)患者中疗效和安全性。共入组760例患者,主要终点为总生存期(OS),与安慰剂相比,瑞戈非尼治疗可显着延长转移性结直肠癌患者的总生存期(p=0.005178),具有统计学意义和临床意义。瑞戈非尼组患者的中位总生存期时间为196天(95% CI:178, 222 天),安慰剂组患者的中位总生存期时间为151天(95% CI:134, 177 天)。总生存期和无进展生存期的亚组分析也观察到瑞戈非尼组比安慰剂组具有更好的趋势(包括KRAS突变状态和FOIB/E前期治疗分析)。

研究15808是在亚洲区域开展的一项比瑞戈非尼加最佳支持治疗(BSC)对比安慰剂加BSC在标准治疗后疾病进展的转移性结直肠癌(mCRC)患者的随机、对照、开放、多中心的III期临床研究,共入组204例,其中172例为中国患者。与安慰剂相比,瑞戈非尼可明显延长OS(p=0.000159)。估算的HR为0.550(95% CI:0.395–0.765),死亡风险降低了45.0%。与OS的结果相一致,被随机分至瑞戈非尼组的患者的PFS明显长于BSC组(p<0.000001)。估算的HR为0.311(95% CI:0.222,0.435),与安慰剂相比风险降低了69.9%。该研究与全球Ⅲ期研究14387结果相似。172例中国亚组分析结果也与总体人群结果相似。

研究14996为在中国晚期难治性实体瘤患者中开展的评价的单次和多次(第21天)口服给药的药代动力学、安全性、耐受性研究,结果表明,中国患者服用160mg瑞戈非尼的PK特征与高加索人I期研究(11650)的结果具有可比性。

安全性方面,接受瑞戈非尼治疗的患者中最常见的不良反应包括手足皮肤反应(53.5%;安慰剂8%)、腹泻(41%;安慰剂14%)、食欲下降(38%;安慰剂23.8%)和疲劳(36.5%;安慰剂25.8%)。瑞戈非尼组中已报告且发生率比安慰剂组高于10个百分点的不良事件为食欲下降、腹泻、言语障碍、疲劳、高血压、粘膜炎症、手足皮脸反应、发热、皮疹、口腔炎和体重下降。在研究15808中观察到的不良反应特征与全球关键性研究14387及14874的结果也是一致的,未发现新的安全性信号。

此次还同时批准了本品用于“既往接受过甲磺酸伊马替尼及苹果酸舒尼替尼治疗的局部晚期的、无法手术切除的或转移性的胃肠道间质瘤(GIST)患者”。支持该产品在我国批准的主要临床数据来自一项全球国际多中心Ⅲ期研究14874,是在全球开展的一项支持该产品在国外上市的关键Ⅲ期研究,采用随机、对照、双盲设计,瑞戈非尼加最佳支持治疗(BSC)对比安慰剂加最佳支持治疗在既往接受过伊马替尼和舒尼替尼治疗的进展期转移性和/或无法手术的胃肠道间质瘤(GIST)受试者的Ⅲ期临床研究。共入组199例患者(入组中国患者11 例,因样本量有限,未再做单独分析),主要终点为无进展生存期(PFS),与安慰剂加最佳支持治疗组相比,瑞戈非尼加最佳支持治疗组可显着延长转移性结直肠癌患者的PFS(p<0.000001),具有统计学意义和临床意义。瑞戈非尼组患者和安慰剂患者的中位PFS分别为147天 和 28 天,疾病进展或死亡的相对风险降低约73.2%(HR 0.268, 95% CI:0.185,0.388)。

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    2018-02-13 jklm09
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    2017-12-31 bugit
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  4. 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  5. 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href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1453029, encodeId=a9d6145302925, content=<a href='/topic/show?id=098ee8679ad' target=_blank style='color:#2F92EE;'>#结直肠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78679, encryptionId=098ee8679ad, topicName=结直肠)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=9ace5575596, createdName=crystal0564, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1495990, encodeId=72b014959905d, content=<a href='/topic/show?id=9c516685eea' target=_blank style='color:#2F92EE;'>#激酶#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66857, encryptionId=9c516685eea, topicName=激酶)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=73449239400, createdName=redcrab, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=)]
    2018-10-12 stfoxst
  6. 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href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1453029, encodeId=a9d6145302925, content=<a href='/topic/show?id=098ee8679ad' target=_blank style='color:#2F92EE;'>#结直肠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78679, encryptionId=098ee8679ad, topicName=结直肠)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=9ace5575596, createdName=crystal0564, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1495990, encodeId=72b014959905d, content=<a href='/topic/show?id=9c516685eea' target=_blank style='color:#2F92EE;'>#激酶#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66857, encryptionId=9c516685eea, topicName=激酶)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=73449239400, createdName=redcrab, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=)]
    2017-12-05 虈亣靌

    讲解的非常好,值得学习

    0

  7. 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href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1453029, encodeId=a9d6145302925, content=<a href='/topic/show?id=098ee8679ad' target=_blank style='color:#2F92EE;'>#结直肠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78679, encryptionId=098ee8679ad, topicName=结直肠)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=9ace5575596, createdName=crystal0564, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1495990, encodeId=72b014959905d, content=<a href='/topic/show?id=9c516685eea' target=_blank style='color:#2F92EE;'>#激酶#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66857, encryptionId=9c516685eea, topicName=激酶)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=73449239400, createdName=redcrab, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=)]
    2017-12-01 虈亣靌

    学习了提高了

    0

  8. 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  9. 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  10. 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topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Tue Dec 05 12:45:09 CST 2017, time=2017-12-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=265926, encodeId=6d902659269f, content=学习了提高了, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/mONcle9pic3zMoyicyo6ia9f4IuLQAwZoxD6Hx4ibd5CMcOCYhStY6oDibbKK6O2X8iaicldO5ib8j1iapOIobIKCGiczU2A/0, createdBy=56251941490, createdName=虈亣靌, createdTime=Fri Dec 01 10:51:25 CST 2017, time=2017-12-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386317, encodeId=c0e7138631ed2, content=<a 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00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1495990, encodeId=72b014959905d, content=<a href='/topic/show?id=9c516685eea' target=_blank style='color:#2F92EE;'>#激酶#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=32, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66857, encryptionId=9c516685eea, topicName=激酶)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=73449239400, createdName=redcrab, createdTime=Thu Nov 30 00:56:00 CST 2017, time=2017-11-30, status=1, ipAttribution=)]
    2017-11-30 redcrab

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