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肺癌一线免疫治疗!BMS明星免疫组合Opdivo+Yervoy获美国FDA批准第5个适应症,治疗转移性非小细胞肺癌患者!

2020-05-18 MedSci MedSci

Opdivo+Yervoy(OY组合)是美国FDA批准的第一个也是唯一一个双重免疫疗法。

百时美施贵宝近日宣布,美国食品药品监督管理局(FDA)已批准欧狄沃(纳武利尤单抗,3 mg / kg)联合伊匹木单抗(1 mg / kg,静脉注射)用于一线治疗转移性非小细胞肺癌(NSCLC)成人患者。患者需接受FDA批准的测试,确定其肿瘤表达PD-L1阳性(≥1%),且无EGFR 或ALK基因突变。
 
此项批准是基于III期临床研究CheckMate -2271a的数据。结果显示,最少随访时间29.3个月时,无论患者肿瘤组织学类型如何,欧狄沃联合伊匹木单抗(n=396)相比化疗(n=397)显著改善了患者的总生存期(OS)(hazard ratio [HR] 0.79; 95% confidence interval [CI]: 0.67 to 0.94; P=0.0066)。欧狄沃联合伊匹木单抗治疗组患者的中位OS为17.1个月 (95% CI: 15.0 to 20.1),化疗组为14.9个月 (95% CI: 12.7 to 16.7)。在这项试验中,欧狄沃联合伊匹木单抗组和化疗组患者的1年生存率分别为63%和56%,2年生存率分别是40%和33%,3年生存率(中位随访期:43.1个月)分别是33%和22%。
 
根据独立评审委员会(BICR)的评估结果,最少随访时间28.3个月时,欧狄沃联合伊匹木单抗治疗组患者的客观缓解率(ORR)为36% (142/396, 95% CI: 31 to 41,其中 5.8%为完全缓解[CR],30.1%为部分缓解[PR]),化疗组患者的ORR为30%(119/397, 95% CI: 26 to 35,1.8%为 CR,28.2%为 PR)。在出现缓解的患者中,欧狄沃联合伊匹木单抗组患者的持续缓解时间(DOR)为23.2个月 (95% CI: 15.2 to 32.2),化疗组为6.2个月 (95% CI: 5.6 to 7.4)。ORR和DOR均为预先指定的描述性分析。
 
CheckMate -227临床试验研究员、纪念斯隆·凯特琳癌症中心肿瘤内科医师Matthew D. Hellmann表示:“转移性肺癌患者仍需要有望带来持久获益的新的治疗选择。CheckMate -227试验结果表明,双免疫治疗能为符合指征的转移性非小细胞肺癌患者带来长期生存的机会。


使用欧狄沃应遵循以下警告与注意事项,包括免疫介导不良事件:肺炎、结肠炎、肝炎、内分泌疾病、肾炎和肾功能不全、皮肤不良反应、脑炎及其他不良反应;输液相关反应;胚胎-胎儿毒性;当欧狄沃与沙利度胺类似物和地塞米松联用时,会增加多发性骨髓瘤患者的死亡率,因此不建议在对照临床试验之外使用。请参阅下方的“重要安全性信息”章节,其中包括针对伊匹木单抗相关免疫介导不良反应的黑框警告。
 
GO2基金会联合创始人兼主席Bonnie J. Addario表示:“转移性肺癌是一种复杂而具有挑战性的疾病。转移性非小细胞肺癌患者一直在密切关注免疫治疗领域的进展,渴望获得能够显著延长生存期的全新治疗选择。如今,部分初治患者已经能够直接接受替代化疗的免疫联合治疗,并在超过三年的随访期中持续展示出生存获益,这代表着我们在治疗这种疾病的道路上又迈出了重要一步。”
 
欧狄沃联合伊匹木单抗是两种免疫检查点抑制剂的独特组合,具有潜在的协同作用机制,针对两个不同的检查点(PD-1和CTLA-4)以帮助消灭肿瘤细胞:伊匹木单抗帮助激活和增殖T细胞,而欧狄沃有助于现有的T细胞发现肿瘤。伊匹木单抗激活的某些T细胞可以分化为记忆T细胞,从而有望实现长期的免疫反应。但免疫疗法也有可能会针对正常细胞,从而导致免疫介导的不良反应,这种反应可能会很严重,甚至可能致命。请参阅“重要安全性信息”章节,其中包括针对伊匹木单抗相关免疫介导不良反应的黑框警告。
 
百时美施贵宝首席商业官Chris Boerner表示:“2015年,欧狄沃成为首个治疗非小细胞肺癌的免疫治疗,改变了非小细胞肺癌的治疗方式,从而开启了一个全新的时代。在此基础上,欧狄沃联合伊匹木单抗获批成为了首个一线双免疫疗法,成为了我们帮助转移性肺癌患者延长生存的又一里程碑。”
 
*Matthew D. Hellmann博士为百时美施贵宝提供有偿咨询和顾问服务。
 
注:伊匹木单抗尚未在中国大陆上市

关于CheckMate-227研究

CheckMate -227是一项随机、开放性、多中心III期临床试验,评估欧狄沃®联合伊匹木单抗对比含铂双药化疗用于初治转移性或复发性非小细胞肺癌(NSCLC)患者(包括鳞癌和非鳞癌)治疗的情况。试验的1a部分入组的是肿瘤表达PD-L1阳性(≥1%)的患者。

研究者在中心实验室使用PD-L1 IHC 28-8 pharmDx分析仪对肿瘤标本进行前瞻性评估。关键性入组标准为18岁及以上、IV期或复发性NSCLC、ECOG评分为0/1且未曾接受过系统性抗癌治疗的患者。本研究排除了存在对已知靶向抑制剂治疗敏感的EGFR突变或ALK易位、未治脑转移瘤、癌性脑膜炎、活动性自身免疫性疾病或需要采用系统性免疫抑制疗法的患者。

396例患者接受了欧狄沃(3 mg / kg,每两周一次)联合伊匹木单抗(1 mg / kg,每六周一次)治疗,397例患者接受了含铂双药化疗(每三周一次)。在随机进入化疗组的患者中,非鳞癌患者接受培美曲塞与顺铂(或卡铂)治疗,随后可选择接受培美曲塞维持治疗;鳞癌患者接受吉西他滨与顺铂(或卡铂)治疗。 患者持续接受治疗,直至出现疾病进展、不可接受的毒性或治疗时间达到24个月。 主要疗效终点指标是OS,其他描述性疗效结局指标包括BICR评估的无进展生存期、ORR和DOR。
 
CheckMate-227研究的部分安全性数据

58%的患者发生了严重不良反应。24%的患者因不良反应中止了欧狄沃联合伊匹木单抗治疗,53%的患者因某个不良反应至少停用其中一种药物。最常见的严重不良反应(≥2%) 包括感染性肺炎、腹泻/结肠炎、肺炎、肝炎、肺栓塞、肾上腺功能不全和垂体炎等。致命性不良反应的发生率为1.7%,包括肺炎(4例)、心肌炎、急性肾损伤、休克、高血糖、多系统器官衰竭和肾衰竭等。最常见的不良反应(≥20%)包括疲劳(44%)、皮疹(34%),食欲下降(31%)、肌肉骨骼疼痛(27%)、腹泻/结肠炎(26%)、呼吸困难(26%)、咳嗽(23%)、肝炎(21%)、恶心(21%)和瘙痒(21%)。

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createdName=1249842em09(暂无昵称), createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472011, encodeId=f2d414e20115c, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=)]
    2021-03-09 bugit
  4. 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createdName=1249842em09(暂无昵称), createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472011, encodeId=f2d414e20115c, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=)]
    2020-07-31 ms4394944258402050

    真好

    0

  5. 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    2020-05-20 119337457
  6. 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  7. [GetPortalCommentsPageByObjectIdResponse(id=1990720, encodeId=01b51990e20b1, content=<a href='/topic/show?id=5739822223f' target=_blank style='color:#2F92EE;'>#肺癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82222, encryptionId=5739822223f, topicName=肺癌患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f612331, createdName=gds2009, createdTime=Sat Oct 03 05:21:04 CST 2020, time=2020-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059900, encodeId=2ec0205990006, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, 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    2020-05-20 gostraight
  8. 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createdName=1249842em09(暂无昵称), createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472011, encodeId=f2d414e20115c, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=)]
    2020-05-20 canlab
  9. 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  10. [GetPortalCommentsPageByObjectIdResponse(id=1990720, encodeId=01b51990e20b1, content=<a href='/topic/show?id=5739822223f' target=_blank style='color:#2F92EE;'>#肺癌患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=82222, encryptionId=5739822223f, topicName=肺癌患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=f612331, createdName=gds2009, createdTime=Sat Oct 03 05:21:04 CST 2020, time=2020-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059900, encodeId=2ec0205990006, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=52, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, createdName=lingaifan, createdTime=Sat Nov 28 03:21:04 CST 2020, time=2020-11-28, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1839816, encodeId=284d18398161b, 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=56, 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=Tue Mar 09 10:21:04 CST 2021, time=2021-03-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=805360, encodeId=3118805360d9, content=真好, beContent=null, objectType=article, channel=null, level=null, likeNumber=110, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://thirdwx.qlogo.cn/mmopen/vi_32/DYAIOgq83erQrkOIzfwBga6HkhIYRgxV5WImc20Kn0UDj5V3dCatCL63PCiccB0Zqq4o8PiaAqZ0UpoFU2pg4BOQ/132, createdBy=01bd5120377, createdName=ms4394944258402050, createdTime=Fri Jul 31 11:15:45 CST 2020, time=2020-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1303098, encodeId=a545130309860, content=<a href='/topic/show?id=4264134043c' target=_blank style='color:#2F92EE;'>#Opdivo#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=90, 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 May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1336815, encodeId=437c1336815d7, content=<a href='/topic/show?id=554d94e13ae' target=_blank style='color:#2F92EE;'>#适应症#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=94713, encryptionId=554d94e13ae, topicName=适应症)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3dd32500118, createdName=644982816_68283321, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1365820, encodeId=28ba136582077, content=<a href='/topic/show?id=5b751895214' target=_blank style='color:#2F92EE;'>#Yervoy#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=83, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=18952, encryptionId=5b751895214, topicName=Yervoy)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=db5b227, createdName=gostraight, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378677, encodeId=a50113e867739, content=<a href='/topic/show?id=f238358866' target=_blank style='color:#2F92EE;'>#BMS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=115, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=3588, encryptionId=f238358866, topicName=BMS)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=512d422, createdName=canlab, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386624, encodeId=f009138662416, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, 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=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1472011, encodeId=f2d414e20115c, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=93, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Wed May 20 04:21:04 CST 2020, time=2020-05-20, status=1, ipAttribution=)]
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