CheckMate-870结果公布: 欧狄沃240毫克固定剂量30分钟输注在以中国人群为主的经治晚期或转移性NSCLC患者中安全可靠

2020-06-30 MedSci MedSci

百时美施贵宝(纽约证券交易所代码:BMY)近日在美国癌症研究协会在线年会(AACR 2020)上公布了CheckMate-870的研究结果。

百时美施贵宝(纽约证券交易所代码:BMY)近日在美国癌症研究协会在线年会(AACR 2020)上公布了CheckMate-870的研究结果。CheckMate-870是一项开放标签的IIIB期临床研究,旨在评估经治晚期或转移性非小细胞肺癌患者在接受欧狄沃单药治疗后的安全性和有效性。研究采用240毫克固定剂量,30分钟静脉输注(每两周一次)的方式,直至患者出现疾病进展或不可耐受情况,最长治疗时间24个月。结果显示,在非HBV感染患者中,最常见的3-4级治疗相关选择性不良反应主要为肝脏(2.3%),皮肤(1.6%),肺(1.0%)及内分泌(0.8%),5级治疗相关选择性不良反应发生率为0%。在HBV感染患者中,3-5级治疗相关选择性不良反应发生率为0%。在所有患者中,3-4级治疗相关不良反应总发生率为12.8%,由3-4级治疗相关不良反应导致的停药率为2.0%。研究表明,欧狄沃在治疗人群中的安全性特征与既往基于体重剂量(3mg/kg),60分钟输注的关键性研究一致,未发现新的安全性信号。


在CheckMate-870的意向治疗人群中,研究者依据EGFR突变、HBV感染情况、组织学类型以及PD-L1表达情况对患者进行了亚组分析。结果显示,中位随访时间9.6个月时,所有治疗患者的6个月总生存率为75% (95% CI: 70–79%),客观缓解率(ORR)为15.5%;HBV感染患者与非HBV感染患者ORR分别为17.6%和15.4%,EGFR基因突变患者与非突变患者的ORR分别为14.7%和14.2%。证实了欧狄沃在HBV感染及EGFR突变人群中具有抗肿瘤活性。

CheckMate-870的首要研究者、上海交通大学附属胸科医院肿瘤科主任陆舜教授表示:”作为第一个在中国获批上市的肿瘤免疫治疗药物,欧狄沃的安全性已在国内外的临床实践中得到广泛证实。此次研究进一步证实了固定剂量30分钟输注的方案在以中国患者为主的经治晚期或转移性非小细胞肺癌患者中同样安全,包括EGFR突变和HBV感染的患者在内。这为提高临床使用的便利性和应用于特殊人群提供了新的证据,更多晚期非小细胞肺癌患者将获益于欧狄沃的治疗。”

百时美施贵宝中国大陆及香港医学事务负责人严桥表示:“肺癌是中国,乃至全球最为高发的疾病之一,晚期非小细胞肺癌患者存在巨大的未被满足的治疗需求。CheckMate-870研究为欧狄沃在中国人群中的使用剂量以及在特殊人群中的应用提供了新的科学认知。未来,我们将继续探索肿瘤免疫治疗对于不同患者群体的潜在益处,通过提供全线治疗方案为更广泛的患者带来更具创新性和便利性的治疗选择,帮助患者战胜严重疾病。”
 
关于CheckMate-870研究

CheckMate-870是一项开放标签的IIIB期临床研究,旨在评估以中国患者为主的经治晚期或转移性非小细胞肺癌(包括鳞癌和非鳞癌)患者在接受欧狄沃单药治疗后的安全性和有效性。研究共入组400例亚裔患者,其中394例为中国患者。所有患者均接受欧狄沃240 毫克,30分钟,每两周一次的静脉输注,直至疾病进展或发生不可耐受毒性,最长治疗时间24个月。

研究纳入了17例乙肝病毒(HBV)感染患者(HBV DNA<500 IU/ml); 以及部分EGFR基因突变(34例)和ALK基因融合(10例)的患者,患者既往均接受过包括靶向治疗及化疗在内的两项系统治疗。

主要研究终点为非HBV感染患者的高级别(3-5级)治疗相关选择性不良反应的发生率。次要研究终点包括:HBV感染患者高级别(3-5级)治疗相关选择性不良反应发生率,所有患者的安全性,以及包括OS(总生存期)、ORR(客观缓解率)、PFS(无进展生存期)等在不同组织学类型、PD-L1表达状态以及HBV感染和EGFR突变状态下的有效性。研究同时对药物经济学、乙肝感染患者的HBV DNA改变、患者报告结局、生物标志物等进行了探索性分析。

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    2020-09-22 jklm09
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    2020-06-30 mswert122

    精细化研究

    0

  9. [GetPortalCommentsPageByObjectIdResponse(id=1723664, encodeId=85871e23664fb, content=<a href='/topic/show?id=02ef93401bb' target=_blank style='color:#2F92EE;'>#转移性NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=35, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93401, encryptionId=02ef93401bb, topicName=转移性NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=230533519197, createdName=changhe724, createdTime=Fri Mar 05 10:55:59 CST 2021, time=2021-03-05, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2004422, encodeId=c59e200442209, content=<a href='/topic/show?id=54ebe8621cf' target=_blank style='color:#2F92EE;'>#结果公布#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=78621, encryptionId=54ebe8621cf, topicName=结果公布)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=279b407, createdName=shanyongle, createdTime=Sat Jul 18 22:55:59 CST 2020, time=2020-07-18, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2068994, encodeId=e4f1206899405, content=<a href='/topic/show?id=bbd816043f2' target=_blank style='color:#2F92EE;'>#SCLC患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16043, encryptionId=bbd816043f2, topicName=SCLC患者)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=44a360, createdName=jklm09, createdTime=Tue Sep 22 15:55:59 CST 2020, time=2020-09-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2025223, encodeId=529b20252230b, content=<a href='/topic/show?id=eeeb459812' target=_blank style='color:#2F92EE;'>#Checkmate#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=26, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4598, encryptionId=eeeb459812, topicName=Checkmate)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=365d170, createdName=chenwq08, createdTime=Mon Nov 16 15:55:59 CST 2020, time=2020-11-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1376938, encodeId=d9ce13e6938af, content=<a href='/topic/show?id=4df06311110' target=_blank style='color:#2F92EE;'>#欧狄沃#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=63111, encryptionId=4df06311110, topicName=欧狄沃)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=62a7397, createdName=charl1234567, createdTime=Thu Jul 02 08:55:59 CST 2020, time=2020-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386640, encodeId=0a21138664012, 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=31, 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 Jul 02 08:55:59 CST 2020, time=2020-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410850, encodeId=e80d141085014, content=<a href='/topic/show?id=a4ed130e7d0' target=_blank style='color:#2F92EE;'>#NSCLC患者#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13077, encryptionId=a4ed130e7d0, topicName=NSCLC患者)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=06332789533, createdName=xiongliangxl, createdTime=Thu Jul 02 08:55:59 CST 2020, time=2020-07-02, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=800635, encodeId=9bfb80063525, content=精细化研究, beContent=null, objectType=article, channel=null, level=null, likeNumber=56, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2017/02/28/889a1910ded7780f3c049b354f1648b7.jpg, createdBy=2a791737770, createdName=mswert122, createdTime=Tue Jun 30 21:41:18 CST 2020, time=2020-06-30, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039775, encodeId=a0e91039e7504, content=NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Tue Jun 30 20:55:59 CST 2020, time=2020-06-30, status=1, ipAttribution=)]
    2020-06-30 肿肿

    NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了

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