双免疫联合治疗肺癌添新证,百时美施贵宝宣布CheckMate-227 1a达到总生存期的共同主要终点

2019-07-25 MedSci MedSci

王伯今年68岁,一年前反复右膝关节肿痛,血尿酸水平比正常值稍高一点,测过的最高值为463μmol/L,先后在两家医院诊断为痛风,曾服用过非布司他片,2周后发现血尿酸已恢复至正常值。

2019年7月24日,百时美施贵宝(纽约证券交易所代码:BMY)公布了III期临床研究CheckMate-227 1a达到了总生存期(OS)的共同主要终点,即与化疗相比,欧狄沃与低剂量伊匹木单抗联合治疗用于PD-L1≥1%的一线非小细胞肺癌(NSCLC)患者,能够带来显著的生存获益。


CheckMate 227 1a达到终点

CheckMate 227是一项开放性III期临床研究,评估以欧狄沃®为基础的治疗方案对比含铂双药化疗用于晚期非小细胞肺癌(NSCLC)患者(包括鳞癌和非鳞癌患者)一线治疗的情况。该研究共分为下列部分:

• 第1部分:

1a部分:在PD-L1表达的患者中,评估与化疗相比,欧狄沃联合低剂量ipilimumab以及欧狄沃单药治疗的疗效

1b部分:在未表达PD-L1的患者中,评估与化疗相比,欧狄沃联合低剂量ipilimumab,以及欧狄沃联合化疗的疗效

研究第1部分在评估欧狄沃联合伊匹木单抗(与化疗比较)时共有两个主要终点:一个是具有PD-L1表达的肿瘤患者的总生存期(OS, 在1a部分评估),另一个主要终点是高肿瘤突变负荷(TMB > 10个突变/Mb,无论PD-L1表达状况如何)患者的无进展生存期(PFS,在1a和1b部分评估)。在第1部分中,在不考虑PD-L1表达状况的情况下,与化疗相比,将欧狄沃与伊匹木单抗联合用于高肿瘤突变负荷(TMB≥10个突变/Mb)患者,试验结果达到PFS共同主要终点。此外,相比化疗,欧狄沃与低剂量伊匹木单抗联合治疗用于PD-L1 ≥1%的一线非小细胞肺癌患者,可以带来更高的总生存期获益。

另外,与此前欧狄沃(3 mg/kg每2周)与低剂量伊匹木单抗(1 mg/kg,每6周)一线联用治疗非小细胞肺癌(NSCLC)患者的研究结果相比,本研究的安全性数据与先前保持一致。针对1b部分中未表达PD-L1患者的探索性分析显示,欧狄沃与低剂量伊匹木单抗联合疗法同样能为患者带来生存获益。公司期待在即将举行的医学会议上公布CheckMate 227研究第1部分的完整结果。

同时,百时美施贵宝还宣布,CheckMate 227研究的第2部分未达到预先设定的总生存期(OS)的主要研究终点。针对非鳞非小细胞肺癌患者,与化疗相比,欧狄沃与化疗联合治疗的研究结果未达到总生存期的主要终点。

百时美施贵宝肿瘤开发负责人、医学博士Fouad Namouni表示:“CheckMate 227是首个证实两种免疫肿瘤治疗(I-O)药物联合用于肺癌治疗的总生存期获益优于化疗的III期临床研究。肺癌成为了欧狄沃与伊匹木单抗联合疗法在随机III期临床研究中展示出显著总生存期获益的第三种肿瘤类型,这也进一步突出了伊匹木单抗在癌症治疗领域的重要性。我们诚挚地感谢参与这项试验的患者与研究人员。”

来自德国Grosshansdorf肺部研究中心的CheckMate 227研究者Martin Reck说:“在CheckMate 227临床研究1a部分中,欧狄沃与伊匹木单抗联合治疗的研究结果有望为一线肺癌患者带来‘无须化疗’的治疗方案,并证实能为患者带来优于化疗的总生存期获益。我同样很高兴地看到,无论PD-L1表达与否,患者均能从中获益。我期待在未来看到研究的全部数据。”

CheckMate临床研究与患者人群

CheckMate 037-治疗经治黑色素瘤;CheckMate 066-治疗初治黑色素瘤;CheckMate 067-单药或与YERVOY®(ipilimumab,伊匹木单抗)联用治疗初治黑色素瘤;CheckMate 017-二线治疗转移性鳞状非小细胞肺癌(NSCLC);CheckMate 057-二线治疗非鳞状NSCLC;CheckMate 032-治疗小细胞肺癌;CheckMate 025-治疗经治肾细胞癌 ;CheckMate214-与YERVOY联用治疗初治肾细胞癌;

CheckMate-205/039-治疗经典霍奇金淋巴瘤;CheckMate 141-治疗复发或转移性头颈部鳞状细胞癌;CheckMate 275-治疗尿路上皮癌; CheckMate142-单药或与YERVOY®(ipilimumab,伊匹木单抗)联用治疗高度微卫星不稳定(MSI-H)/ 错配修复缺陷(dMMR)转移性结直肠癌;CheckMate040-治疗原发性肝癌;CheckMate 238-黑色素瘤辅助治疗。

关于欧狄沃(纳武利尤单抗注射液)

欧狄沃是一种PD-1免疫检查点抑制剂,独特地利用人体自身的免疫系统来帮助机体恢复抗肿瘤免疫反应。这种通过利用人体自身免疫系统来抗击癌症的特性,使欧狄沃已成为多种肿瘤类型的重要治疗选择。

基于百时美施贵宝在I-O治疗领域的科学专长,欧狄沃拥有全球领先的研发项目,涵盖多种肿瘤类型的各期临床试验,包括III期临床试验。截至目前,欧狄沃的临床研发项目已有超过35,000名患者入组。欧狄沃的临床试验有助于加深理解生物标志物对患者治疗选择的潜在提示作用,特别是识别不同PD-L1表达水平的患者如何能够从欧狄沃中获益。

2014年7月,欧狄沃成为全球首个获得监管机构批准的PD-1免疫检查点抑制剂,目前欧狄沃已在超过65个地区获得批准,包括美国、欧盟、日本和中国。2015年10月,欧狄沃与伊匹木单抗联合治疗黑色素瘤成为首个获得监管机构批准的免疫肿瘤(I-O)药物联合疗法,目前已在超过60个地区获得批准,包括美国和欧盟。

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    2019-10-10 jktdtl
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  3. [GetPortalCommentsPageByObjectIdResponse(id=1685284, encodeId=9c471685284bb, content=<a href='/topic/show?id=03135881224' target=_blank style='color:#2F92EE;'>#施贵宝#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58812, encryptionId=03135881224, topicName=施贵宝)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=394828104279, createdName=jktdtl, createdTime=Thu Oct 10 06:24:00 CST 2019, time=2019-10-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1764459, encodeId=11ff1e644591a, content=<a href='/topic/show?id=8fe0e188265' target=_blank style='color:#2F92EE;'>#百时美#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71882, encryptionId=8fe0e188265, topicName=百时美)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c9b037737594, createdName=ms1467340776200723, createdTime=Mon Feb 24 18:24:00 CST 2020, time=2020-02-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2025214, encodeId=16ab2025214fe, content=<a href='/topic/show?id=eeeb459812' target=_blank style='color:#2F92EE;'>#Checkmate#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=4598, encryptionId=eeeb459812, topicName=Checkmate)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=365d170, createdName=chenwq08, createdTime=Sat Dec 14 09:24:00 CST 2019, time=2019-12-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1996950, encodeId=307e1996950bb, content=<a href='/topic/show?id=b706232e831' target=_blank style='color:#2F92EE;'>#主要终点#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=23278, encryptionId=b706232e831, topicName=主要终点)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7387164, createdName=zhangj7108, createdTime=Sat Mar 14 04:24:00 CST 2020, time=2020-03-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1313749, encodeId=91a31313e49d0, content=<a href='/topic/show?id=d4cc80e128f' target=_blank style='color:#2F92EE;'>#联合治疗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=18, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=80712, encryptionId=d4cc80e128f, topicName=联合治疗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=263b421, createdName=zhaozuguo, createdTime=Sat Jul 27 11:24:00 CST 2019, time=2019-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1353486, encodeId=650213534865e, content=<a href='/topic/show?id=43abe1883b6' target=_blank style='color:#2F92EE;'>#百时美施贵宝#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=71883, encryptionId=43abe1883b6, topicName=百时美施贵宝)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=4c37265, createdName=zhaojie88, createdTime=Sat Jul 27 11:24:00 CST 2019, time=2019-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1378220, encodeId=39c213e822064, content=<a href='/topic/show?id=c29b69004f9' target=_blank style='color:#2F92EE;'>#生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69004, encryptionId=c29b69004f9, topicName=生存期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat Jul 27 11:24:00 CST 2019, time=2019-07-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1516018, encodeId=b8051516018b4, content=<a href='/topic/show?id=bd0152e64f1' target=_blank style='color:#2F92EE;'>#总生存期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=27, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=52764, encryptionId=bd0152e64f1, topicName=总生存期)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=bdf610907545, createdName=12498cb5m16暂无昵称, createdTime=Sat Jul 27 11:24:00 CST 2019, time=2019-07-27, status=1, ipAttribution=)]
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