阿帕替尼+卡瑞利珠单抗联合出击,为NSCLC患者带来新希望

2019-06-11 佚名 中国医学论坛报今日肿瘤

在刚刚结束的第55届美国临床肿瘤学会(ASCO?)年会上,一项由同济大学附属肺科医院周彩存教授作为主要研究者(PI),应用阿帕替尼联合免疫检查点抑制剂治疗晚期非小细胞肺癌(NSCLC)的临床研究结果在肺癌专场上公布。记者在第一时间采访了周彩存教授,请他向广大读者介绍该项研究的详细情况。患者的福音——晚期NSCLC一线治疗或进入无化疗时代

在刚刚结束的第55届美国临床肿瘤学会(ASCO?)年会上,一项由同济大学附属肺科医院周彩存教授作为主要研究者(PI),应用阿帕替尼联合免疫检查点抑制剂治疗晚期非小细胞肺癌NSCLC)的临床研究结果在肺癌专场上公布。记者在第一时间采访了周彩存教授,请他向广大读者介绍该项研究的详细情况。患者的福音——晚期NSCLC一线治疗或进入无化疗时代

周彩存主任医师、教授,同济大学附属上海市肺科医院肿瘤科主任,同济大学医学院肿瘤研究所所长,中国临床肿瘤学会(CSCO)非小细胞肺癌专委会主任委员

强大理论依据作支撑,助研究一步步迈向成功

血管生成治疗、基于驱动基因的靶向治疗及免疫治疗是本世纪肺癌治疗的重大进展。有研究显示,相较于单纯化疗,抗血管生成治疗联合多西他赛可显着提高一线化疗进展后NSCLC患者的无进展生存期(PFS)和总生存期(OS)。从作用机制来讲,阿帕替尼这类小分子酪氨酸激酶抑制剂(TKI)能够逆转多药耐药,增强化疗药物的抗肿瘤作用。在一代EGFR-TKI缓慢进展的晚期NSCLC患者中,阿帕替尼联合EGFR-TKI也获得了更长的PFS和更高的疾病控制率(DCR)。

肺癌免疫治疗也正在如火如荼地探索中,药物的联合使用逐渐成为肺癌治疗的全新格局。卡瑞利珠单抗(研发代号SHR-1210)是由我国恒瑞医药研发的人源化抗PD-1抗体。周彩存教授表示,其团队进行的动物模型研究表明,卡瑞利珠单抗联合低剂量阿帕替尼治疗NSCLC,可诱导肿瘤内异常血管正常化,重塑肿瘤免疫抑制性的微环境。该结果说明了二者联合可协同增效,为接下来的临床试验提供了依据。

在此背景下,周教授团队开展了一项多中心、开放标签的I期临床研究,探索卡瑞利珠单抗联合阿帕替尼治疗晚期EGFR和ALK野生型NSCLC患者的有效性和安全性。该I期研究探索了不同剂量阿帕替尼(250 mg/d、375 mg/d)联合卡瑞利珠单抗(200 mg,q2w)用于既往接受过二线及以上化疗的晚期非鳞NSCLC患者的有效性和安全性。研究结果表明,患者客观缓解率(ORR)达41.2%,DCR达94.1%。该临床数据进一步说明卡瑞利珠单抗联合阿帕替尼具有协同增效的效果。

因此,周教授团队启动了卡瑞利珠单抗联合阿帕替尼的多中心II期临床研究。具体研究方案为,阿帕替尼250 mg/d,卡瑞利珠单抗标准剂量200 mg q2w。研究发现,相较于单用卡瑞利珠单抗或阿帕替尼,二者联合治疗晚期NSCLC疗效显着,不同类型患者中位无进展生存期(PFS)可延长至6~7个月。在安全性方面,联合方案也表现出色,不仅不良事件发生较少,还可显着降低由卡瑞利珠单抗引起的反应性毛细血管增生症(15.6%)。上述临床研究结果入选此次ASCO大会,说明学界对该研究结果的认可。

从患者出发,向晚期NSCLC一线治疗无化疗时代前进

值得注意的是,在临床实践中,由于化疗产生的不良反应较严重,很多晚期NSCLC患者并不愿接受化疗。周教授指出,既往有数据显示,抗血管生成靶向联合免疫治疗中可为NSCLC患者带来更多获益。因此,III期临床研究计划将卡瑞利珠单抗联合阿帕替尼的治疗方案向一线推进,研究得到的结果极有可能改变约40%~50% NSCLC患者的一线治疗方案,使晚期NSCLC的一线治疗进入无化疗时代,为患者带来获益。

除此之外,周教授表示,其团队也正在进行卡瑞利珠单抗联合化疗在晚期肺腺癌中疗效的研究,以及卡瑞利珠单抗联合紫杉醇、卡铂治疗肺鳞癌的研究等,这些数据会陆续公布。

相关链接之研究简介

PD-1抑制剂卡瑞利珠单抗联合阿帕替尼治疗EGFR和ALK野生型的晚期非鳞NSCLC的临床研究(摘要号9112)

该研究根据I期研究结果,选择了阿帕替尼(250 mg/d)联合卡瑞利珠单抗的方案。纳入96例晚期非鳞NSCLC患者,其中23例接受过二线及以上的系统治疗,73例接受过一线治疗。主要研究终点为ORR。治疗前采集患者既往储存的或新鲜的肿瘤组织和血液标本,检测其PD-1表达和肿瘤突变负荷(TMB),并分析其与疗效的相关性。

结果显示,在91例可评估的患者中,总ORR为30.8%,中位PFS为5.9个月。在所有96例患者中,83例患者进行了bTMB检测,通过ROC曲线计算其临界值为1.54 muts/Mb。可评估的高bTMB患者ORR达52.6%。在数据收集截止时,有29例受试者仍在接受治疗。

常见的治疗相关性不良事件(TRAEs)包括高血压、手足综合征、γ-谷氨酰转移酶(GGT)升高、蛋白尿、肝功异常和碱性磷酸酶升高等。?安全性方面,观察到的AE主要与阿帕替尼相关,可以通过调整阿帕替尼给药频次进行管理

该研究结果提示,卡瑞利珠单抗联合阿帕替尼治疗非鳞NSCLC显示出良好的抗肿瘤效果,尤其是对于高bTMB的患者,且安全性可控。后续仍需前瞻性研究来进一步确认此临床结果以及bTMB作为疗效预测因子的有效性。

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    2020-12-20 lovetcm

    结果公布了,确实厉害

    0

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    2019-06-27 珙桐
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    2020-01-23 jklm09
  5. [GetPortalCommentsPageByObjectIdResponse(id=909652, encodeId=fa0f90965244, content=结果公布了,确实厉害, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sun Dec 20 22:04:54 CST 2020, time=2020-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=909651, encodeId=24129096511a, content=<a href='/topic/show?id=1f883652ea9' target=_blank style='color:#2F92EE;'>#卡瑞利珠单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=107, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36527, encryptionId=1f883652ea9, topicName=卡瑞利珠单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20220519/c2ab253484ee4527a2d4e9589a4821ac/45de9bf494a54becb2ea4369c9d11e85.jpg, createdBy=7a3710, createdName=lovetcm, createdTime=Sun Dec 20 22:04:36 CST 2020, time=2020-12-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1969993, encodeId=5f5219699936d, content=<a href='/topic/show?id=ec345834075' target=_blank style='color:#2F92EE;'>#新希望#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=39, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=58340, encryptionId=ec345834075, topicName=新希望)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25d7319, createdName=珙桐, createdTime=Thu Jun 27 23:08:00 CST 2019, time=2019-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2068979, encodeId=b18220689e95f, 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=37, 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=Thu Jan 23 08:08:00 CST 2020, time=2020-01-23, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1410836, encodeId=d88f141083618, 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=41, 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 Jun 13 12:08:00 CST 2019, time=2019-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1502857, encodeId=96c1150285ef8, content=<a href='/topic/show?id=d56636526e4' target=_blank style='color:#2F92EE;'>#卡瑞利珠#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=36526, encryptionId=d56636526e4, topicName=卡瑞利珠)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8d779566916, createdName=by2012, createdTime=Thu Jun 13 12:08:00 CST 2019, time=2019-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039673, encodeId=730a10396e382, 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=57, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jun 12 00:08:00 CST 2019, time=2019-06-12, status=1, ipAttribution=)]
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    2019-06-12 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

    0

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