ESMO Asia:FLAURA研究:奥希替尼显著延长PFS及ORR

2017-11-19 佚名 肿瘤资讯

2017年11月,FLAURA研究继2017年ESMO会议之后,更新结果再次唱响在新加坡隆重举行的ESMO Asia会议。结果显示,针对初治的EGFR突变阳性、晚期NSCLC患者,奥希替尼在延长患者PFS和持续应答时间等方面显着优于标准EGFR-TKI,并在多个亚组分析中维持PFS优势。此外,奥希替尼与标准TKI(吉非替尼、厄洛替尼)的药物安全性相当。更新的数据表明了FLAURA研究交叉治疗的充分

2017年11月,FLAURA研究继2017年ESMO会议之后,更新结果再次唱响在新加坡隆重举行的ESMO Asia会议。结果显示,针对初治的EGFR突变阳性、晚期NSCLC患者,奥希替尼在延长患者PFS和持续应答时间等方面显着优于标准EGFR-TKI,并在多个亚组分析中维持PFS优势。此外,奥希替尼与标准TKI(吉非替尼、厄洛替尼)的药物安全性相当。更新的数据表明了FLAURA研究交叉治疗的充分性。129例接受标准TKI治疗、出现疾病进展的患者中,有55例(43%)患者改为接受免费的奥希替尼二线治疗,其中,48例(87%)为研究交叉至实验组(30例患者在研究报告截止日期之时仍在口服奥希替尼,仅有18例患者停止用药),另外7例(13%)患者虽然退出临床研究、但仍在继续接受奥希替尼治疗。值得临床医生注意的是,奥希替尼组和标准TKI治疗组各有56例(20%)、84例(31%)的患者未能接受完整的二线治疗,提示我们需要综合考虑不同靶向药物的治疗时机和用药顺序等问题,着重考虑是应该优先使用疗效最佳的药物、或是保留疗效最佳的药物作为疾病复发时的杀手锏。

研究背景:

基于多项III期临床试验,现有指南已明确提出,对于EGFR突变阳性的晚期非小细胞肺癌(NSCLC)患者,目前的一线标准治疗方案为一代、二代EGFR-TKI靶向药。但在接受EGFR-TKI治疗的过程中,超过50%的患者会出现EGFR T790M的耐药突变。

第三代的EGFR-TKI奥希替尼(Osimertinib)可以高选择性地抑制EGFR敏感突变和T790M突变所导致的耐药。目前已经获批用于EGFR-TKI耐药后、T790M突变阳性的晚期NSCLC患者。此外,既往的研究也证实奥希替尼具有显着的血脑屏障穿透作用,可用于合并脑转移的晚期NSCLC患者。根据临床前数据和前期临床试验结果,奥希替尼可以作为EGFR突变阳性的晚期NSCLC患者的一线治疗方案。

在奥希替尼的I期临床试验AURA研究中,初治的EGFR突变型晚期NSCLC患者接受80 mg(n = 30)或160 mg(n = 30)qd奥希替尼治疗。结果显示,入组患者的整体客观缓解率(ORR)达77%,中位无进展生存期(PFS)可达20.5个月;其中,口服80mg奥希替尼组的患者、中位PFS为22.1个月 (95% CI = 13.7 - 30.2),口服160mg奥希替尼组的患者、中位PFS为19.3个月 (95% CI = 13.7 – 26.0)。奥希替尼治疗期间,疾病进展后的血浆标本(n = 38)监测显示,入组患者未出现EGFR T790M耐药突变。

研究设计:

FLAURA研究设计详见图1。其入组标准为:(1)>=18岁;(2)PS评分0 – 1;(3)EGFR 19外显子缺失或21外显子L858R突变阳性的晚期NSCLC;(4)既往未接受系统性抗肿瘤治疗或EGFR-TKI靶向治疗;(5)如患者存在疾病稳定的CNS转移,可以入组。

研究共入组556例患者,经EGFR突变状态(19外显子缺失vs. 21外显子L858R突变)和种族(亚裔vs. 非亚裔人群)分层后、随机进入奥希替尼组(80mg,口服,qd)或标准EGFR-TKI治疗组(吉非替尼250mg或厄洛替尼150mg,口服,qd),两组分别纳入279例和277例患者。治疗期间,根据RECIST 1.1、每6周评估一次疾病状态,直至疾病进展。FLAURA研究的首要终点为PFS,次要研究终点包括客观缓解率(ORR)、疾病持续应答时间(DOR)、应答情况、OS、药物毒性等。


图1. FLAURA研究设计流程图

研究结果:

1. 入组患者基线资料:

奥希替尼组和标准TKI治疗组的基线特征较为均衡。其中,奥希替尼组有19例CNS转移阳性的患者,标准TKI治疗组有23例CNS转移阳性的患者;两组的EGFR突变类型分布相同,EGFR 19外显子缺失和L858R突变的患者均分别为63例、37例。


2. 首要研究终点——PFS:

入组556例患者中,出现342个事件数,数据成熟度为62%;其中,奥希替尼组为136个事件数(占49%),标准TKI治疗组206个事件数(74%)。两组的中位PFS分别为18.9个月 (95% CI = 15.2 - 21.4)、10.2个月 (95% CI = 9.6 - 11.1)(HR = 0.46,95% CI = 0.37 - 0.57)(p<0.0001)(详见下图)。


从研究亚组分析可以看到(详见下图),即使以不同年龄、性别、种族、吸烟状态、PS评分、是否存在CNS转移、EGFR突变类型、cDNA监测EGFR突变状态等因素分组,奥希替尼均显示了与标准TKI治疗相比、更佳有效延长PFS的优势。


其中,以是否存在CNS转移为分层的亚组分析显示(详见下图):CNS转移阳性的晚期NSCLC患者(n = 116)中,奥希替尼组的中位PFS为15.2个月 (95% CI = 12.1 - 24.4)、9.6个月 (95% CI = 7.0 - 12.4)(HR = 0.47,95% CI = 0.30 - 0.74)(p=0.0009);不存在CNS转移的晚期NSCLC患者(n = 440)中,奥希替尼组的中位PFS为19.1个月 (95% CI = 15.2 - 23.5)、10.9个月 (95% CI = 9.6 - 12.3)(HR = 0.46,95% CI = 0.36 - 0.59)(p<0.0001)。


3. 次要研究终点:

首先,客观缓解率方面(详见下图)。奥希替尼组和标准TKI治疗组的客观缓解率分别为80%(95% CI = 75 - 85)、76%(95% CI = 70 - 81)。奥希替尼组的CR、PR、SD分别为3%、77%、17%。两组的中位持续应答时间分别为7.2个月 (95% CI = 13.8 - 22.0)、8.5个月 (95% CI = 7.3 - 9.8)。


根据入组患者的疗效评估可知(详见下图),奥希替尼组的肿瘤缩小比例明显高于标准TKI组,且肿瘤增大的患者比例较少。


其次,总生存方面(详见下图)。556例入组患者中,共有141个死亡事件,数据成熟度为25%。其中,奥希替尼组有58例死亡患者(21%),标准TKI治疗组有83例死亡事件(30%)。两组的中位OS均未达到(HR = 0.63,95% CI = 0.45 - 0.88;p=0.0068)(备注:25%的数据成熟度要求达到p<0.0015才具有统计学差异,故FLAURA研究的OS曲线暂无统计学差异)。

研究进行过程中,标准TKI治疗组的患者如出现疾病进展且存在EGFR T790M突变阳性,可交叉至奥希替尼组。至数据截止日之时,奥希替尼组和标准TKI治疗组各有141例(51%)和64例 (23%)患者仍在其接受随机治疗组的治疗方案(详见下图)。经RECIST评估为疾病进展的患者中,两组各有82例(29%)和129例(47%)接受了后线的抗肿瘤治疗。129例接受标准TKI治疗的患者中,有55例(43%)患者改为接受免费的奥希替尼二线治疗,其中,48例(87%)为研究交叉至实验组(30例患者在研究报告截止日期之时仍在口服奥希替尼,仅有18例患者停止用药),另外7例(13%)患者虽然退出临床研究、但仍在继续接受奥希替尼治疗。由此可知,FLAURA研究的交叉治疗较为充分。

另外,由于临床上存在疾病死亡、药物相关毒副反应、身体耐受性降低等原因,较多患者未能有机会接受二线治疗。从下图的FLAURA研究总结数据中可以看到,奥希替尼组和标准TKI治疗组各有56例(20%)、84例(31%)的患者未能接受完整的二线治疗。而在未接受后线抗肿瘤治疗的患者中,两组的死亡例数分别为33例(12%)、46例(17%)。由此可知,临床医生在治疗开始时应该向患者及家属充分表明不同靶向药物的优势以及治疗时机、药物应用顺序等问题,着重考虑是应该优先使用疗效最佳的药物、或是保留疗效最佳的药物作为疾病复发时的杀手锏。

第三,药物安全性方面。

奥希替尼组、标准TKI治疗组出现3级及3级以上不良反应的例数分别为94例(34%)、124例(45%),潜在药物相关的不良反应分别为49例(18%)、78例(28%)。

两组的不良反应发生率整体较低。其中,奥希替尼组中最为常见的、3级及3级以上的不良反应依次为腹泻、食欲降低、QT间期延长等。对比两组的不良反应发生率可以看到,奥希替尼组中,痤疮样皮炎、AST升高、ALT升高均显着低于标准TKI治疗组。奥希替尼在保护肝功能、降低皮肤反应等方面具有较为显着的优势。

研究结论:

首先,与标准TKI(吉非替尼、厄洛替尼)相比,奥希替尼均能够显着延长EGFR突变阳性的NSCLC患者的PFS获益、降低54%的疾病进展风险(HR= 0.46,95% CI= 0.37 - 0.57; p<0.0001)、延长患者的持续缓解时间(中位 17.2 个月vs. 8.5 个月)。CNS转移阳性、阴性的亚组人群中,奥希替尼均显示了其延长PFS获益的优势。第二,中期OS分析虽然未达到中位生存数据,也可看到奥希替尼在延长OS获益的趋势HR= 0.63,95% CI= 0.45 - 0.88; p=0.0068)。

虽然奥希替尼组出现3级及3级以上不良反应的发生率及因药物毒性而终止治疗的发生率均低于标准治疗组,但总体而言,奥希替尼的药物安全性与标准TKI大致相当。

综上所述,奥希替尼可以作为EGFR突变阳性的晚期NSCLC患者的新型一线标准治疗方案。

现场专家点评

虽然对于EGFR突变阳性的晚期NSCLC患者,一代、二代TKI已然成为标准治疗方案。但是标准TKI治疗过程中出现T790M耐药突变的发生率可达50%,导致TKI治疗失败。

基于其前期临床研究数据,奥希替尼已经获批应用于EGFR-TKI治疗失败后T790M突变阳性的晚期NSCLC患者,并且奥希替尼治疗期间,疾病进展后的血浆标本(n = 38)监测显示,入组患者未出现EGFR T790M耐药突变。此外,CNS活性可延长脑转移患者的生存获益。此次公布的FLAURA研究结果显示,在初治的EGFR突变型晚期NSCLC患者中,奥希替尼可显着延长的亚组分析也证实了奥希替尼可显着延长患者的PFS获益(两组的中位PFS分别为18.9个月vs. 10.2个月,p<0.0001),并提高肿瘤客观缓解率(两组的ORR分别为80%、76%)及中位持续应答时间(两组DOR分别为7.2个月、8.5个月)。多项亚组分析中,奥希替尼组的PFS获益仍能持续,尤其是在脑转移阳性的患者中。虽然目前FLAURA研究的OS数据尚不成熟,但从OS曲线可以看出奥希替尼组倾向于有更多的OS获益。我们可以看到,基于奥希替尼的前期数据及FLAURA的疗效数据,对于初治的EGFR突变型晚期NSCLC患者,奥希替尼可以作为可选的一线标准治疗方案。

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    2018-06-27 liuhuangbo
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    2018-01-24 luwei00
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  4. [GetPortalCommentsPageByObjectIdResponse(id=2024803, encodeId=e19f20248032d, content=<a href='/topic/show?id=c27516459de' target=_blank style='color:#2F92EE;'>#SMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=16459, encryptionId=c27516459de, topicName=SMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6779163, createdName=liuhuangbo, createdTime=Wed Jun 27 14:41:00 CST 2018, time=2018-06-27, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1780085, encodeId=953f1e80085a4, content=<a href='/topic/show?id=10d62860dd' target=_blank style='color:#2F92EE;'>#ASIA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2860, encryptionId=10d62860dd, topicName=ASIA)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e093393, createdName=luwei00, createdTime=Wed Jan 24 07:41:00 CST 2018, time=2018-01-24, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2040493, encodeId=6fc3204049304, content=<a href='/topic/show?id=8289e49017' target=_blank style='color:#2F92EE;'>#FLAURA#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=41, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7490, encryptionId=8289e49017, topicName=FLAURA)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=e1cc90, createdName=rebeccajiejie, createdTime=Fri Jun 15 10:41:00 CST 2018, time=2018-06-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1940505, encodeId=5a3d194050569, content=<a href='/topic/show?id=a983e49197' target=_blank style='color:#2F92EE;'>#FLAURA研究#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7491, encryptionId=a983e49197, topicName=FLAURA研究)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c30265, createdName=jiafufeng@yaho, createdTime=Fri Jul 06 05:41:00 CST 2018, time=2018-07-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1280949, encodeId=ccac12809490c, content=<a href='/topic/show?id=50d6e0215a' target=_blank style='color:#2F92EE;'>#ESMO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=38, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=7021, encryptionId=50d6e0215a, topicName=ESMO)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7460166, createdName=zhang92560, createdTime=Tue Nov 21 12:41:00 CST 2017, time=2017-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1448648, encodeId=50df1448648a8, content=<a href='/topic/show?id=aaf21412e7e' target=_blank style='color:#2F92EE;'>#PFS#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14127, encryptionId=aaf21412e7e, topicName=PFS)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=47f75418389, createdName=jeanqiuqiu, createdTime=Tue Nov 21 12:41:00 CST 2017, time=2017-11-21, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1590687, encodeId=7269159068e84, content=<a href='/topic/show?id=e31d134e83e' target=_blank style='color:#2F92EE;'>#ORR#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13478, encryptionId=e31d134e83e, topicName=ORR)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8a7b17846501, createdName=psybestwish, createdTime=Tue Nov 21 12:41:00 CST 2017, time=2017-11-21, status=1, ipAttribution=)]
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    2017-11-21 zhang92560
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    2017-11-21 jeanqiuqiu
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    2017-11-21 psybestwish

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