研究5年随访结果更新,初治PD-L1≥50%的晚期NSCLC 5年生存率达29.6%

2019-06-12 佚名 肿瘤资讯

免疫治疗进展依旧是ASCO的焦点话题,本次ASCO KEYNOTE-001研究NSCLC队列的5年随访OS结果在本次会议上以LBA的形式公布,6月1日ASCO的Daily News就预告了这一重磅结果,6月2日下午的壁报讨论专场上,来自纪念斯隆凯瑟琳癌症中心的Kathryn Arbour教授对这一研究进行现场点评。目前,KEYNOTE-001研究5年随访结果已经在JCO 杂志同步在线发表,延长随访

免疫治疗进展依旧是ASCO的焦点话题,本次ASCO KEYNOTE-001研究NSCLC队列的5年随访OS结果在本次会议上以LBA的形式公布,6月1日ASCO的Daily News就预告了这一重磅结果,6月2日下午的壁报讨论专场上,来自纪念斯隆凯瑟琳癌症中心的Kathryn Arbour教授对这一研究进行现场点评。目前,KEYNOTE-001研究5年随访结果已经在JCO 杂志同步在线发表,延长随访的数据进一步证实,帕博利珠单抗用于初治或经治晚期NSCLC可以带来长期的生存获益,在PD-L1≥50%的晚期初治NSCLC 患者中,5年生存率更是达到29.6%。

KEYNOTE-001  5年随访OS结果更新

KEYNOTE-001研是一项多中心IB期临床研究,旨在评估帕博利珠单抗治疗晚期肿瘤的有效性和安全性,其中就包括非小细胞肺癌。本次ASCO更新了KEYNOTE-001研究NSCLC队列随访5年的OS结果,这是帕博利珠单抗治疗晚期NSCLC入组量最大、随访最长的疗效和安全性数据。NSCLC队列共入组患者550例,其中初治患者101例,经治(至少接受过一线治疗)患者449例。根据irRC研究者评估的患者治疗疗效。

总生存OS

截至2018年11月5日,患者的中位随访时间为60.6个月(51.8~77.9),82%(n=450/550)的患者已经死亡,仍有100例患者存活;60例患者接受了≥2年帕博利珠单抗治疗(初治患者n=14;经治患者n=46)。总体而言,所有患者的5年生存率至少为15%以上。

在初治患者中,仅入组了PD-L1 TPS≥1%的患者,结果显示,TPS≥50%和1~49%的患者,中位OS分别为35.4和19.5个月,5年OS率分别为29.6%和15.7%。

在经治患者中,同时入组了PD-L1 TPS<1%的患者,结果显示,TPS≥50%、1~49%和<1%的患者,中位OS分别为15.4、8.5和8.6个月,5年OS率分别为25.0%、12.6%和3.5%。

接受≥2年帕博利珠单抗治疗的患者结局

60例患者接受了≥2年帕博利珠单抗治疗,治疗的中位时长为36个月(范围17.3~75.9)。截至本次分析时,46例患者仍然存活。初治患者(n=14)和经治患者(n=46)的5年OS率分别为78.6%和75.8%;ORR分别为86%(12/14)和91%(42/46);中位疗效持续时间分别为52个月(范围10.2~55.7+)和NR(范围12.5~71.8+)。截至目前,初治和经治疗患者仍分别有7例(58%)和30例(71%)持续观察到疗效。

不良反应事件

截止数据分析时,患者的中位治疗时长为3.3个月(1天~75.9个月),治疗相关AE的发生率为71%(388/550),3~5级治疗相关AE的发生率为13%(69/550)。其中,免疫介导不良事件(irAE)发生率为17%(92/550),与3年随访数据相似。大多数irAE为1~2度,常见的irAE包括甲减、肺炎、甲亢、皮肤毒性等。

在PD-1单抗尚未问世之前,晚期NSCLC接受标准化疗患者的5年生存率约为5.5%(SEER数据库2008~2014年统计结果),帕博利珠单抗的问世,为晚期NSCLC带来有临床意义的5年OS改善。在PD-L1 TPS≥50%的患者中,帕博利珠单抗单药治疗的5年OS率至少为25%。在60例接受了2年或以上帕博利珠单抗治疗的患者中,超过85%的患者取得客观缓解,5年OS率超过75%。更长时间的安全性随访数据,并未观察到新的安全性事件,远期毒性,包括免疫相关毒性罕见发生。这一更新随访数据进一步证实了,帕博利珠单抗用于初治或经治晚期NSCLC,可以带来长期获益。

来自纪念斯隆凯瑟琳癌症中心的Kathryn Arbour教授对这一研究进行现场点评。目前KEYNOTE-001研究5年随访OS数据已经在JCO 杂志发布,回顾研究中的重要数据,我们发现,对于TPS≥50%的患者,初治和经治患者的5年OS率分别达到29.6%和25.0%,这是非常震撼人心的。随着患者接受帕博利珠单抗治疗时间的延长和生存期的延长,我们会更加关注药物的安全性和患者的不良反应事件。从研究结果来看,5年随访和3年随访的安全性对比,数据相似,没有需要特别关注的严重远期毒性,例如我们非常关注的肺炎和甲状腺炎的发生率,5年随访数据和3年相似。那么,我们是否可以根据这一结果推测所有接受PD-1单抗治疗的患者的5年生存率都能达到30%?目前尚不能。首先,KEYNOTE-001研究是一项I期研究;其次,PD-L1 TPS≥50%是一类高选择人群。回顾帕博利珠单抗的系列研究,我们可以看到,KEYNOTE-001研究中,患者的2年OS率为66.7%;在随机KEYNOTE-024研究中,患者的2年OS率为51.5%,两个研究数据是基本相似。

综上所述,KEYNOTE-001研究的5年随访数据进一步证实了PD-1单抗可以让患者取得长期、持久的疾病缓解。在PD-L1≥50%的初治和经治患者中,5年OS率分别达到29.6%和25%,且没有观察到新的远期毒性。期待后续在大型随访临床研究中,继续观察患者的5年生存数据。

KEYNOTE-001研究以往报道结果回顾

KEYNOTE-001研究是一项IB期研究,包括晚期NSCLC和黑色素瘤队列。晚期NSCLC队列的初步结果在2015年新英格兰医学杂志发表。研究初步评估了帕博利珠单抗治疗晚期NSCLC的疗效和安全性,同时尝试评估和验证PD-L1表达水平是否和帕博利珠单抗的疗效获益相关。主要研究终点为评估帕博利珠单抗的安全性、副作用和抗肿瘤活性。

在首次报道时,共495例患者接受帕博利珠单抗治疗(剂量水平为2mg/kg或10mg/kg,q3w;或10mg/kg,q2w)。中位随访时间位10.9个月,115例(23.2%)患者仍在持续接受治疗。患者随机分为训练集(182例)和验证集(313例)。结果显示,在总体人群中,帕博利珠单抗的ORR为 19.4%;其中394例经治患者和101例初治患者的ORR分别为18.0%和24.8%。最佳疗效为SD的患者为21.8%。帕博利珠单抗的ORR与用药剂量、疗程和组织学分析无相关性。截至本次分析,总体人群的中位DOR为12.5个月;其中经治患者和初治患者分别为10.4个月和23.3个月。总体人群的中位PFS为3.7个月,其中经治患者和初治患者分别为3.0个月和6.0个月。总体人群的中位OS为12个月。其中经治患者和初治患者分别为9.3个月和16.2个月。

生物标志物分析中,将182例分配至训练集将用于确定PD-L1 的cut-off值;最终确立将PD-L1 TPS≥50%作为cut-off值。验证集中的313例患者,经治和初治患者分别为223例和90例。在TPS≥50%的患者,帕博利珠单抗的ORR为45.2%,其中经治患者和初治患者分别为43.9%和50.0%。长期疗效数据显示,TPS≥50%的患者,中位PFS为6.3个月;其中经治患者和初治患者分别为6.1和12.5个月;中位OS尚未达到。

安全性分析显示,315例(70.9%)患者出现治疗相关的不良反应(AE)。帕博利珠单抗常见的副作用包括疲劳、瘙痒和食欲减低。3度或以上的AE发生率为9.5%(47/495)。治疗相关的、由炎症或免疫介导的、发生率>2%的AE包括输液相关反应(3%)、甲减(6.9%)和肺炎(3.6%)。

这一研究结果显示,帕博利珠单抗副作用可接受,并显示出一定的抗肿瘤疗效。PD-L1 TPS>=50%的患者,接受帕博利珠单抗治疗的疗效更优。后续的KEYNOTE-010研究进一步验证了这一研究结果,在PD-L1 TPS≥1%的患者中,帕博利珠单抗对比多西他赛用于经治晚期NSCLC,可以显着改善OS。

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  3. [GetPortalCommentsPageByObjectIdResponse(id=1914414, encodeId=56461914414c3, content=<a href='/topic/show?id=ecd31481c3' target=_blank style='color:#2F92EE;'>#5年随访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1481, encryptionId=ecd31481c3, topicName=5年随访)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76fa353, createdName=tm10051981, createdTime=Fri Mar 13 05:22:00 CST 2020, time=2020-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818796, encodeId=12a31818e9613, content=<a href='/topic/show?id=9687984e5e3' target=_blank style='color:#2F92EE;'>#随访结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98475, encryptionId=9687984e5e3, topicName=随访结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Thu Oct 17 12:22:00 CST 2019, time=2019-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1255005, encodeId=fc88125500555, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256714, encodeId=20d81256e1456, content=<a href='/topic/show?id=43706900963' target=_blank style='color:#2F92EE;'>#生存率#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69009, encryptionId=43706900963, topicName=生存率)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6a6043, createdName=guoyibin, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416300, encodeId=a3a9141630039, content=<a href='/topic/show?id=6cef59801ea' target=_blank style='color:#2F92EE;'>#晚期NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59801, encryptionId=6cef59801ea, topicName=晚期NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b093156350, createdName=经常头晕, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=367678, encodeId=f3e536e6786e, content=持续随访的结果, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Thu Jun 13 08:16:56 CST 2019, time=2019-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039680, encodeId=b1591039680af, 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=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jun 12 21:22:00 CST 2019, time=2019-06-12, status=1, ipAttribution=)]
    2019-06-14 smartjoy
  4. [GetPortalCommentsPageByObjectIdResponse(id=1914414, encodeId=56461914414c3, content=<a href='/topic/show?id=ecd31481c3' target=_blank style='color:#2F92EE;'>#5年随访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1481, encryptionId=ecd31481c3, topicName=5年随访)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76fa353, createdName=tm10051981, createdTime=Fri Mar 13 05:22:00 CST 2020, time=2020-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818796, encodeId=12a31818e9613, content=<a href='/topic/show?id=9687984e5e3' target=_blank style='color:#2F92EE;'>#随访结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98475, encryptionId=9687984e5e3, topicName=随访结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Thu Oct 17 12:22:00 CST 2019, time=2019-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1255005, encodeId=fc88125500555, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256714, encodeId=20d81256e1456, content=<a href='/topic/show?id=43706900963' target=_blank style='color:#2F92EE;'>#生存率#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69009, encryptionId=43706900963, topicName=生存率)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6a6043, createdName=guoyibin, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416300, encodeId=a3a9141630039, content=<a href='/topic/show?id=6cef59801ea' target=_blank style='color:#2F92EE;'>#晚期NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59801, encryptionId=6cef59801ea, topicName=晚期NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b093156350, createdName=经常头晕, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=367678, encodeId=f3e536e6786e, content=持续随访的结果, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Thu Jun 13 08:16:56 CST 2019, time=2019-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039680, encodeId=b1591039680af, 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=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jun 12 21:22:00 CST 2019, time=2019-06-12, status=1, ipAttribution=)]
  5. [GetPortalCommentsPageByObjectIdResponse(id=1914414, encodeId=56461914414c3, content=<a href='/topic/show?id=ecd31481c3' target=_blank style='color:#2F92EE;'>#5年随访#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=51, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=1481, encryptionId=ecd31481c3, topicName=5年随访)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=76fa353, createdName=tm10051981, createdTime=Fri Mar 13 05:22:00 CST 2020, time=2020-03-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1818796, encodeId=12a31818e9613, content=<a href='/topic/show?id=9687984e5e3' target=_blank style='color:#2F92EE;'>#随访结果#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=98475, encryptionId=9687984e5e3, topicName=随访结果)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c3ff68, createdName=维他命, createdTime=Thu Oct 17 12:22:00 CST 2019, time=2019-10-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1255005, encodeId=fc88125500555, content=<a href='/topic/show?id=be71139214f' target=_blank style='color:#2F92EE;'>#PD-L1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13921, encryptionId=be71139214f, topicName=PD-L1)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e76f39, createdName=smartjoy, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1256714, encodeId=20d81256e1456, content=<a href='/topic/show?id=43706900963' target=_blank style='color:#2F92EE;'>#生存率#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69009, encryptionId=43706900963, topicName=生存率)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=6a6043, createdName=guoyibin, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1416300, encodeId=a3a9141630039, content=<a href='/topic/show?id=6cef59801ea' target=_blank style='color:#2F92EE;'>#晚期NSCLC#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=28, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=59801, encryptionId=6cef59801ea, topicName=晚期NSCLC)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=3b093156350, createdName=经常头晕, createdTime=Fri Jun 14 09:22:00 CST 2019, time=2019-06-14, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=367678, encodeId=f3e536e6786e, content=持续随访的结果, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=c4a5105539, createdName=lovetcm, createdTime=Thu Jun 13 08:16:56 CST 2019, time=2019-06-13, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1039680, encodeId=b1591039680af, 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=34, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f0620, createdName=肿肿, createdTime=Wed Jun 12 21:22:00 CST 2019, time=2019-06-12, status=1, ipAttribution=)]
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    2019-06-13 lovetcm

    持续随访的结果

    0

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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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