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JCO:Pembrolizumab治疗难治性,微卫星不稳定性高/错配修复缺陷的转移性结直肠癌的II期开放标签研究:KEYNOTE-164

2019-11-19 海北 MedSci原创

临床试验KEYNOTE-164(NCT02460198)评估了派姆单抗在已接受治疗的,转移性微卫星不稳定性高/错配修复缺陷型(MSI-H / dMMR)大肠癌(CRC)中的抗肿瘤活性。

临床试验KEYNOTE-164NCT02460198)评估了派姆单抗在已接受治疗的,转移性微卫星不稳定性高/错配修复缺陷型(MSI-H / dMMR)大肠癌(CRC)中的抗肿瘤活性。

这项II期开放标签研究涉及全球128个中心。符合条件的患者年龄≥18岁,患有转移性MSI-H / dMMR CRC,并接受过≥2种标准治疗,包括氟嘧啶,奥沙利铂和伊立替康(队列A),或有≥1个既往治疗线(队列B)。 

MSI-H / dMMR状态在本地进行了评估。患者每3周接受200 mg pembrolizumab 的治疗,长达2年,直至病情恶化,毒性不可接受或停药。主要终点是根据RECIST 1.1版通过独立的中央评估得出的客观回应率。次要终点是反应持续时间,无进展生存期(PFS),总生存期,安全性和耐受性。

该研究总共招募了124MSI-H / dMMR CRC患者(A61例,B63例)。数据截止时,队列A的中位随访时间为31.3个月(范围0.2-35.6个月),队列B的中位随访时间为24.2个月(范围0.1-27.1个月)。客观缓解率为33%(95CI21%至46%)和33%(95CI22%至46%),两组均未达到中位反应持续时间。 

PFS中位数为2.3个月(95CI2.18.1个月)和4.1个月(95CI2.118.9个月)。中位总体生存期为31.4个月(95CI,未达到21.4个月)和未达到(95CI,未达到19.2个月)。

与治疗相关的3-4级不良反应发生在队列A中的10名患者(16%)和队列B中的8名患者(13%)中,其中最常见的发生在≥2名患者中的不良反应包括胰腺炎,疲劳,丙氨酸转氨酶增加,和队列A中的脂肪酶增加。

因此,该临床试验线束,派姆单抗对MSI-H / dMMR CRC患者有效,安全性可控。


原始出处:

Le DT et al. Phase II Open-Label Study of Pembrolizumab in Treatment-Refractory, Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: KEYNOTE-164. PNAS, 2019; DOI: 10.1200/JCO.19.02107. 


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    2020-06-29 lidong40
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    2020-06-06 snf701207
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createdBy=6da1120, createdName=lidong40, createdTime=Mon Jun 29 04:38:00 CST 2020, time=2020-06-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1912250, encodeId=16541912250d0, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Sat Jun 06 08:38:00 CST 2020, time=2020-06-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1728201, encodeId=873e1e282013b, content=<a href='/topic/show?id=986913980dd' target=_blank style='color:#2F92EE;'>#PE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=77, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13980, encryptionId=986913980dd, topicName=PE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f06c33759375, createdName=feather89, createdTime=Sun May 31 14:38:00 CST 2020, time=2020-05-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1645533, encodeId=5af716455332c, content=<a href='/topic/show?id=20c296e40e2' target=_blank style='color:#2F92EE;'>#错配修复缺陷#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=94, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=96740, encryptionId=20c296e40e2, topicName=错配修复缺陷)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a68823222118, createdName=李研东, createdTime=Fri Jan 17 23:38:00 CST 2020, time=2020-01-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2078505, encodeId=989120e85054b, content=<a href='/topic/show?id=9cf9505582e' target=_blank style='color:#2F92EE;'>#微卫星#</a>, beContent=null, objectType=article, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272541, encodeId=46c212e254134, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Thu Nov 21 06:38:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2020-05-31 feather89
  5. [GetPortalCommentsPageByObjectIdResponse(id=1703438, encodeId=79861e034384e, content=<a href='/topic/show?id=2fdf10464e6' target=_blank style='color:#2F92EE;'>#KEYNOTE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10464, encryptionId=2fdf10464e6, topicName=KEYNOTE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94e330506057, createdName=tm10051991, createdTime=Thu Oct 08 01:38:00 CST 2020, time=2020-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1891608, encodeId=f56f189160876, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272541, encodeId=46c212e254134, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Thu Nov 21 06:38:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
  6. [GetPortalCommentsPageByObjectIdResponse(id=1703438, encodeId=79861e034384e, content=<a href='/topic/show?id=2fdf10464e6' target=_blank style='color:#2F92EE;'>#KEYNOTE#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=109, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10464, encryptionId=2fdf10464e6, topicName=KEYNOTE)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=94e330506057, createdName=tm10051991, createdTime=Thu Oct 08 01:38:00 CST 2020, time=2020-10-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1891608, encodeId=f56f189160876, content=<a href='/topic/show?id=25b0102e2df' target=_blank style='color:#2F92EE;'>#JCO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=78, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10272, encryptionId=25b0102e2df, topicName=JCO)], attachment=null, authenticateStatus=null, createdAvatar=, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272541, encodeId=46c212e254134, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Thu Nov 21 06:38:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2020-04-11 qjddjq
  7. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1272541, encodeId=46c212e254134, content=<a href='/topic/show?id=4323140286a' target=_blank style='color:#2F92EE;'>#Pembrolizumab#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=66, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14028, encryptionId=4323140286a, topicName=Pembrolizumab)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ac59108, createdName=hxj0117, createdTime=Thu Nov 21 06:38:00 CST 2019, time=2019-11-21, status=1, ipAttribution=)]
    2020-10-16 chendoc242
  8. 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Brit J Cancer:派姆单抗对晚期粘膜黑色素瘤患者的抗肿瘤活性

由此可见,无论先前有无接受伊匹木单抗治疗,派姆单抗都能为晚期粘膜黑色素瘤患者提供持久的抗肿瘤活性。

NEJM:派姆单抗联合化疗对鳞状非小细胞肺癌的疗效分析

由此可见,在先前未治疗的转移性鳞状NS​​CLC患者中,用卡铂加紫杉醇或nab-紫杉醇对化疗中加入派姆单抗导致总生存期和无进展生存期明显长于单独化疗。

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