Lancet oncol:ALT-803(IL-15强激动剂)联合nivolumab用于转移性非小细胞肺癌安全性可耐受

2018-04-06 MedSci MedSci原创

利用PD-1或PD-L1阻滞的免疫疗法用于未选择的非小细胞肺癌(NSCLC)时,高达80%的患者无反应,而且,其中好多患者在治疗初期会对治疗产生抗药性。靶向IL-2和IL-15Rβγ共享通路的药物可诱导某些癌症获得完全缓解和持久性反应,但尚无研究对这些药物与抗PD-1免疫疗法联合治疗的安全性或疗效进行评估。现John M Wrangle等人对该药物联合疗法用于NSCLC患者的安全性、耐受性和活性进

利用PD-1或PD-L1阻滞的免疫疗法用于未选择的非小细胞肺癌NSCLC)时,高达80%的患者无反应,而且,其中好多患者在治疗初期会对治疗产生抗药性。靶向IL-2和IL-15Rβγ共享通路的药物可诱导某些癌症获得完全缓解和持久性反应,但尚无研究对这些药物与抗PD-1免疫疗法联合治疗的安全性或疗效进行评估。现John M Wrangle等人对该药物联合疗法用于NSCLC患者的安全性、耐受性和活性进行评估。

研究人员进行一非随机的开放性Ib期试验,从USA的三家医院招募年满18岁的既往治疗过的组织学或细胞学确诊的IIIB或IV期NSCLC患者。予以抗PR-1单克隆抗体nivolumab 静脉 3mg/kg(后改为240mg)14天一疗程(作为新疗法或病程进展期的维持治疗)和IL-15强激动剂ALT-803 皮下用药 1/周(1-5周)6周一疗程,共4个疗程持续6个月。ALT-803的剂量浓度:6、10、15或20ug/kg。主要评估指标:安全性和耐受性,并确定与nivolumab结合的情况下,推荐用于2期试验的ALT-803的剂量。

2016年1月18日-2017年6月28日,共招募23位患者,其中21位接受4个剂量水平的ALT-803联合nivolumab治疗。两位患者分别因注册期间发生白细胞减少和肺功能障碍未接受治疗。无剂量限制性毒性,最大耐受剂量未达到。最常见的副反应是注射点反应(19/21[90%])和流感样症状(15[71%])。两位患者均出现两种3级副反应:淋巴细胞减少和疲劳。一位患者发生3级心肌梗塞。无4/5级副反应。推荐用于2期的ALT-803剂量是20ug/kg 1/周 皮下注射,联合nivolumab 240mg 静脉 1/2周。

ALT-803联合nivolumab用于门诊患者安全性可接受。采用PD-1单克隆抗体治疗的复发性或难治性疾病患者,补充ALT-803治疗后的临床活性,提示ALT-803联合nivolumab或许可成为NSCLC患者的新的可有效抗肿瘤的治疗方案。

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    2018-10-03 snf701207
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    2018-07-30 wetgdt
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encryptionId=1b6210686b2, topicName=Lancet)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=3f0227, createdName=howi, createdTime=Sat Aug 25 12:40:00 CST 2018, time=2018-08-25, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1865404, encodeId=895f1865404df, content=<a href='/topic/show?id=16ce133504e' target=_blank style='color:#2F92EE;'>#Oncol#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=34, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=13350, encryptionId=16ce133504e, topicName=Oncol)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=b63894, createdName=minlingfeng, createdTime=Sun Apr 22 03:40:00 CST 2018, time=2018-04-22, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2007894, encodeId=501b200e894ca, content=<a href='/topic/show?id=601512826f6' target=_blank style='color:#2F92EE;'>#NIV#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Aug 12 12:40:00 CST 2018, time=2018-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861208, encodeId=c07a186120834, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, encryptionId=401a23e102, topicName=ALT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Mon Nov 19 07:40:00 CST 2018, time=2018-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386378, encodeId=509113863e842, content=<a 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time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508210, encodeId=fc121508210da, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9624, encryptionId=8d4596248e, topicName=IL-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f6cf9946833, createdName=jjjiang0202, createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=)]
    2018-08-25 howi
  5. [GetPortalCommentsPageByObjectIdResponse(id=1911961, encodeId=4acb191196119, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Oct 03 06:40:00 CST 2018, time=2018-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059694, encodeId=888d2059694be, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, 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level=null, likeNumber=29, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=12826, encryptionId=601512826f6, topicName=NIV)], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=674961, createdName=tamgche, createdTime=Sun Aug 12 12:40:00 CST 2018, time=2018-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1861208, encodeId=c07a186120834, content=<a href='/topic/show?id=401a23e102' target=_blank style='color:#2F92EE;'>#ALT#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=22, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=2371, encryptionId=401a23e102, topicName=ALT)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ccbd84, createdName=shizhenshan, createdTime=Mon Nov 19 07:40:00 CST 2018, time=2018-11-19, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386378, encodeId=509113863e842, content=<a href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1471998, encodeId=8abe14e1998e0, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508210, encodeId=fc121508210da, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9624, encryptionId=8d4596248e, topicName=IL-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f6cf9946833, createdName=jjjiang0202, createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=)]
    2018-04-22 minlingfeng
  6. [GetPortalCommentsPageByObjectIdResponse(id=1911961, encodeId=4acb191196119, content=<a href='/topic/show?id=4de7112046c' target=_blank style='color:#2F92EE;'>#mAb#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=11204, encryptionId=4de7112046c, topicName=mAb)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=25e7304, createdName=snf701207, createdTime=Wed Oct 03 06:40:00 CST 2018, time=2018-10-03, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2059694, encodeId=888d2059694be, content=<a href='/topic/show?id=2cc599381bd' target=_blank style='color:#2F92EE;'>#非小细胞#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=30, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=99381, encryptionId=2cc599381bd, topicName=非小细胞)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=2e07307, 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href='/topic/show?id=f08293399f9' target=_blank style='color:#2F92EE;'>#转移性#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93399, encryptionId=f08293399f9, topicName=转移性)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=1ac22500003, createdName=1249842em09(暂无昵称), createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1471998, encodeId=8abe14e1998e0, content=<a href='/topic/show?id=c4d79344044' target=_blank style='color:#2F92EE;'>#转移性非小细胞肺癌#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=24, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93440, encryptionId=c4d79344044, topicName=转移性非小细胞肺癌)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=14b77195705, createdName=anan, createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508210, encodeId=fc121508210da, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9624, encryptionId=8d4596248e, topicName=IL-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f6cf9946833, createdName=jjjiang0202, createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=)]
    2018-08-12 tamgche
  7. 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time=2018-04-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1508210, encodeId=fc121508210da, content=<a href='/topic/show?id=8d4596248e' target=_blank style='color:#2F92EE;'>#IL-1#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=23, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9624, encryptionId=8d4596248e, topicName=IL-1)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f6cf9946833, createdName=jjjiang0202, createdTime=Sun Apr 08 01:40:00 CST 2018, time=2018-04-08, status=1, ipAttribution=)]
    2018-11-19 shizhenshan
  8. 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    2018-04-08 jjjiang0202

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