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Lancet oncol:Margetuximab联合派姆单抗治疗HER2+的胃食管腺癌

2020-07-14 QQY MedSci原创

Margetuximab是一种新型的尚在研究阶段的FC工程抗HER2单克隆抗体,在设计上该药拟比曲妥珠单抗能更有效,在临床上,其疗效是否如其设计的一样呢?让我们来看看其治疗胃食管癌的这一项临床试验。

Margetuximab是一种新型的尚在研究阶段的FC工程抗HER2单克隆抗体,在设计上该药拟比曲妥珠单抗能更有效地增强先天免疫力。本研究旨在评估margetuximab联合派姆单抗(抗PD-1单克隆抗体)用于既往治疗过的HER2阳性的胃食管腺癌的安全性、耐受性和抗肿瘤活性。

本研究是一项在多个国家多个中小开展的单臂、开放的1b-2期的剂量递增和队列扩展研究,招募年满18岁的组织学确诊的不可切除的局部晚期或转移性HER2阳性的PD-L1未选择的胃食管腺癌,ECOG表现评分0或1分,且要求既往至少有一次经曲妥珠单抗联合化疗(在局部晚期不可切除或转移情况下)治疗后病程进展。在剂量递增阶段,有9位患者接受治疗:3位接受margetuximab 10mg/kg(静滴)+ 派姆单抗 200mg(静滴),1/3周;6位患者接受推荐的2期剂量,即margetuximab 15 mg/kg + 派姆单抗 200mg(静滴),1/3周。另外在2期扩展队列中招募了86位患者,接受推荐的2期剂量治疗。主要终点是安全性和耐受性,以及客观缓解率。

2016年2月11日-2018年10月2日,共招募了95位患者。中位随访了19.9个月(IQR 10.7-23.1)。联合方案显示出可接受的安全性和耐受性;在剂量递增阶段,未观察到剂量限制性毒性。最常见的3-4级治疗相关的不良反应有贫血(4例[4%])和输液相关反应(3[3%])。重度治疗相关不良反应见于9位(9%)患者。无治疗相关死亡。在92位可评估患者中,有17位获得客观缓解(18.48%,95% CI 11.15-27.93)。

本研究了FC优化的抗HER2药物(margetuximab)与抗PD-1检查点阻滞剂(派姆单抗)联合使用可协同抗肿瘤活性。

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    2020-09-30 gujh
  3. 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    2021-04-19 minlingfeng
  4. 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GetPortalCommentsPageByObjectIdResponse(id=1437560, encodeId=56bb143e56059, content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Thu Jul 16 13:57:25 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
  5. 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    2020-11-11 snf701207
  6. 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    2020-08-27 14818eb4m67暂无昵称

    学习了

    0

  7. 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objectType=article, channel=null, level=null, likeNumber=150, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/20201214/b3170121d995432ea306ae3a7809cc05/2cfb236f361b4d3c80ef8fdef4301832.jpg, createdBy=8ad35400531, createdName=ms 内分泌科张, createdTime=Mon Jul 20 01:58:07 CST 2020, time=2020-07-20, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1253450, encodeId=107c125345091, content=<a href='/topic/show?id=1c4e65265d5' target=_blank style='color:#2F92EE;'>#派姆单抗#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=65265, encryptionId=1c4e65265d5, topicName=派姆单抗)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ce5632, createdName=jianjun66, createdTime=Thu Jul 16 13:57:25 CST 2020, time=2020-07-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1437560, encodeId=56bb143e56059, content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Thu Jul 16 13:57:25 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
    2021-01-21 howi
  8. 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GetPortalCommentsPageByObjectIdResponse(id=1437560, encodeId=56bb143e56059, content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Thu Jul 16 13:57:25 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
    2020-07-20 ms 内分泌科张

    学习

    0

  9. 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  10. 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GetPortalCommentsPageByObjectIdResponse(id=1437560, encodeId=56bb143e56059, content=<a href='/topic/show?id=0e311010591a' target=_blank style='color:#2F92EE;'>#食管#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=79, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=101059, encryptionId=0e311010591a, topicName=食管)], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/aLGWoFXAyMbIu3qymFOyheQLjPSX3OUs5GmkyBlcCOwTPIeq3why9NGibxxUqYo6hcx8qZLHZFgNPnBK1yzWeOFpyg2OnWOt0/0, createdBy=fa4716, createdName=zhouqu_8, createdTime=Thu Jul 16 13:57:25 CST 2020, time=2020-07-16, status=1, ipAttribution=)]
    2020-07-16 zhouqu_8

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Lancet Oncol:派姆单抗联合疗法一线治疗HER2阳性转移性食管胃癌

派姆单抗、曲妥珠单抗联合化疗可有效延长HER2阳性转移性食管胃癌患者无进展生存期

Lancet oncol:派姆单抗治疗未治疗过的脑转移的非小细胞肺癌的疗效和安全性

Goldberg等人在非小细胞肺癌(NSCLC)或黑素瘤伴未治疗的脑转移患者中开展了pembrolizumab(派姆单抗)的2期试验,以确定PD-1阻滞在中枢神经系统(CNS)中的活性。

Lancet oncol:派姆单抗联合培美曲塞-铂类治疗非鳞状非小细胞肺癌的患者自评预后

在KEYNOTE-189研究中,派姆单抗(Pembrolizumab)联合培美曲塞(pemetrexed)-铂类可提高非鳞状非小细胞肺癌的总生存率和无进展生存率,较高一部分患者获得完全或部分缓解。现研究人员对该研究患者的病人报告的探索性预后(PROs)进行评估。在KEYNOTE-189研究是一项在16个国家的126个癌症中心开展的双盲的、随机的、安慰剂为对照的3期临床试验,招募年满18睡的组织学确

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