J Immunother Cancer:瘤内溶瘤病毒V937加伊匹木单抗治疗 晚期黑色素瘤的疗效

2023-01-21 MedSci原创 MedSci原创 发表于上海

V937是一种生物选择的、无基因修饰的柯萨奇病毒A21,此前在晚期黑色素瘤患者中作为单药治疗以及与程序性细胞死亡1(PD-1)抗体帕博利珠单抗联合使用,已显示出抗肿瘤活性。

V937是一种生物选择的、无基因修饰的柯萨奇病毒A21,此前在晚期黑色素瘤患者中作为单药治疗以及与程序性细胞死亡1(PD-1)抗体帕博利珠单抗联合使用,已显示出抗肿瘤活性。

近日,发表于J Immunother Cancer的一项开放标签、单臂、1b期研究(NCT02307149)评估了V937加上细胞毒性T淋巴细胞抗原4抑制剂伊匹木单抗对晚期黑色素瘤患者的治疗效果。

研究纳入经组织学证实为转移性或不可切除的IIIB/C或IV期黑色素瘤的成年患者(年龄≥18岁),在第1、3、5、8和22天接受瘤内V937治疗,此后每3周(Q3W)一次,最多注射19组,同时从第22天开始静脉注射伊匹木单抗 3 mg/kg Q3W,共4次。在筛查时、第43天和106天以及此后每6周进行一次成像;根据研究者评估的免疫相关反应标准来评估治疗反应。主要终点是所有接受治疗的患者的安全性,以及所有接受治疗的患者和之前接受抗PD-1治疗后疾病进展的患者的客观缓解率(ORR)。

结果,共纳入50名患者接受治疗。在所有接受治疗的患者中,ORR为30%(95%CI为18%至45%),在之前未接受抗PD-1治疗的患者中,ORR为47%(95%CI为23%至72%),在之前接受抗PD-1治疗出现疾病进展的患者中,ORR为21%(95%CI为9%至39%)。注射和未注射的病灶都出现了肿瘤消退。免疫相关的中位生存期为6.2个月(95%CI为3.5至9.0个月),中位总生存期为45.1个月(95%CI为28.3个月至未达到)。最常见的治疗相关不良事件(AEs)是瘙痒(n=25,50%)、疲劳(n=22,44%)和腹泻(n=16,32%)。没有V937相关的剂量限制性毒性,也没有治疗相关的5级AEs。14%的患者出现了治疗相关的3级或4级AEs,所有的AEs都被认为与伊匹木单抗有关(最常见的是脱水、腹泻和肝脏毒性,各占4%)。

综上所述,该研究结果表明,与瘤内V937加伊匹木单抗相关的反应是强有力的,包括在先前抗PD-1治疗中出现疾病进展的患者亚组。药物相关的不良反应是可控的,并与个别单药的不良反应一致。

 

原始出处:

Brendan D Curti, etal., Intratumoral oncolytic virus V937 plus ipilimumab in patients with advanced melanoma: the phase 1b MITCI study. J Immunother Cancer. 2022 Dec;10(12):e005224. doi: 10.1136/jitc-2022-005224.

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  1. [GetPortalCommentsPageByObjectIdResponse(id=2142138, encodeId=14a82142138a1, content=<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a><a href='/topic/show?id=ef34e1239cd' target=_blank style='color:#2F92EE;'>#瘤内注射#</a>V937加<a href='/topic/show?id=7dbc25654c8' target=_blank style='color:#2F92EE;'>#伊匹木单抗#</a>相关的反应是强有力的,包括在先前抗PD-1治疗中出现疾病进展的患者亚组, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=71239, encryptionId=ef34e1239cd, topicName=瘤内注射), TopicDto(id=25654, encryptionId=7dbc25654c8, topicName=伊匹木单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sun Jun 11 01:22:12 CST 2023, time=2023-06-11, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111071, encodeId=f09d21110e1c1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/12/20/dafb36f63f4241903de36c3d053babb8.jpg, createdBy=d367105945, createdName=Midas, createdTime=Sat Jan 21 09:27:31 CST 2023, time=2023-01-21, status=1, ipAttribution=江苏省), GetPortalCommentsPageByObjectIdResponse(id=2111059, encodeId=50f6211105922, content=瘤内<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a>V937加<a href='/topic/show?id=597725653fd' target=_blank style='color:#2F92EE;'>#伊匹单抗#</a>治疗 晚期<a href='/topic/show?id=330410333110' target=_blank style='color:#2F92EE;'>#黑色素瘤#</a>的疗效,仍然从黑色素瘤入手,这是明智的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=25653, encryptionId=597725653fd, topicName=伊匹单抗), TopicDto(id=103331, encryptionId=330410333110, topicName=黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Sat Jan 21 09:12:29 CST 2023, time=2023-01-21, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111050, encodeId=714c211105092, content=不错,学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b08e8469269, createdName=ms4000000512201075, createdTime=Sat Jan 21 08:30:02 CST 2023, time=2023-01-21, status=1, ipAttribution=吉林省)]
    2023-06-11 侠胆医心 来自上海

    #溶瘤病毒##瘤内注射#V937加#伊匹木单抗#相关的反应是强有力的,包括在先前抗PD-1治疗中出现疾病进展的患者亚组

    0

  2. [GetPortalCommentsPageByObjectIdResponse(id=2142138, encodeId=14a82142138a1, content=<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a><a href='/topic/show?id=ef34e1239cd' target=_blank style='color:#2F92EE;'>#瘤内注射#</a>V937加<a href='/topic/show?id=7dbc25654c8' target=_blank style='color:#2F92EE;'>#伊匹木单抗#</a>相关的反应是强有力的,包括在先前抗PD-1治疗中出现疾病进展的患者亚组, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=71239, encryptionId=ef34e1239cd, topicName=瘤内注射), TopicDto(id=25654, encryptionId=7dbc25654c8, topicName=伊匹木单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sun Jun 11 01:22:12 CST 2023, time=2023-06-11, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111071, encodeId=f09d21110e1c1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/12/20/dafb36f63f4241903de36c3d053babb8.jpg, createdBy=d367105945, createdName=Midas, createdTime=Sat Jan 21 09:27:31 CST 2023, time=2023-01-21, status=1, ipAttribution=江苏省), GetPortalCommentsPageByObjectIdResponse(id=2111059, encodeId=50f6211105922, content=瘤内<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a>V937加<a href='/topic/show?id=597725653fd' target=_blank style='color:#2F92EE;'>#伊匹单抗#</a>治疗 晚期<a href='/topic/show?id=330410333110' target=_blank style='color:#2F92EE;'>#黑色素瘤#</a>的疗效,仍然从黑色素瘤入手,这是明智的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=25653, encryptionId=597725653fd, topicName=伊匹单抗), TopicDto(id=103331, encryptionId=330410333110, topicName=黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Sat Jan 21 09:12:29 CST 2023, time=2023-01-21, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111050, encodeId=714c211105092, content=不错,学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b08e8469269, createdName=ms4000000512201075, createdTime=Sat Jan 21 08:30:02 CST 2023, time=2023-01-21, status=1, ipAttribution=吉林省)]
    2023-01-21 Midas 来自江苏省

    学习了

    0

  3. [GetPortalCommentsPageByObjectIdResponse(id=2142138, encodeId=14a82142138a1, content=<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a><a href='/topic/show?id=ef34e1239cd' target=_blank style='color:#2F92EE;'>#瘤内注射#</a>V937加<a href='/topic/show?id=7dbc25654c8' target=_blank style='color:#2F92EE;'>#伊匹木单抗#</a>相关的反应是强有力的,包括在先前抗PD-1治疗中出现疾病进展的患者亚组, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=71239, encryptionId=ef34e1239cd, topicName=瘤内注射), TopicDto(id=25654, encryptionId=7dbc25654c8, topicName=伊匹木单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sun Jun 11 01:22:12 CST 2023, time=2023-06-11, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111071, encodeId=f09d21110e1c1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/12/20/dafb36f63f4241903de36c3d053babb8.jpg, createdBy=d367105945, createdName=Midas, createdTime=Sat Jan 21 09:27:31 CST 2023, time=2023-01-21, status=1, ipAttribution=江苏省), GetPortalCommentsPageByObjectIdResponse(id=2111059, encodeId=50f6211105922, content=瘤内<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a>V937加<a href='/topic/show?id=597725653fd' target=_blank style='color:#2F92EE;'>#伊匹单抗#</a>治疗 晚期<a href='/topic/show?id=330410333110' target=_blank style='color:#2F92EE;'>#黑色素瘤#</a>的疗效,仍然从黑色素瘤入手,这是明智的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=25653, encryptionId=597725653fd, topicName=伊匹单抗), TopicDto(id=103331, encryptionId=330410333110, topicName=黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Sat Jan 21 09:12:29 CST 2023, time=2023-01-21, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111050, encodeId=714c211105092, content=不错,学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b08e8469269, createdName=ms4000000512201075, createdTime=Sat Jan 21 08:30:02 CST 2023, time=2023-01-21, status=1, ipAttribution=吉林省)]
    2023-01-21 showtest 来自上海

    瘤内#溶瘤病毒#V937加#伊匹单抗#治疗 晚期#黑色素瘤#的疗效,仍然从黑色素瘤入手,这是明智的。

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=2142138, encodeId=14a82142138a1, content=<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a><a href='/topic/show?id=ef34e1239cd' target=_blank style='color:#2F92EE;'>#瘤内注射#</a>V937加<a href='/topic/show?id=7dbc25654c8' target=_blank style='color:#2F92EE;'>#伊匹木单抗#</a>相关的反应是强有力的,包括在先前抗PD-1治疗中出现疾病进展的患者亚组, beContent=null, objectType=article, channel=null, level=null, likeNumber=59, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=71239, encryptionId=ef34e1239cd, topicName=瘤内注射), TopicDto(id=25654, encryptionId=7dbc25654c8, topicName=伊匹木单抗)], attachment=null, authenticateStatus=null, createdAvatar=https://img.medsci.cn/Random/55971dc507c93968175ce7cc1e177b372a83869f.jpg, createdBy=f63e4754896, createdName=侠胆医心, createdTime=Sun Jun 11 01:22:12 CST 2023, time=2023-06-11, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111071, encodeId=f09d21110e1c1, content=学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://cdnapi.center.medsci.cn/medsci/head/2018/12/20/dafb36f63f4241903de36c3d053babb8.jpg, createdBy=d367105945, createdName=Midas, createdTime=Sat Jan 21 09:27:31 CST 2023, time=2023-01-21, status=1, ipAttribution=江苏省), GetPortalCommentsPageByObjectIdResponse(id=2111059, encodeId=50f6211105922, content=瘤内<a href='/topic/show?id=d17466492d5' target=_blank style='color:#2F92EE;'>#溶瘤病毒#</a>V937加<a href='/topic/show?id=597725653fd' target=_blank style='color:#2F92EE;'>#伊匹单抗#</a>治疗 晚期<a href='/topic/show?id=330410333110' target=_blank style='color:#2F92EE;'>#黑色素瘤#</a>的疗效,仍然从黑色素瘤入手,这是明智的。, beContent=null, objectType=article, channel=null, level=null, likeNumber=65, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=66492, encryptionId=d17466492d5, topicName=溶瘤病毒), TopicDto(id=25653, encryptionId=597725653fd, topicName=伊匹单抗), TopicDto(id=103331, encryptionId=330410333110, topicName=黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=8f0715, createdName=showtest, createdTime=Sat Jan 21 09:12:29 CST 2023, time=2023-01-21, status=1, ipAttribution=上海), GetPortalCommentsPageByObjectIdResponse(id=2111050, encodeId=714c211105092, content=不错,学习了。, beContent=null, objectType=article, channel=null, level=null, likeNumber=49, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=b08e8469269, createdName=ms4000000512201075, createdTime=Sat Jan 21 08:30:02 CST 2023, time=2023-01-21, status=1, ipAttribution=吉林省)]
    2023-01-21 ms4000000512201075 来自吉林省

    不错,学习了。

    0

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