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NEJM:转移性葡萄膜黑色素瘤采用Tebentafusp治疗的总生存获益

2021-11-09 Nebula MedSci原创

与对照治疗相比,Tebentafusp治疗延长了既往未治疗过的转移性葡萄膜黑色素瘤患者的总生存期

葡萄膜黑色素瘤是一种不同于皮肤黑色素瘤的疾病,是成人最常见的眼内恶性肿瘤,占所有黑色素瘤的3%~5%。葡萄膜黑色素瘤具有较低的肿瘤突变负荷,转移性葡萄膜黑色素瘤患者的1年总生存率约为50%。目前尚无关于患者接受全身性治疗后的总生存获益的数据。

Tebentafusp是一种双特异性蛋白,由亲和力强化的T细胞受体与抗CD3效应体融合而成,可将T细胞重定向去靶向糖蛋白100阳性的细胞。

本研究是一项开放标签的3期临床试验,招募了既往未治疗过的HLA-A*02:01阳性的转移性葡萄膜黑色素瘤患者,随机分成了两组(2:1),分别接受Tebentafusp(tebentafusp组)或研究者所选的治疗方案(帕博利珠单抗、伊匹木单抗或达卡巴嗪单药治疗)(对照组),并根据乳酸脱氢酶水平进行分层。主要终点是总生存期。

意向治疗人群的总生存期

共378位患者被随机分至两组:Tebentafusp组 252位,对照组 126位。在意向治疗人群中,Tebentafusp组和对照组的1年总生存率分别为73%和59%(死亡的风险比 0.51;95%CI,0.37~0.71;P<0.001)。Tebentafusp组的无进展生存率也显著优于对照组(6个月:31% vs 19%;疾病进展或死亡的风险比 0.73;95% CI,0.58~0.94;P=0.01)。

意向治疗人群的无进展生存期

Tebentafusp组最常见的治疗相关不良事件有细胞因子介导的事件(因T细胞活化)和皮肤相关事件(因糖蛋白100阳性黑色素细胞),包括皮疹(83%)、发热(76%)和瘙痒(69%)。前三次或前四次给药后,这些不良事件的发生率降低,严重程度减轻,并且很少导致试验治疗停药(2%)。无治疗相关死亡。

治疗相关不良事件的发生率变化

总而言之,与对照治疗相比,Tebentafusp治疗延长了既往未治疗过的转移性葡萄膜黑色素瘤患者的总生存期。

原始出处:

Paul Nathan, et al. Overall Survival Benefit with Tebentafusp in Metastatic Uveal Melanoma. N Engl J Med 2021; 385:1196-1206. DOI: 10.1056/NEJMoa2103485

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    2021-11-12 sunylz
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    2022-01-18 12137869m23(暂无昵称)

    学习学习

    0

  4. [GetPortalCommentsPageByObjectIdResponse(id=1680771, encodeId=f1451680e7150, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=343027846633, createdName=sunylz, createdTime=Fri Nov 12 13:43:14 CST 2021, time=2021-11-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1678116, encodeId=680016e811643, content=<a href='/topic/show?id=8f501e24475' target=_blank style='color:#2F92EE;'>#tebentafusp#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=47, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=17244, encryptionId=8f501e24475, topicName=tebentafusp)], attachment=null, authenticateStatus=null, createdAvatar=null, 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createdAvatar=http://thirdwx.qlogo.cn/mmopen/vi_32/Oiaecicujl2wfpBkKyhZ6gwISPy9rBt6nOxLXG0QhflNATVnicPmib6zX885nmcdZh0mEqTbaSWeftY7CcwDnSvduw/132, createdBy=bca42490282, createdName=米师, createdTime=Tue Jan 04 10:11:41 CST 2022, time=2022-01-04, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006972, encodeId=b3ac20069e2b9, content=<a href='/topic/show?id=52ad6902144' target=_blank style='color:#2F92EE;'>#生存获益#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=69021, encryptionId=52ad6902144, topicName=生存获益)], attachment=null, authenticateStatus=null, createdAvatar=https://thirdqq.qlogo.cn/qqapp/1103841572/EFCEF19303EB52B3F41B30C45995AF2C/100, createdBy=8e712500159, createdName=ms8538335253054589, createdTime=Thu Feb 17 08:43:14 CST 2022, time=2022-02-17, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1645390, encodeId=505b16453902e, content=<a href='/topic/show?id=23929343ee9' target=_blank style='color:#2F92EE;'>#转移性葡萄膜黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=36, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=93437, encryptionId=23929343ee9, topicName=转移性葡萄膜黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=1c6123209017, createdName=yeye5224620, createdTime=Sun Jan 16 10:43:14 CST 2022, time=2022-01-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386871, encodeId=065913868e1f1, 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=39, 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=Thu Nov 11 09:43:14 CST 2021, time=2021-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425956, encodeId=675114259563f, content=<a href='/topic/show?id=588988285e6' target=_blank style='color:#2F92EE;'>#葡萄膜黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88285, encryptionId=588988285e6, topicName=葡萄膜黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a4394020991, createdName=360611841, createdTime=Thu Nov 11 09:43:14 CST 2021, time=2021-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559103, encodeId=120b155910369, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Thu Nov 11 09:43:14 CST 2021, time=2021-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565112, encodeId=bb47156511243, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=37, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=150614999302, createdName=cqlidoudou, createdTime=Thu Nov 11 09:43:14 CST 2021, time=2021-11-11, status=1, ipAttribution=)]
    2022-01-04 米师

    谢谢分享

    0

  5. 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  6. 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09:43:14 CST 2021, time=2021-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425956, encodeId=675114259563f, content=<a href='/topic/show?id=588988285e6' target=_blank style='color:#2F92EE;'>#葡萄膜黑色素瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=61, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=88285, encryptionId=588988285e6, topicName=葡萄膜黑色素瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a4394020991, createdName=360611841, createdTime=Thu Nov 11 09:43:14 CST 2021, time=2021-11-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559103, encodeId=120b155910369, content=<a href='/topic/show?id=e27610332666' target=_blank style='color:#2F92EE;'>#黑色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=40, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=103326, encryptionId=e27610332666, topicName=黑色素)], 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  7. 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  8. 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  9. 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