N Engl J Med 2021:转移性葡萄膜黑色素瘤患者接受tebentafusp治疗的总生存获益

2021-10-27 MedSci原创 MedSci原创

葡萄膜黑色素瘤是成人最常见的眼内恶性肿瘤,此类患者的预后很差;中位总生存期约为1年,目前缺乏关于全身治疗生存获益的数据。

葡萄膜黑色素瘤是成人最常见的眼内恶性肿瘤,占所有黑色素瘤的3%~5% 。虽然葡萄膜黑色素瘤起源于黑色素细胞,但它与皮肤黑色素瘤有差异,两者具有不同的分子驱动因素和转移模式,以及不同的肿瘤-免疫微环境。目前认为这些差异导致葡萄膜黑色素瘤患者接受全身性治疗(包括免疫检查点抑制疗法)后的临床疗效不佳。多达50%的葡萄膜黑色素瘤患者会出现转移,转移部位主要是肝脏,而此类患者的预后很差;中位总生存期约为1年,目前缺乏关于全身治疗生存获益的数据。

被称为抗癌免疫动员单克隆 T 细胞受体 (ImmTAC) 的分子是一类新的 T 细胞重定向双特异性融合蛋白,它使用工程化的高亲和力 T 细胞受体靶向任何蛋白质,包括细胞内抗原,即以肽-HLA 复合物的形式出现在靶细胞表面。Tebentafusp(以前称为 IMCgp100)由可溶性亲和力增强的 HLA-A*02:01 限制性 T 细胞受体组成,该受体对糖蛋白 100 (gp100) 肽 YLEPGPVTA 具有特异性,并与抗 CD3 单-链可变片段。一旦 ImmTAC 分子与靶细胞表面的特定肽-HLA 复合物结合,它们就会通过 CD3 募集并激活多克隆 T 细胞,以释放针对靶细胞的细胞因子和溶细胞介质。

在一项涉及 127 名先前接受过治疗的转移性葡萄膜黑色素瘤患者的单组 2 期研究中,tebentafusp 单药治疗显示出比历史对照更有希望的总生存期。观察到根据实体瘤疗效评价标准 (RECIST) 1.1 版定义的传统疗效,但该替代终点未能充分预测长期生存获益。临床益处包括惰性肿瘤生长和缓慢的肿瘤缩小。在这项多中心、随机、3 期试验中,我们将 tebentafusp 与研究者选择的治疗方法作为转移性葡萄膜黑色素瘤患者的一线全身治疗进行了比较。

实验方法:

患者以 2:1 的比例随机分配接受 tebentafusp(tebentafusp 组)或研究者选择的单药派姆单抗、易普利姆玛或达卡巴嗪治疗(对照组)。先前已证明患者内增加 tebentafusp 的剂量可减少毒性作用。因此,患者在第 1 天以 20 μg、第 8 天 30 μg 和此后每周 68 μg 的剂量接受静脉注射替苯他福司。在治疗后的前 3 周,在剂量递增期间对患者进行整夜监测。在每个 21 天周期的第 1 天,以每公斤体重 2 毫克至每剂最大 200 毫克的剂量静脉内给予派姆单抗,或(如果当地批准)以 200 毫克的固定剂量静脉给药。伊匹单抗在每个 21 天周期的第 1 天以 3 mg/kg 的剂量静脉内给药,最多四剂。达卡巴嗪在每个 21 天周期的第 1 天以每平方米体表面积 1000 毫克的剂量静脉内给药。根据集中评估的乳酸脱氢酶 (LDH) 状态(LDH 水平高于正常范围上限 [ULN] 或 LDH 水平小于或等于 ULN)对随机化进行分层。

终点和评估

主要终点是事件时间分析中评估的总生存期。一项 2 期研究表明皮疹与存活率之间存在关联,17与对照组中的所有患者相比,我们对在 tebentafusp 治疗开始后 1 周内出现任何级别皮疹的 tebentafusp 组患者的总生存期进行了预先指定的分析。

次要终点包括疾病控制(定义为完全缓解、部分缓解或疾病稳定≥12 周,根据 RECIST 1.1 版)、客观缓解(定义为完全缓解或部分缓解,根据 RECIST 1.1 版)、在事件时间分析中评估的无进展生存期和安全性。所有次要终点均由了解治疗分配的研究人员评估。

结果:

总共 378 名患者被随机分配到 tebentafusp 组(252 名患者)或对照组(126 名患者)。在意向治疗中,tebentafusp 组的 1 年总生存率为 73%,对照组为 59%(死亡风险比,0.51;95% 置信区间 [CI],0.37 至 0.71;P<0.001)人口。tebentafusp 组的无进展生存期也显着高于对照组(6 个月时为 31% 与 19%;疾病进展或死亡的风险比,0.73;95% CI,0.58 至 0.94;P=0.01) . tebentafusp 组中最常见的治疗相关不良事件是细胞因子介导的事件(由于 T 细胞激活)和皮肤相关事件(由于糖蛋白 100 阳性黑素细胞),包括皮疹 (83%)、发热 (76 %) 和瘙痒 (69%)。在前三或四次给药后,这些不良事件的发生率和严重程度有所降低,并且很少导致试验治疗中止 (2%)。没有报告与治疗相关的死亡。

在先前未治疗的转移性葡萄膜黑色素瘤患者中,用 tebentafusp 治疗导致总生存期比对照治疗更长。

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    2022-03-05 sunylz
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topicList=[TopicDto(id=17244, encryptionId=8f501e24475, topicName=tebentafusp)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=8e886, createdName=仁者大医, createdTime=Thu Jun 09 03:35:45 CST 2022, time=2022-06-09, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1785558, encodeId=7d281e85558d7, content=<a href='/topic/show?id=34b86e91f9' target=_blank style='color:#2F92EE;'>#Engl#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=50, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=6791, encryptionId=34b86e91f9, topicName=Engl)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=7eeb2500172, createdName=haouestc, createdTime=Mon Sep 12 08:35:45 CST 2022, time=2022-09-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2006971, encodeId=819320069e1ff, 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=42, 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=Sun Jul 31 20:35:45 CST 2022, time=2022-07-31, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1386864, encodeId=807513868640f, 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=25, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425955, encodeId=a84714259555e, 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=55, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559101, encodeId=c8b415591014c, 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=29, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565110, encodeId=314d156511019, 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=23, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=)]
    2022-01-29 docwu2019
  4. [GetPortalCommentsPageByObjectIdResponse(id=1645389, encodeId=e716164538904, 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=39, 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=Mon May 16 07:35:45 CST 2022, time=2022-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680769, encodeId=4a1d1680e69a8, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, 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  5. [GetPortalCommentsPageByObjectIdResponse(id=1645389, encodeId=e716164538904, 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=39, 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=Mon May 16 07:35:45 CST 2022, time=2022-05-16, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1680769, encodeId=4a1d1680e69a8, content=<a href='/topic/show?id=9e5c86e0712' target=_blank style='color:#2F92EE;'>#色素#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=86707, encryptionId=9e5c86e0712, topicName=色素)], attachment=null, authenticateStatus=null, createdAvatar=null, 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time=2021-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1425955, encodeId=a84714259555e, 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=55, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1559101, encodeId=c8b415591014c, 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=29, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1565110, encodeId=314d156511019, 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=23, 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=Fri Oct 29 09:35:45 CST 2021, time=2021-10-29, status=1, ipAttribution=)]
    2022-09-12 haouestc
  6. 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  7. 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  8. 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  9. 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