研究动态
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T细胞结合双特异性抗体tebentafusp不良事件管理的实用指南。

Practical guidelines for the management of adverse events of the T cell engager bispecific tebentafusp.

发表日期:2023 Jul 11
作者: Jessica C Hassel, Carola Berking, Andrea Forschner, Christoffer Gebhardt, Lucie Heinzerling, Friedegund Meier, Sebastian Ochsenreither, Jens Siveke, Axel Hauschild, Dirk Schadendorf
来源: Experimental Hematology & Oncology

摘要:

Tebentafusp是一种新的T细胞受体双特异性融合蛋白,也是第一个针对人白细胞抗原-A*02:01 (HLA-A*02:01)转移性葡萄膜黑色素瘤的获准治疗选项,已经证实与研究者选择相比,在总生存率方面具有益处。作为一种首创的治疗选择,这种免疫动员的单克隆T细胞受体抗癌物质(ImmTAC)与新的不良事件(AE)谱系相关。根据临床经验,一个国家专家组讨论了关于tebentafusp治疗的建议,重点是AE管理。进一步的话题包括启动tebentafusp治疗的先决条件、适当的治疗环境和病人选择标准。为了为治疗医生提供指导,总结了由此产生的建议,包括AE管理的模型标准操作程序。处于良好临床状况且肿瘤负担较轻的患者是接受tebentafusp治疗的好候选人,特别是在转移性疾病确诊后尽早治疗。tebentafusp的安全性可控,包括两个主要病理:细胞因子释放综合征(CRS)和与皮肤相关的事件。因此,应该侧重于监测发热和低血压作为细胞因子释放的首要症状。为了降低与CRS相关的低血压风险,患者应在开始治疗前接受静脉注射液。肝功能值的监测至关重要,因为患者可能会出现转氨酶的增加,甚至可能表现为肿瘤溶解综合症。版权所有 © 2023作者。Elsevier Ltd.保留所有权利。
Tebentafusp is a new T cell receptor bispecific fusion protein and the first approved treatment option for human leucocyte antigen-A*02:01 (HLA-A*02:01) metastatic uveal melanoma, with a proven benefit in overall survival versus the investigator's choice. As a first-in-class therapeutic option, this Immune mobilising monoclonal T cell receptor Against Cancer (ImmTAC) is associated with a new adverse event (AE) profile. Based on clinical experience, a national expert group discussed recommendations for tebentafusp treatment, focusing on AE management. Further topics included prerequisites for initiating tebentafusp treatment, appropriate treatment setting, and patient selection criteria. To provide guidance for treating physicians, the resulting recommendations are summarised including a model standard operating procedure for AE management. Patients in good clinical condition and with a low tumour burden are good candidates for tebentafusp treatment, particularly if treated as early as possible after the diagnosis of metastatic disease. The safety profile of tebentafusp is manageable and includes two major pathologies: cytokine release syndrome (CRS) and skin-related events. Postdose monitoring should thus focus on pyrexia and hypotension as the first symptoms of cytokine release. To minimise the risk of hypotension associated with CRS, patients should receive intravenous fluids before starting treatment. The monitoring of liver values is crucial, as patients may experience an increase in transaminases, which can even manifest as tumour lysis syndrome.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.