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纳武利尤单抗/雷莫芦单抗:不可切除或转移性黑色素瘤免疫检查点抑制剂治疗的新选择。

Nivolumab/Relatlimab: A Novel Addition to Immune Checkpoint Inhibitor Therapy in Unresectable or Metastatic Melanoma.

机构信息

College of Pharmacy and Health Sciences, Butler University, Indianapolis, IN, USA.

Franciscan Health Indianapolis, Indianapolis, IN, USA.

出版信息

Ann Pharmacother. 2023 Jun;57(6):738-745. doi: 10.1177/10600280221131396. Epub 2022 Oct 21.

Abstract

OBJECTIVE

The aim of this article is to assess available data regarding use of nivolumab/relatlimab for adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.

DATA SOURCES

A search of PubMed conducted from August 2019 to August 2022 with the search terms , , and resulted in 14 publications.

STUDY SELECTION AND DATA EXTRACTION

Relevant clinical trials written in English language were analyzed.

DATA SYNTHESIS

Nivolumab/relatlimab was approved by the Food and Drug Administration following results of a phase 1/2 trial and phase 2/3 RELATIVITY-047 trial. Nivolumab/relatlimab demonstrated a median progression free survival (PFS) of 10.1 months in the first-line setting without new safety signals. The PFS benefits appear greatest in those with programmed cell death-ligand 1 (PD-L1) <1% and lymphocyte activation gene-3 (LAG-3) ≥1%. Adverse effects commonly experienced were immune related in nature and require early identification and prompt management. Grade 3 or 4 adverse effects occurred in 18.9% of patients.

RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE

For patients 12 years of age and older with unresectable or metastatic melanoma, nivolumab/relatlimab offers a new first-line treatment option. Evaluation of PD-L1 expression along with concomitant use of medications with potential interactions should be evaluated when deciding if nivolumab/relatlimab is the most appropriate treatment option.

CONCLUSIONS

Nivolumab/relatlimab adds an additional first-line treatment option demonstrating promising improved PFS for patients with unresectable or metastatic melanoma, particularly those with PD-L1 <1% and/or LAG 3 ≥1%. Additional uses of nivolumab/relatlimab may be on the horizon as further clinical trials are ongoing.

摘要

目的

本文旨在评估纳武利尤单抗/relatlimab 用于 12 岁及以上不可切除或转移性黑色素瘤成人和儿科患者的现有数据。

资料来源

2019 年 8 月至 2022 年 8 月,通过搜索术语 、 、 ,在 PubMed 中进行了搜索,共产生了 14 篇出版物。

研究选择和数据提取

分析了以英文撰写的相关临床试验。

数据综合

纳武利尤单抗/relatlimab 在一项 1/2 期试验和 2/3 期 RELATIVITY-047 试验的结果后,获得了美国食品和药物管理局的批准。纳武利尤单抗/relatlimab 在一线治疗中未显示出新的安全信号,中位无进展生存期(PFS)为 10.1 个月。在程序性死亡配体 1(PD-L1)<1%和淋巴细胞激活基因-3(LAG-3)≥1%的患者中,PFS 获益最大。常见的不良反应是免疫相关的,需要早期识别和及时处理。3 级或 4 级不良反应发生率为 18.9%。

与患者护理和临床实践的相关性

对于 12 岁及以上的不可切除或转移性黑色素瘤患者,纳武利尤单抗/relatlimab 提供了一种新的一线治疗选择。在决定纳武利尤单抗/relatlimab 是否是最合适的治疗选择时,应评估 PD-L1 表达的评估以及同时使用可能有相互作用的药物。

结论

纳武利尤单抗/relatlimab 增加了一种新的一线治疗选择,为不可切除或转移性黑色素瘤患者,特别是 PD-L1<1%和/或 LAG 3≥1%的患者,提供了有希望的改善 PFS。随着进一步的临床试验正在进行,纳武利尤单抗/relatlimab 的其他用途可能即将出现。

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