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Lifileucel:为晚期黑色素瘤新疗法带来曙光

英文原题:Lifileucel: Shedding Light on a New Treatment for Advanced Melanoma.

PubMed 2026/05/08(内容时间) Rev Recent Clin Trials Q4 · IF 1.2(JCR 2025)

研究概要

在接受推荐剂量治疗的 73 例患者中,客观缓解率为 31.5%,其中 4.1% 达到完全缓解,27.4% 达到部分缓解。

中文摘要

Lifileucel 是一种来源于肿瘤的自体 T 细胞疗法,已获批用于成人不可切除或转移性黑色素瘤。本文讨论 lifileucel 治疗晚期黑色素瘤的 10 项临床研究。现有 II 期研究数据评估了一项全球多中心研究中 lifileucel 的安全性和疗效;研究纳入既往接受过全身治疗(包括 PD-1 阻断抗体,以及适用时 BRAF 和 MEK 抑制剂)的不可切除或转移性黑色素瘤成人患者。在接受推荐剂量治疗的 73 名患者中,客观缓解率为 31.5%;4.1% 达到完全缓解,27.4% 达到部分缓解。在应答者中,分别有 56.5%、47.8% 和 43.5% 于 6、9 和 12 个月时仍维持应答且未发生疾病进展或死亡。临床研究中最常见的不良事件包括血小板减少、贫血和发热性中性粒细胞减少。更多研究正在进行,以进一步评估 lifileucel 作为不可切除或转移性黑色素瘤安全有效静脉治疗选择的证据。本文回顾 lifileucel 的已发表数据,涵盖其早期开发、药理学、疗效和安全性。

展开英文摘要原文

Lifileucel is a tumor-derived autologous T cell therapy approved for unresectable or metastatic melanoma in adults. This article discusses 10 clinical studies on lifileucel for the treatment of advanced melanoma. The phase II study data available evaluated the safety and efficacy of lifileucel in a global, multicenter study involving adult patients with unresectable or metastatic melanoma who had previously received systemic therapies, including a PD-1 blocking antibody and, if applicable, BRAF and MEK inhibitors. Among 73 patients treated with the recommended dose, the objective response rate was 31.5%, with 4.1% achieving a complete response and 27.4% a partial response. Of the responders, 56.5%, 47.8%, and 43.5% maintained their responses without progression or death at 6, 9, and 12 months, respectively. The most common adverse events seen in clinical studies include thrombocytopenia, anemia, and febrile neutropenia. Additional studies are underway to provide further data on the use of lifileucel as a safe and effective intravenous treatment option for unresectable or metastatic melanoma. This article reviews the published data encompassing the preliminary development, pharmacology, efficacy, and safety of lifileucel.

论文信息

作者
Genovese A、Ashchi Lachapelle A、Ashchi A、Corona K、Carpenter L、Valdes A、Kumar A、Huston J
第一作者单位
Florida State University College of Medicine, 1115 W Call St, Tallahassee, FL 32304, USA.United States
通讯作者单位
Department of Pharmacy Education and Practice, College of Pharmacy, University of Florida, Jacksonville, FL, USA.United States
期刊
Reviews on recent clinical trials2026 May 8
原文标识
PubMed 42136479 · DOI 10.2174/0115748871444837260417095431