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ZUMA-5 五年随访分析:Axicabtagene Ciloleucel 治疗复发/难治性惰性非霍奇金淋巴瘤

英文原题:Five-Year Follow-Up Analysis of ZUMA-5: Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma.

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Five-Year Follow-Up Analysis of ZUMA-5: Axicabtagene Ciloleucel in Relapsed/Refractory Indolent Non-Hodgkin Lymphoma.

PubMed 2025/10/16(内容时间) J Clin Oncol Q1 · IF 44.7(JCR 2025)

研究概要

在此,我们报告 ZUMA-5 中 159 例入组 R/R 惰性非霍奇金淋巴瘤(iNHL;127 例 FL,31 例边缘区淋巴瘤)患者的更新临床结局,中位随访 64.6 个月。

中文摘要

Axicabtagene ciloleucel(axi-cel)是一种自体抗CD19嵌合抗原受体(CAR)T细胞疗法,已获批用于复发/难治性(R/R)滤泡性淋巴瘤(FL)。本文报告ZUMA-5研究的更新临床结局:159例入组的复发/难治性惰性非霍奇金淋巴瘤(iNHL)患者(其中127例为FL、31例为边缘区淋巴瘤),中位随访时间为64.6个月。患者接受白细胞单采、淋巴细胞清除化疗及axi-cel治疗(每千克体重2×10^6个CAR-T细胞)。总缓解率为90%(完全缓解率75%)。缓解持续时间中位数为60.4个月,无进展生存期(PFS)中位数为62.2个月;至下一次治疗的时间和总生存期中位数均未达到。数据截止时,55%的患者存活且未接受后续抗癌治疗。FL患者的淋巴瘤特异性PFS中位数未达到;34%的患者发生进展或因淋巴瘤或研究治疗而死亡。值得注意的是,输注30个月后,疾病进展或淋巴瘤相关死亡已很少见。迟发毒性不常见,且大多与axi-cel无关。FL患者的持久缓解和延长生存与早期CAR-T细胞强劲扩增及幼稚型产品表型相关。这些发现证实,对于复发/难治性iNHL患者,axi-cel可带来长期持续缓解,且安全性可控,并显示其在FL中具有潜在治愈作用。

展开英文摘要原文

Axicabtagene ciloleucel (axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory (R/R) follicular lymphoma (FL). Here, we report updated clinical outcomes from ZUMA-5 in 159 enrolled patients with R/R indolent non-Hodgkin lymphoma (iNHL; 127 with FL and 31 with marginal zone lymphoma) after a median follow-up of 64.6 months. Patients underwent leukapheresis and received lymphodepleting chemotherapy and axi-cel (2 10 6 CAR T cells/kg). The overall response rate was 90% (75% complete response rate). The median duration of response was 60.4 months, and the median progression-free survival (PFS) was 62.2 months; median time to next treatment and overall survival were not reached (NR). At data cutoff, 55% of patients were alive without requiring subsequent anticancer therapy. Median lymphoma-specific PFS in patients with FL was NR; 34% had progression or death due to lymphoma or study treatment. Notably, after 30 months postinfusion, progression or lymphoma-related deaths were rare. Late-onset toxicities were infrequent and largely unrelated to axi-cel. Durable response and prolonged survival in FL were associated with robust early CAR T-cell expansion and na ve product phenotype. These findings confirm sustained responses and manageable safety with axi-cel in the long term among patients with R/R iNHL and its potential as a curative therapy in FL.

论文信息

作者
Neelapu SS、Chavez JC、Sehgal AR、Epperla N、Ulrickson ML、Bachy E、Munshi PN、Casulo C
第一作者单位
The University of Texas MD Anderson Cancer Center, Houston, TX.United States
通讯作者单位
Dana-Farber Cancer Institute, Boston, MA.United States
文献类型
多中心研究 · 非美国政府资助研究
期刊
Journal of clinical oncology : official journal of the American Society of Clinical Oncology2025 Nov 20
原文标识
PubMed 41100801 · DOI 10.1200/JCO-25-00668