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Lisocabtagene maraleucel 用于复发/难治性大 B 细胞淋巴瘤:细胞治疗联盟真实世界分析

英文原题:Lisocabtagene maraleucel for relapsed/refractory large B-cell lymphoma: a cell therapy consortium real-world analysis.

查看英文原题

Lisocabtagene maraleucel for relapsed/refractory large B-cell lymphoma: a cell therapy consortium real-world analysis.

PubMed 2025/03/11(内容时间) Blood Adv Q1 · IF 7.7(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

中文摘要

Lisocabtagene maraleucel(liso-cel)是一种自体CD19靶向CAR-T 细胞疗法,已获批用于治疗复发/难治性大B细胞淋巴瘤。

我们开展了一项多中心回顾性研究,评估liso-cel在标准治疗环境中的安全性、疗效和资源使用情况。患者在7个美国医疗中心接受商业化liso-cel治疗,患者选择、毒性管理和疾病评估均遵循各机构实践。在101例接受输注的患者中,中位年龄为71岁(35%年龄≥75岁),68%的Charlson合并症指数评分≥3,10%有继发性中枢神经系统受累。既往治疗中位数为3线;由于合并症,33%的患者原本不符合TRANSCEND研究的入组条件。60%的患者使用了桥接治疗(43%接受了基于polatuzumab的治疗)。任何级别的细胞因子释放综合征发生于49%(3%为≥3级),任何级别的免疫效应细胞相关神经毒性综合征发生于26%(10%为≥3级)。桥接治疗的总体缓解率(ORR)为45%,其中18%达到完全缓解(CR)。liso-cel输注后,第90天ORR为66%(60% CR);中位随访15.5个月时,12个月无进展生存期(PFS)和总生存期(OS)分别为55%和68%。淋巴细胞清除前乳酸脱氢酶水平正常与PFS和OS改善相关。这些分析证实,商业化liso-cel的疗效和安全性与其关键试验结果相似。

值得注意的是,这些结局是在以高龄为主且伴有显著合并症的患者中实现的。结果也可能反映了患者选择、毒性管理以及新型桥接策略使用方面的进步。

展开英文摘要原文

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed chimeric antigen receptor T-cell therapy approved for the treatment of relapsed/refractory large B-cell lymphoma.

We present a multicenter retrospective study evaluating safety, efficacy, and resource use of liso-cel in the standard-of-care setting. Patients received commercial liso-cel at 7 US medical centers, and patient selection, toxicity management, and disease assessment followed institutional practices. Among 101 patients who received infusion, the median age was 71 years (35% aged ≥75 years), 68% had a Charlson comorbidity index score of ≥3, and 10% had secondary central nervous system involvement. Median number of prior therapies was 3; and because of comorbidities, 33% would have been ineligible for the TRANSCEND study. Bridging therapy was used in 60% (43% received polatuzumab-based treatment).

Any-grade cytokine-release syndrome occurred in 49% (3% grade ≥3) with any-grade immune effector cell-associated neurotoxicity syndrome occurring in 26% (10% grade ≥3). The overall response rate (ORR) to bridging therapy was 45%, with 18% achieving a complete response (CR). Following liso-cel infusion, the day 90 ORR was 66% (60% CR); and with a median follow-up of 15.

5 months, 12-month progression-free survival (PFS) and overall survival (OS) were 55% and 68%, respectively. A normal lactate dehydrogenase level before lymphodepletion was associated with improved PFS and OS. These analyses confirm similar efficacy and safety of commercial liso-cel compared with pivotal trial results.

Notably, these outcomes were achieved in patients predominantly of advanced age and with significant comorbidities. Results also likely reflect advancements in patient selection, toxicity management, and the use of novel bridging strategies.

论文信息

作者
Riedell PA、Grady CB、Nastoupil LJ、Luna A、Ahmed N、Maziarz RT、Hu M、Brower J
第一作者单位
David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago, IL.United States
通讯作者单位
Center for Cell Therapy and Transplant, University of Pennsylvania and Abramson Cancer Center, Philadelphia, PA.United States
文献类型
多中心研究
期刊
Blood advances2025 Mar 11
原文标识
PubMed 39657136 · DOI 10.1182/bloodadvances.2024014164