本文由小咖机器人翻译整理

期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02986-9

摘要内容如下：

对于患有复发性/难治性（R/R）滤泡性淋巴瘤（FL）和高风险疾病特征（如一线免疫化疗后24个月内疾病进展（POD24）或对CD20靶向剂和烷化剂均难治的疾病（双重难治））的患者，由于没有建立治疗标准和预后不良，其需求未得到满足。嵌合抗原受体（CAR）T细胞治疗是R/R FL患者在接受两种或两种以上系统治疗后的一种选择，但其在FL病程中的最佳时机尚无共识，也没有对具有高危特征的患者进行二线（2L）治疗的数据。Lisocabtagene Maraleucel（Liso-Cel）是一种自体、CD19导向的4-1BB CAR T细胞产品。2期Transcend FL研究评估了R/R FL患者的LISO-CEL，包括2L患者，这些患者在接受抗CD20抗体和烷化剂治疗后，从诊断开始均为POD24，FL诊断≤6个月和/或符合改良滤泡性淋巴瘤研究组标准。主要/关键次要终点为独立审查委员会评估的总体缓解率（ORR）/完全缓解率（Cr）。在数据截止时，130名患者接受了LISO-CEL治疗（中位随访时间为18.9个月）。达到主要/关键次要终点。在三线或更晚的FL（n=101）中，ORR为97%（95%置信区间（CI）:91.6-99.4），CR率为94%（95%CI:87.5-97.8）。在2L FL（n=23）中，ORR为96%（95%CI:78.1~99.9）；所有应答者均达到Cr。58%的患者出现细胞因子释放综合征（≥3级，1%）；15%的患者发生神经系统事件（≥3级，2%）。LISO-CEL在R/R FL（包括高危2L FL）患者中显示出疗效和安全性。ClinicalTrials.gov标识符：NCT04245839。

英文原文如下：

Abstracts

An unmet need exists for patients with relapsed/refractory (R/R) follicular lymphoma (FL) and high-risk disease features, such as progression of disease within 24 months (POD24) from first-line immunochemotherapy or disease refractory to both CD20-targeting agent and alkylator (double refractory), due to no established standard of care and poor outcomes. Chimeric antigen receptor (CAR) T cell therapy is an option in R/R FL after two or more lines of prior systemic therapy, but there is no consensus on its optimal timing in the disease course of FL, and there are no data in second-line (2L) treatment of patients with high-risk features. Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, 4-1BB CAR T cell product. The phase 2 TRANSCEND FL study evaluated liso-cel in patients with R/R FL, including 2L patients who all had POD24 from diagnosis after treatment with anti-CD20 antibody and alkylator ≤6 months of FL diagnosis and/or met modified Groupe d'Etude des Lymphomes Folliculaires criteria. Primary/key secondary endpoints were independent review committee-assessed overall response rate (ORR)/complete response (CR) rate. At data cutoff, 130 patients had received liso-cel (median follow-up, 18.9 months). Primary/key secondary endpoints were met. In third-line or later FL (n = 101), ORR was 97% (95% confidence interval (CI): 91.6‒99.4), and CR rate was 94% (95% CI: 87.5‒97.8). In 2L FL (n = 23), ORR was 96% (95% CI: 78.1‒99.9); all responders achieved CR. Cytokine release syndrome occurred in 58% of patients (grade ≥3, 1%); neurological events occurred in 15% of patients (grade ≥3, 2%). Liso-cel demonstrated efficacy and safety in patients with R/R FL, including high-risk 2L FL. ClinicalTrials.gov identifier: NCT04245839 .

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