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relmacabtagene autoleucel 对比常规治疗在复发/难治性滤泡性淋巴瘤中的生存获益:一项匹配调整间接分析

英文原题:Survival Benefit of Relmacabtagene Autoleucel Versus Usual Care in Relapsed/Refractory Follicular Lymphoma: A Matching-Adjusted Indirect Analysis.

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Survival Benefit of Relmacabtagene Autoleucel Versus Usual Care in Relapsed/Refractory Follicular Lymphoma: A Matching-Adjusted Indirect Analysis.

PubMed 2025/03/01(内容时间) Hematol Oncol Q1 · IF 4.1(JCR 2025)

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中文摘要

在当前复发/难治性(R/R)滤泡性淋巴瘤(FL)治疗格局中,瑞基奥仑赛(relmacabtagene autoleucel,relma-cel)的生存获益尚不清楚。

本研究在一项回顾性、观察性、大规模真实世界研究(RWS)中,比较中国 FL 患者在 RELIANCE 试验(NCT04089215)接受 relma-cel 与接受常规治疗的生存结局。研究对中国 RELIANCE 试验中的 27 例患者和 RWS 中的 53 例患者进行了间接治疗比较。

此外,还与评估海外现有治疗选择的 SCHOLAR-5 研究进行直接比较。倾向评分匹配后,relma-cel 组的疾病状态(FLIPI2 评分、组织学分级、复发状态、24 个月内进展[POD24])似乎比常规治疗组更严重。尽管如此,relma-cel 组的 PFS 中位数尚未达到(95% CI 8.97–未达到),常规治疗组为 19.98 个月(95% CI 16.03–28.98),风险比(HR)为 0.40(95% CI 0.13–1.23)。

此外,比较 RELIANCE 与 SCHOLAR-5 并采用海外现有治疗方案的分析显示,PFS 的 HR 为 0.20(95% CI 0.07–0.58)。24 个月时,relma-cel 输注后患者生存率为 100%;中国常规治疗后为 38.2%,SCHOLAR-5 常规治疗后为 62.7%。对接受过两线治疗的 R/R FL 患者而言,与当前常规疗法相比,relma-cel 显示出更优的生存获益。

展开英文摘要原文

Little is known about the survival benefit of relmacabtagene autoleucel (relma-cel) in the current therapeutic landscape of relapsed/refractory (r/r) follicular lymphoma (FL). The current study compared the survival outcomes of Chinese FL patients administered relma-cel in RELIANCE (NCT04089215) and usual care in a retrospective, observational, large-scale real-world study (RWS). An indirect treatment comparison was carried out for 27 patients from RELIANCE and 53 patients from the RWS in China.

Additionally, a direct comparison was made with the SCHOLAR-5 study, which assessed available treatment options abroad. After propensity score matching, disease status (FLIPI2 score, histological grade, relapse status, POD24) in the relma-cel group appeared to indicate more severe disease versus the usual care group. Nevertheless, median progression-free survival (PFS) was not reached (95% CI 8. 97-NR) for relma-cel versus 19. 98 months (95% CI 16. 03-28. 98) for usual care, indicating a hazard ratio (HR) of 0.

40 (95% CI 0. 13-1. 23). Besides, a comparative analysis of RELIANCE and SCHOLAR-5, applying available treatment options abroad, revealed an HR for PFS of 0. 20 (95% CI 0. 07-0. 58). At 24 months, 100% of patients survived after relma-cel infusion, versus 38. 2% after usual care in China and 62. 7% after usual care treatment in SCHOLAR-5, respectively. Relma-cel exhibits superior survival benefits versus current conventional therapies in r/r FL patients after 2 treatment lines.

论文信息

作者
Gao F、Sun C、Liu J、Yu J、He J、Meng X、Liu X、Han X
单位
Department of Lymphoma and National Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, the Sino-US Center for Lymphoma and Leukemia Research, Tianjin, China.China
文献类型
观察性研究 · 对照研究
期刊
Hematological oncology2025 Mar
原文标识
PubMed 40104957 · DOI 10.1002/hon.70051