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

IF 3.9 4区医学 Q2 HEMATOLOGY Hematological Oncology Pub Date : 2025-03-19 DOI:10.1002/hon.70051

Fenghua Gao, Cong Sun, Jing Liu, Jingwei Yu, Jin He, Xiangrui Meng, Xia Liu, Xue Han, Lanfang Li, Lihua Qiu, Zhengzi Qian, Shiyong Zhou, Zhen Xia, Su Yang, Zisong Zhou, Alex Tian, Yun Qin, Xianhuo Wang, Huilai Zhang

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Abstract

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.

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与常规治疗相比，瑞马卡布基自体醇治疗复发/难治性滤泡性淋巴瘤的生存获益：一项匹配调整的间接分析

目前对复发/难治性（r/r）滤泡性淋巴瘤（FL）的治疗中，relmacabtagene自体白血病（relma-cel）的生存获益知之甚少。目前的研究在一项回顾性、观察性、大规模现实世界研究（RWS）中比较了中国FL患者在RELIANCE接受relma-cel治疗（NCT04089215）和常规治疗的生存结果。在中国，对来自RELIANCE的27例患者和来自RWS的53例患者进行了间接治疗比较。此外，还与SCHOLAR-5研究进行了直接比较，该研究评估了国外可用的治疗方案。倾向评分匹配后，relma- cell组的疾病状态（FLIPI2评分、组织学分级、复发状态、POD24）似乎表明，与常规治疗组相比，疾病更严重。然而，relma- cell的中位无进展生存期（PFS）未达到（95% CI 8.97-NR），而常规治疗的中位无进展生存期为19.98个月（95% CI 16.03-28.98），表明危险比（HR）为0.40 （95% CI 0.13-1.23）。此外，采用国外可用治疗方案的RELIANCE和SCHOLAR-5的比较分析显示，PFS的HR为0.20 （95% CI 0.07-0.58）。在24个月时，100%的患者在relma- cell输注后存活，而在中国，常规治疗后的存活率为38.2%，在SCHOLAR-5中，常规治疗后的存活率为62.7%。在≥2个治疗线后，Relma-cel在r/r FL患者中显示出优于当前常规治疗的生存益处。

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来源期刊

Hematological Oncology 医学-血液学

CiteScore

4.20

自引率

6.10%

发文量

147

审稿时长

>12 weeks

期刊介绍： Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged: -Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders -Diagnostic investigations, including imaging and laboratory assays -Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases -Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies -Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems. Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.