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瑞马卡布他基因自体白细胞介素治疗中国复发/难治性大B细胞淋巴瘤患者的长期疗效:RELIANCE研究的更新结果

Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study.

作者信息

Ying Zhitao, Yang Haiyan, Guo Ye, Li Wenyu, Zou Dehui, Zhou Daobin, Wang Zhao, Zhang Mingzhi, Wu Jianqiu, Liu Hui, Wang Chris, Ma Laura, Yang Su, Zhou Zisong, Qin Yun, Song Yuqin, Zhu Jun

机构信息

Department of Lymphoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China.

Department of Lymphoma, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou, China.

出版信息

Cytotherapy. 2023 May;25(5):521-529. doi: 10.1016/j.jcyt.2022.10.011. Epub 2023 Feb 24.


DOI:10.1016/j.jcyt.2022.10.011
PMID:36842849
Abstract

BACKGROUND AIMS: The RELIANCE study has demonstrated the activity and safety of relmacabtagene autoleucel (relma-cel) (JW Therapeutics [Shanghai] Co, Ltd, Shanghai, China), a CD19-targeted chimeric antigen receptor T-cell product, in patients with heavily pre-treated relapsed/refractory large B-cell lymphoma (r/r LBCL). This study aimed to report the updated 2-year data of the RELIANCE study. METHODS: The RELIANCE study (NCT04089215) was an open-label, multi-center, randomized, phase 1/2 registrational clinical trial conducted at 10 clinical sites in China. Adult patients with heavily pre-treated r/r LBCL were enrolled and received lymphodepletion chemotherapy followed by infusion of 100 × 10 or 150 × 10 relma-cel. The primary endpoint was objective response rate (ORR) at 3 months, as assessed by investigators. Secondary endpoints were duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety profiles. RESULTS: From November 2017 to January 2022, a total of 68 patients were enrolled, and 59 patients received relma-cel infusion. As of March 29, 2022, a total of 59 patients had a median follow-up of 17.9 months (range, 0.3-25.6). ORR was 77.59% (95% confidence interval [CI], 64.73-87.49) and complete response rate was 53.45% (95% CI, 39.87-66.66). Median DoR was 20.3 months (95% CI, 4.86-not reached [NR]) and median PFS was 7.0 months (95% CI, 4.76-24.15). Median OS was NR and 1-year and 2-year OS rates were 75.0% and 69.3%, respectively. Three (5.1%) patients experienced grade ≥3 cytokine release syndrome and two (3.4%) patients had grade ≥3 neurotoxicity. CONCLUSIONS: The updated data of the RELIANCE study demonstrate durable response with and manageable safety profile of relma-cel in patients with heavily pre-treated r/r LBCL.

摘要

背景与目的:RELIANCE研究已证实靶向CD19的嵌合抗原受体T细胞产品relmacabtagene autoleucel(relma-cel,上海君赛生物科技有限公司,中国上海)在经过大量前期治疗的复发/难治性大B细胞淋巴瘤(r/r LBCL)患者中的活性和安全性。本研究旨在报告RELIANCE研究的最新2年数据。 方法:RELIANCE研究(NCT04089215)是一项在中国10个临床地点进行的开放标签、多中心、随机、1/2期注册临床试验。纳入经过大量前期治疗的r/r LBCL成年患者,接受淋巴细胞清除化疗,随后输注100×10⁶或150×10⁶的relma-cel。主要终点为3个月时的客观缓解率(ORR),由研究者评估。次要终点为缓解持续时间(DoR)、无进展生存期(PFS)、总生存期(OS)和安全性。 结果:2017年11月至2022年1月,共纳入68例患者,59例患者接受了relma-cel输注。截至2022年3月29日,59例患者的中位随访时间为17.9个月(范围0.3 - 25.6个月)。ORR为77.59%(95%置信区间[CI],64.73 - 87.49),完全缓解率为53.45%(95% CI,39.87 - 66.66)。中位DoR为20.3个月(95% CI,4.86 - 未达到[NR]),中位PFS为7.0个月(95% CI,4.76 - 24.15)。中位OS未达到,1年和2年OS率分别为75.0%和69.3%。3例(5.1%)患者发生≥3级细胞因子释放综合征,2例(3.4%)患者发生≥3级神经毒性。 结论:RELIANCE研究的最新数据表明,relma-cel在经过大量前期治疗的r/r LBCL患者中具有持久缓解效果且安全性可控。

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