肿瘤细胞治疗研究
英文原题：Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial.
Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial.
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在先前一项关于 tisagenlecleucel 治疗 r/r 滤泡性淋巴瘤（FL）的初步研究中，71% 的患者达到了完全缓解（CR）。
Tisagenlecleucel是一种自体抗CD19CAR-T 细胞疗法，在复发/难治性（r/r）B细胞淋巴瘤患者中已显示出具有临床意义的结局。在此前一项针对r/r滤泡性淋巴瘤（FL）的tisagenlecleucel初步研究中，71%的患者达到完全缓解（CR）。在此，我们报告ELARA 2期多国试验的主要预设中期分析结果，该试验评估tisagenlecleucel用于接受过两线或以上治疗或自体干细胞移植后复发的成人r/r FL患者（编号NCT03568461）。主要终点为CR率（CRR）。次要终点包括总缓解率（ORR）、缓解持续时间、无进展生存期、总生存期、药代动力学和安全性。截至2021年3月29日，98例入组患者中有97例接受了tisagenlecleucel治疗（中位随访时间16.59个月；四分位距13.8-20.21）。主要终点已达到。在疗效集（n = 94）中，CRR为69.1%（95%置信区间58.8-78.3），ORR为86.2%（95%置信区间77.5-92.4）。在安全性集（n = 97）中，输注后8周内，细胞因子释放综合征发生率为48.5%（≥3级，0%），神经系统事件为37.1%（≥3级，3%），免疫效应细胞相关神经毒性综合征（ICANS）为4.1%（≥3级，1%），无治疗相关死亡。Tisagenlecleucel在经大量既往治疗的r/r FL中安全有效，包括在高危患者中。
Tisagenlecleucel is an autologous anti-CD19 chimeric antigen receptor-T cell therapy with clinically meaningful outcomes demonstrated in patients with relapsed/refractory (r/r) B-cell lymphoma. In a previous pilot study of tisagenlecleucel in r/r follicular lymphoma (FL), 71% of patients achieved a complete response (CR). Here we report the primary, prespecified interim analysis of the ELARA phase 2 multinational trial of tisagenlecleucel in adults with r/r FL after two or more treatment lines or who relapsed after autologous stem cell transplant (no. NCT03568461). The primary endpoint was CR rate (CRR). Secondary endpoints included overall response rate (ORR), duration of response, progression-free survival, overall survival, pharmacokinetics and safety. As of 29 March 2021, 97/98 enrolled patients received tisagenlecleucel (median follow-up, 16.59 months; interquartile range, 13.8-20.21). The primary endpoint was met. In the efficacy set (n = 94), CRR was 69.1% (95% confidence interval, 58.8-78.3) and ORR 86.2% (95% confidence interval, 77.5-92.4). Within 8 weeks of infusion, rates of cytokine release syndrome were 48.5% (grade ≥3, 0%), neurological events 37.1% (grade ≥3, 3%) and immune effector cell-associated neurotoxicity syndrome (ICANS) 4.1% (grade ≥3, 1%) in the safety set (n = 97), with no treatment-related deaths. Tisagenlecleucel is safe and effective in extensively pretreated r/r FL, including in high-risk patients.
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