小柯机器人

科学家完成tisagenlecleucel治疗成人复发或难治性滤泡性淋巴瘤的2期ELARA试验
2021-12-24 23:31
来源：小柯机器人

美国德州大学MD安德森癌症中心Nathan Hale Fowler等研究人员完成tisagenlecleucel治疗成人复发或难治性滤泡性淋巴瘤的2期ELARA试验。相关论文于2021年12月17日在线发表于国际学术期刊《自然—医学》。

研究人员表示，tisagenlecleucel是一种自体抗CD19嵌合抗原受体-T细胞疗法，在复发/难治性（r/r）B细胞淋巴瘤患者中显示出有临床意义的结果。在以前对tisagenlecleucel治疗r/r滤泡性淋巴瘤（FL）的试验研究中，71%的患者获得了完全反应（CR）。
 
研究人员报告了ELARA 2期多国tisagenlecleucel试验的主要、预先指定的中期分析，该试验是针对经过两个或更多治疗线或在自体干细胞移植后复发的r/r FL成人患者（编号：NCT03568461）。主要终点是CR率（CRR）。次要终点包括总反应率（ORR）、反应持续时间、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，97/98名入组患者接受了tisagenlecleucel（中位随访，16.59个月；四分位数范围，13.8-20.21）。主要终点已经达到。在疗效方面（n=94），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）。在输液的8周内，安全组（n=97）中，细胞因子释放综合征的比率为48.5%（≥3级，0%），神经系统事件为37.1%（≥3级，3%），免疫效应细胞相关的神经毒性综合征（ICANS）为4.1%（≥3级，1%），没有治疗相关的死亡。Tisagenlecleucel对广泛预处理的r/r FL是安全和有效的，包括高风险患者。
 
附：英文原文

Title: Tisagenlecleucel in adult relapsed or refractory follicular lymphoma: the phase 2 ELARA trial

Author: Fowler, Nathan Hale, Dickinson, Michael, Dreyling, Martin, Martinez-Lopez, Joaquin, Kolstad, Arne, Butler, Jason, Ghosh, Monalisa, Popplewell, Leslie, Chavez, Julio C., Bachy, Emmanuel, Kato, Koji, Harigae, Hideo, Kersten, Marie Jos, Andreadis, Charalambos, Riedell, Peter A., Ho, P. Joy, Prez-Simn, Jos Antonio, Chen, Andy I., Nastoupil, Loretta J., von Tresckow, Bastian, Ferreri, Andrs Jos Mara, Teshima, Takanori, Patten, Piers E. M., McGuirk, Joseph P., Petzer, Andreas L., Offner, Fritz, Viardot, Andreas, Zinzani, Pier Luigi, Malladi, Ram, Zia, Aiesha, Awasthi, Rakesh, Masood, Aisha, Anak, Oezlem, Schuster, Stephen J., Thieblemont, Catherine

Issue&Volume: 2021-12-17

Abstract: 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 phase2 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 29March 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 8weeks 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.

DOI: 10.1038/s41591-021-01622-0

Source: https://www.nature.com/articles/s41591-021-01622-0

Nature Medicine：《自然—医学》，创刊于1995年。隶属于施普林格·自然出版集团，最新IF：87.241
官方网址：https://www.nature.com/nm/
投稿链接：https://mts-nmed.nature.com/cgi-bin/main.plex


本期文章：《自然—医学》：Online/在线发表

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