Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update

医学 四分位间距 滤泡性淋巴瘤 内科学 细胞因子释放综合征 胃肠病学 CD8型 耐火材料(行星科学) 临床研究阶段 肿瘤科 临床试验 淋巴瘤 免疫学 免疫疗法 抗原 癌症 嵌合抗原受体 生物 天体生物学
作者
Martin Dreyling,Nathan Fowler,Michael Dickinson,Joaquín Martínez‐López,Arne Kolstad,Jason Butler,Monalisa Ghosh,Leslie Popplewell,Julio C. Chávez,Emmanuel Bachy,Koji Kato,Hideo Harigae,Marie José Kersten,Charalambos Andreadis,Peter A. Riedell,P. Joy Ho,Jose Antonio Pérez‐Simón,Andy I. Chen,Loretta J. Nastoupil,Bastian von Tresckow,Andrés J.M. Ferreri,Takanori Teshima,Piers Patten,Joseph P. McGuirk,Andreas Petzer,Fritz Offner,Andreas Viardot,Pier Luigi Zinzani,Ram Malladi,Inès Paule,Aiesha Zia,Rakesh Awasthi,Xia Han,Davide Germano,Darragh O’Donovan,Roberto Ramos,Harald J. Maier,Aisha Masood,Catherine Thiéblemont,Stephen J. Schuster
出处
期刊:Blood [Elsevier BV]
卷期号:143 (17): 1713-1725 被引量:20
标识
DOI:10.1182/blood.2023021567
摘要

Abstract Tisagenlecleucel is approved for adults with relapsed/refractory (r/r) follicular lymphoma (FL) in the third- or later-line setting. The primary analysis (median follow-up, 17 months) of the phase 2 ELARA trial reported high response rates and excellent safety profile in patients with extensively pretreated r/r FL. Here, we report longer-term efficacy, safety, pharmacokinetic, and exploratory biomarker analyses after median follow-up of 29 months (interquartile range, 22.2-37.7). As of 29 March 2022, 97 patients with r/r FL (grades 1-3A) received tisagenlecleucel infusion (0.6 × 108-6 × 108 chimeric antigen receptor–positive viable T cells). Bridging chemotherapy was allowed. Baseline clinical factors, tumor microenvironment, blood soluble factors, and circulating blood cells were correlated with clinical response. Cellular kinetics were assessed by quantitative polymerase chain reaction. Median progression-free survival (PFS), duration of response (DOR), and overall survival (OS) were not reached. Estimated 24-month PFS, DOR, and OS rates in all patients were 57.4% (95% confidence interval [CI], 46.2-67), 66.4% (95% CI, 54.3-76), and 87.7% (95% CI, 78.3-93.2), respectively. Complete response rate and overall response rate were 68.1% (95% CI, 57.7-77.3) and 86.2% (95% CI, 77.5-92.4), respectively. No new safety signals or treatment-related deaths were reported. Low levels of tumor-infiltrating LAG3+CD3+ exhausted T cells and higher baseline levels of naïve CD8+ T cells were associated with improved outcomes. Tisagenlecleucel continued to demonstrate highly durable efficacy and a favorable safety profile in this extended follow-up of 29 months in patients with r/r FL enrolled in ELARA. This trial was registered at www.clinicaltrials.gov as #NCT03568461.
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