Durable response after tisagenlecleucel in adults with relapsed/refractory follicular lymphoma: ELARA trial update.
СтатьяПоддержка исследования: вне правительства СШАКлиническое исследование II фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Dreyling Martin, Fowler Nathan Hale, Dickinson Michael, Martinez-Lopez Joaquin, Kolstad Arne, Butler Jason, Ghosh Monalisa, Popplewell Leslie, Chavez Julio C, Bachy Emmanuel, Kato Koji, Harigae Hideo, Kersten Marie José, Andreadis Charalambos, Riedell Peter A, Ho P Joy, Pérez-Simón José Antonio, Chen Andy I, Nastoupil Loretta J, von Tresckow Bastian, María Ferreri Andrés José, Teshima Takanori, Patten Piers E M, McGuirk Joseph P, Petzer Andreas L, Offner Fritz, Viardot Andreas, Zinzani Pier Luigi, Malladi Ram, Paule Ines, Zia Aiesha, Awasthi Rakesh, Han Xia, Germano Davide, O'Donovan Darragh, Ramos Roberto, Maier Harald J, Masood Aisha, Thieblemont Catherine, Schuster Stephen J
Аннотация
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.