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

• DOI: 10.1182/blood.2023021567
• Publication Date: 2024-01-09T22:15:56Z
• Authors: Martin Dreyling; Nathan Hale Fowler; Michael Dickinson; Joaquin Martinez-...; Arne Kolstad; Jason Butler; Monalisa Ghosh; Leslie Popplewell; Julio C. Chavez; Emmanuel Bachy; Koji Kato; Hideo Harigae; Marie José Kersten; Charalambos Andre...; Peter A. Riedell; P. Joy Ho; José Antonio Pére...; Andy I. Chen; Loretta J. Nastoupil; Bastian von Tresckow; Andrés José María...; Takanori Teshima; Piers E. M. Patten; Joseph P. McGuirk; Andreas L. Petzer; Fritz Offner; Andreas Viardot; Pier Luigi Zinzani; Ram Malladi; Ines Paule; Aiesha Zia; Rakesh Awasthi; Xia Han; Davide Germano; Darragh O’Donovan; Roberto Ramos; Harald J. Maier; Aisha Masood; Catherine Thieble...; Stephen J. Schuster
• Keywords: Follicular lymphoma; Refractory (planetary science)

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 phase 2 ELARA trial reported high response rates and excellent safety profile patients extensively pretreated r/r FL. Here, we report longer-term efficacy, safety, pharmacokinetic, exploratory biomarker analyses after median follow-up 29 months (interquartile range, 22.2-37.7). As March 2022, 97 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 circulating cells were correlated response. Cellular kinetics assessed by quantitative polymerase chain reaction. Median progression-free survival (PFS), duration (DOR), overall (OS) not reached. Estimated 24-month PFS, DOR, OS all 57.4% (95% confidence interval [CI], 46.2-67), 66.4% CI, 54.3-76), 87.7% 78.3-93.2), respectively. Complete rate 68.1% 57.7-77.3) 86.2% 77.5-92.4), No new signals treatment-related deaths reported. Low levels tumor-infiltrating LAG3+CD3+ exhausted higher baseline naïve CD8+ associated improved outcomes. continued to demonstrate highly durable efficacy a favorable this extended enrolled ELARA. This registered at www.clinicaltrials.gov as #NCT03568461.