B07 | Long-term Clinical Outcomes With Tisagenlecleucel in High-risk Relapsed/refractory Follicular Lymphoma: 4-year Follow-up From the Phase 2 Elara Study
Year: 2025
Type: article
Abstract: Background: Treatment approach for relapsed/refractory follicular lymphoma (r/r FL) depends on previous treatments and patients’ characteristics. Tisagenlecleucel is a Chimeric Antigen Receptor T-cell therapy (CAR-T) approved for adults with r/r FL after at least two prior lines of systemic therapy. We present 4-year follow-up results on efficacy, safety, and pharmacokinetics of tisagenlecleucel treatment from phase 2 ELARA trial [1]. Methods: Patients with r/r FL (grades 1–3A), who had received at least two prior systemic therapies (including an anti-CD20 monoclonal antibody and alkylating agent), were treated with a single infusion of tisagenlecleucel (0.6–6×10⁸ CAR-positive viable T cells). Bridging therapy was allowed. Progression-free survival (PFS) and overall survival (OS) were correlated to baseline clinical characteristics and levels of circulating naïve T cells. Results: By March 27, 2024, 97 patients had received treatment, and 94 were evaluated for efficacy, with a median follow-up of 53 months (range: 46–62 months). At baseline, high-risk subgroups were identified: 66.0% had bulky disease and 64.9% experienced disease progression within two years of initial therapy (POD24). A high Follicular Lymphoma International Prognostic Index (FLIPI ≥3) was observed in 60.6% of patients, while 21.3% had a high tumor burden. The median PFS across all patients was 53.3 months (95% CI: 18.2–not estimable). At 48 months, the PFS was 50.2% in the overall population and 66.1% in patients who achieved the best overall response. In high-risk subgroups, 48-month PFS was 45.5% in POD24 group, 45.5% for high FLIPI, 45.2% in participants with bulky disease and 52.8% for double refractory. At 48 months, the OS rate among efficacy-evaluable patients was 79.3%; while the median OS was not reached. The 48-month OS rates were 80.8% for POD24, 73.2% for those with high FLIPI, 73.0% for patients with bulky disease, 83.7% for double refractory and 65.5% for those with high tumor burden. No new safety signals have been reported since the last data cut. Six patients (6.2%) developed second primary malignancies. Conclusions: Four-year follow-up from the ELARA study demonstrates robust and durable responses with tisagenlecleucel and a favorable safety profile. Baseline high-risk disease characteristics are not associated with reduced efficacy following tisagenlecleucel infusion. 1. C.Thieblemont, et al. Blood 2024; 144 (Suppl.1): 3034. ©ASH (2024) Reused with permission.
Authors: P.L. Zinzani, C. Thieblemont, M. Dreyling, M.J. Dickinson, J. Martínez-Lopez, A. Kolstad, J. Butler, M. Ghosh, L.L. Popplewell, J.C. Chavez, E. Bachy, K. Kato, H. Harigae, M.J. Kersten, C. Andreadis, P.A. Riedell, P.J. Ho, J.A. Pérez-Simón, A. Chen, L. Nastoupil, B. Von Tresckow, A.J.M. Ferreri, T. Teshima, P.E.M. Patten, J.P. Mcguirk, F. Offner, A. Viardot, R. Malladi, A. Zia, R. Awasthi, D. Germano, R.J. Ramos, P. Hsu, S.J. Schuster, N.H. Fowler
Institutions: Istituto di Ematologia di Bologna, University of Bologna, Hôpital Saint-Louis, Ludwig-Maximilians-Universität München, The Royal Melbourne Hospital, The University of Melbourne, Peter MacCallum Cancer Centre, Hospital Universitario 12 De Octubre, Centro de Investigación Biomédica en Red, Oslo University Hospital, University of Michigan, City Of Hope National Medical Center, City of Hope, Moffitt Cancer Center, Lyon 1 Université, Hospices Civils de Lyon, Kyushu University Hospital, Tohoku University, Amsterdam University Medical Centers, Cancer Center Amsterdam, University of Amsterdam, University of California, San Francisco, UCSF Helen Diller Family Comprehensive Cancer Center, University of Chicago, The University of Sydney, Royal Prince Alfred Hospital, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío, Universidad de Sevilla, Oregon Health & Science University, The University of Texas MD Anderson Cancer Center, University of Cologne, University Hospital Cologne, University of Duisburg-Essen, IRCCS Ospedale San Raffaele, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele, Hokkaido University, King's College London, University of Kansas Medical Center, Ghent University Hospital, University Hospital Ulm, Cambridge University Hospitals NHS Foundation Trust, Novartis (Switzerland), Abramson Cancer Center, University of Pennsylvania
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7093122161
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