The New England Journal of Medicine<\/a>, Ruella et al found that a single infusion of the CD19-directed chimeric antigen receptor (CAR) T-cell therapy CTL019 (now called tisagenlecleucel) produced decade-long remissions in a subset of patients with relapsed or refractory B-cell non-Hodgkin lymphoma.<\/p>\nStudy Details<\/p>\n
A total of 38 patients (24 patients with large B-cell lymphoma and 14 with follicular lymphoma) were treated with tisagenlecleucel from January 2014 to September 2019, with a data cutoff of October 2025 for the long-term follow-up. The investigators assessed lymphoma-free survival, progression-free survival, overall survival, duration of response, late toxicities, immune reconstitution, and CAR T-cell persistence. Patients remaining in continuous complete remission for at least 5.5 years without additional therapy were classified as long-term responders.<\/p>\n
Key Findings<\/p>\n
At a median follow-up of 10.1 years (range = 7.9\u201311.5 years), no relapses had occurred beyond 5.4 years. Overall, 12 of 38 treated patients (31.6%) achieved a long-term response. At 10 years, lymphoma-free survival was 32% (95% confidence interval [CI] = 14%\u201351%) among patients with large B-cell lymphoma and 47% (95% CI = 20%\u201370%) among those with follicular lymphoma. Progression-free survival was 17% (95% CI = 5%\u201334%) and 29% (95% CI = 9%\u201352%), respectively, whereas overall survival was 17% (95% CI = 5%\u201334%) and 50% (95% CI = 23%\u201372%).<\/p>\n
Among responders, the estimated duration of response at 10 years was 54% (95% CI = 25%\u201377%) for those with large B-cell lymphoma and 60% (95% CI = 25%\u201383%) for those with follicular lymphoma. No relapses occurred beyond 5.4 years overall or beyond 2.7 years among patients with follicular lymphoma.<\/p>\n
Persistent grade 2 or 3 neutropenia occurred in two patients; no chronic anemia or thrombocytopenia was observed. Nine patients developed a second primary malignancy, corresponding to a 10-year cumulative incidence of 21% (95% CI = 8%\u201334%). No CAR T-cell\u2013related lymphomas were identified, and the cumulative incidence of nonrelapse-related mortality at 10 years was 18%.<\/p>\n
The investigators concluded: \u201cAmong patients with heavily pretreated B-cell non-Hodgkin lymphoma, a single infusion of tisagenlecleucel led to decade-long remissions (lymphoma-free survival) in approximately one-third of the patients with large B-cell lymphomas and in nearly one half of those with follicular lymphoma.\u201d<\/p>\n
Marco Ruella, MD, and Stephen J. Schuster, MD, of Perelman School of Medicine, the University of Pennsylvania, Philadelphia, are the corresponding authors for the New England Journal of Medicine article.<\/p>\n
DISCLOSURE: The study was funded by the Richard Berman Family Innovations Center in CLL and Lymphomas and others. For full disclosures of the study authors, visit nejm.org<\/a>.<\/p>\n
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