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CAR T-Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma
Investigators from the industry-sponsored, phase 3 ZUMA-7 trial previously reported that CD19-targeted chimeric antigen receptor (CAR) T-cell therapy with axicabtagene ciloleucel (axi-cel) showed superior event-free survival compared with standard of care high-dose immunochemotherapy followed by autologous stem cell transplantation (HDT-ASCT) in patients with relapsed/refractory large B-cell lymphoma (LBCL; NEJM JW Oncol Hematol Jan 6 2022 and N Engl J Med 2022; 386:640). The investigators now report a prespecified overall survival (OS) analysis at 5 years.
In brief, 359 adults with progression of LBCL during or within 12 months after first-line immunochemotherapy were randomized to receive either axi-cel or an investigator-selected standard platinum-based immunochemotherapy followed by HDT-ASCT in responding patients. Although crossover was not a component of this trial, 57% of patients with disease progression or lack of response to HDT-ASCT subsequently received an off-protocol cellular therapy (including axi-cel in 77.5% of them).
At a median follow-up of 47.2 months, the median OS was not reached for axi-cel versus 31.1 months with HDT-ASCT; 4-year OS was 54.6% versus 46.0%, respectively (hazard ratio for death, 0.73; P=0.03). The median progression-free survival (PFS) was also improved in the axi-cel arm (14.7 vs. 3.7 months), as was 4-year PFS (41.8% vs. 24.4%). No unexpected long-term safety signals were noted; CAR T-cell–related cytopenia and B-cell depletion recovered over time.
Long-term follow-up of the practice-changing ZUMA-7 trial now confirms a significant OS benefit with axi-cel in patients with LBCL that is primarily chemorefractory or progresses within 12 months after induction therapy, thus verifying axi-cel as a preferred approach in these poor-risk patients. Another commercially available CAR T-cell, lisocabtagene maraleucel, also outperformed HDT-ASCT (NEJM JW Oncol Hematol Apr 27 2023 and Blood 2023; 141:1675), although tisagenlecleucel did not, possibly related in part to study design and longer time to CAR T-cell manufacture (NEJM JW Oncol Hematol Jan 6 2022 and N Engl J Med 2022; 386; 629). Patients with LBCL relapse more than 12 months after induction therapy remain candidates for standard second-line immunochemotherapy and ASCT.
Westin JR et al.
Title: Survival with axicabtagene ciloleucel in large B-cell lymphoma.
Source: N Engl J Med 2023 Jul 13; [e-pub]. (Abstract/FREE Full Text)