1. The median event-free survival in the liso-cel group was significantly higher than in the standard treatment group (10.1 months versus 2.3 months).
2. Grade 3 or worse neutropenia was more common in the liso-cel group than in the control group.
Level of evidence assessment: 1 (Excellent)
Summary of the study: Primary refractory large B-cell lymphoma (LBCL) refers to disease relapse within 12 months of first-line immunochemotherapy treatment. Currently, results from second-line approaches are poor and there is a need for more effective therapies. CD-19 chimeric antigen receptor (CAR)-directed T cell therapy, such as lisocabtagen maraleucel (liso-cel), may help improve LBCL outcomes, although evidence surrounding its effectiveness is lacking. This randomized controlled trial aimed to compare the safety and effectiveness of liso-cel versus standard therapy for the treatment of refractory large B-cell lymphoma. The primary outcome was event-free survival, while the primary secondary outcomes included complete response rate and overall survival. According to the study results, the liso-cel groups reported significantly increased event-free survival compared to the standard care group. Similar results were observed for overall and progression-free survival. This study was strengthened by a diverse sample of patients from different countries who were followed longitudinally for various clinical markers.
In depth [randomized-controlled trial]: From October 23, 2018 to December 8, 2020, 232 patients were assessed for eligibility at 47 sites in the United States, Europe, and Japan. Included were patients aged 18 to 75 years with an Eastern Cooperative Oncology Group (ECOG) performance status score ≥ 1 and a PET-confirmed LBCL. A total of 184 patients (92 each in the liso-cel group and the standard of care group) were included in the analysis. The primary endpoint of event-free survival at 6 months was significantly better in the liso-cel group (10.1 months, 95% confidence interval [CI] 6.1-not achieved) compared to standard of care [SOC] group (2.3 months, 95% CI 2.2-4.3; stratified hazard ratio [sHR] 0.35, p<0.0001). Although common adverse events such as neutropenia (80% vs 51%), anemia (49% vs 49%) and thrombocytopenia (49% vs 64%) were more frequent in the liso-cel group, a Overall serious treatment - related adverse events between the two groups were comparable (48% each). In addition, one treatment-related death occurred in the SOC group. The results of this study suggest the use of liso-cel in patients with refractory LBCL.
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