1. The median event-free survival in the liso cell group was significantly greater than in the standard treatment group (10.1 months vs. 2.3 months).
2. Neutropenia of grade 3 or worse was more common in the liso cell group than in the control group.
Evidence Rating Level: 1 (Excellent)
Study overview: Primary refractory large B-cell lymphoma (LBCL) refers to disease relapse within 12 months of first-line immunochemotherapy treatment. Currently, results with second-line approaches are poor and there is a need for more effective therapies. CD-19-targeted chimeric antigen receptor (CAR) T cell therapy, such as lisocabtagene maraleucel (liso cell), may help improve LBCL outcomes, although evidence for its effectiveness is lacking. This randomized controlled trial was designed to compare the safety and efficacy of liso cell with the standard of care for the treatment of refractory large B cell lymphoma. The primary outcome measure was event-free survival, while the main secondary outcomes were complete response rate and overall survival. According to study results, the liso cell groups reported significantly increased event-free survival compared to the standard of care group. Similar findings were seen with regard to overall and progression-free survival. This study was augmented by a diverse sample of patients from different countries who were followed longitudinally for different clinical markers.
Click to read the study in The Lancet
Relevant literature: second-line tisagenlecleucel or standard of care in aggressive B-cell lymphoma
in-depth [randomized-controlled trial]† From October 23, 2018 to December 8, 2020, 232 patients were assessed for eligibility at 47 locations in the US, Europe and Japan. Included were patients aged 18-75 years with an Eastern Cooperative Oncology Group (ECOG) performance status score ≥1 and PET-confirmed LBCL. A total of 184 patients (92 each in the liso cell and the standard-of-care group) were included in the analysis. The primary outcome of event-free survival at 6 months was significantly better in the liso-cell group (10.1 months, 95% confidence interval [CI] 6.1-not reached) vs. standard 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-cell group, the overall related adverse events between both groups were comparable (48% each). In addition, one treatment-related death occurred, which was in the SOC group. Findings from this study suggest the use of liso-cell in patients with refractory LBCL.
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