1. Median event-free survival in the liso-cel group was significantly greater than in the standard-of-care group (10.1 months vs. 2.3 months).

2. Grade 3 or worse neutropenia was more common among the liso-cel group than control.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Primary refractory large B-cell lymphoma (LBCL) refers to disease relapse within 12 months of first-line immunochemotherapy treatment. Currently, outcomes with second-line approaches have been poor and there is a need for more effective therapies. CD-19 directed chimeric antigen receptor (CAR) T-cell therapy, such as lisocabtagene 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 efficacy of liso-cel vs. standard-of-care therapy for treatment of refractory large B-cell lymphoma. The primary outcome was event-free survival while key secondary outcomes included complete response rate and overall survival. According to study results, the liso-cel groups reported significantly increased event-free survival compared to the standard-of-care group. Similar findings were seen with respect to 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.

Click to read the study in The Lancet

Relevant Reading: Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma

In-depth [randomized-controlled trial]: From Oct 23, 2018, and Dec 8, 2020, 232 patients were assessed for eligibility across 47 sites in the USA, 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. Altogether, 184 patients (92 each in liso-cel and 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-cel group (10.1 months, 95% confidence interval [CI] 6.1-not reached) vs. 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, overall serious treatment-related adverse events between both groups were comparable (48% each). Furthermore, one-treatment related death occurred which was in the SOC group. Findings from this study suggest the use of liso-cel in patients with refractory LBCL.

Image: PD

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