Real-world outcomes for lisocabtagene maraleucel in patients with relapsed or refractory large B-cell lymphoma.

This study assessed real-world effectiveness and safety of lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including those with high-risk disease, secondary central nervous system (sCNS) involvement, comorbidities, and poor fitness, using data in the Center for International Blood and Marrow Transplant Research Registry from 5 February 2021 to 4 February 2025. Eligible patients (N = 1116) received liso-cel and had ≥1 effectiveness and safety assessment after infusion, including 195 in the second-line setting, 71 with sCNS, and 257 with transformed LBCL. Median age was 71.1 years (range, 21.5-91.2), with 72.3% aged ≥65 years. Within the overall population, 6.6% had an Eastern Cooperative Oncology Group performance status of ≥2, 53.4% had ≥1 comorbidity, and the median number of previous lines of therapy was 3 (range, 1-16). Median study follow-up was 12.6 months (95% confidence interval [CI], 12.5-12.8). Among effectiveness-evaluable patients (n = 1109), objective response rate was 81.2% and complete response rate was 71.3%. Duration of response, progression-free survival, and overall survival rates at 12 months were 60.2% (95% CI, 56.4-63.9), 51.2% (95% CI, 48.0-54.4), and 67.6% (95% CI, 64.5-70.6), respectively. Cytokine release syndrome was reported in 51.0% of patients, with grade ≥3 events in 2.5%. Immune effector cell-associated neurotoxicity syndrome was reported in 26.6% of patients, with grade ≥3 events in 9.2%. The 12-month nonrelapse mortality rate was 6.1% (95% CI, 4.6-7.8). These real-world data reinforce the effectiveness and safety of liso-cel in this broad population of patients with R/R LBCL, including younger patients and those with high-risk disease features.