Lisocabtagene maraleucel for relapsed/refractory large B-cell lymphoma: a cell therapy consortium real-world analysis.

Abstract: Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed chimeric antigen receptor T-cell therapy approved for the treatment of relapsed/refractory large B-cell lymphoma. We present a multicenter retrospective study evaluating safety, efficacy, and resource use of liso-cel in the standard-of-care setting. Patients received commercial liso-cel at 7 US medical centers, and patient selection, toxicity management, and disease assessment followed institutional practices. Among 101 patients who received infusion, the median age was 71 years (35% aged ≥75 years), 68% had a Charlson comorbidity index score of ≥3, and 10% had secondary central nervous system involvement. Median number of prior therapies was 3; and because of comorbidities, 33% would have been ineligible for the TRANSCEND study. Bridging therapy was used in 60% (43% received polatuzumab-based treatment). Any-grade cytokine-release syndrome occurred in 49% (3% grade ≥3) with any-grade immune effector cell-associated neurotoxicity syndrome occurring in 26% (10% grade ≥3). The overall response rate (ORR) to bridging therapy was 45%, with 18% achieving a complete response (CR). Following liso-cel infusion, the day 90 ORR was 66% (60% CR); and with a median follow-up of 15.5 months, 12-month progression-free survival (PFS) and overall survival (OS) were 55% and 68%, respectively. A normal lactate dehydrogenase level before lymphodepletion was associated with improved PFS and OS. These analyses confirm similar efficacy and safety of commercial liso-cel compared with pivotal trial results. Notably, these outcomes were achieved in patients predominantly of advanced age and with significant comorbidities. Results also likely reflect advancements in patient selection, toxicity management, and the use of novel bridging strategies.