Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed CAR T cell therapy approved for the treatment of relapsed/refractory large B-cell lymphoma (LBCL). We present a multicenter retrospective study evaluating safety, efficacy, and resource utilization 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 infused patients, the median age was 71 years (35% ≥75 years), 68% had a Charlson Comorbidity score ≥3, and 10% had secondary CNS involvement. Median number of prior therapies was 3, and due to comorbidities, 33% would have been ineligible for the TRANSCEND study. Bridging therapy was used in 60% (43% received polatuzumab-based treatment). Any Grade CRS occurred in 49% (3% Grade ≥3) with any Grade ICANS 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 were 55% and 68%, respectively. A normal lactate dehydrogenase pre-lymphodepletion was associated with improved PFS and OS. These analyses confirm similar efficacy and safety of commercial liso-cel compared to 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.

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http://dx.doi.org/10.1182/bloodadvances.2024014164DOI Listing

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Article Synopsis
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  • The successful implementation of outpatient monitoring programs for liso-cel requires collaboration among nurses, advanced practice providers (APPs), and other stakeholders, supported by thorough training and flexible processes.
  • Key features for effective outpatient monitoring include same-day discharge after infusion, ongoing patient availability for follow-up, and a coordinated approach to manage adverse events across different facilities.
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