Data from a phase II study suggest that Lisocabtagene maraleucel (liso-cel) can be administered safely in the community setting for patients with relapsed or refractory large B-cell lymphoma. These findings were presented at the ASH annual meeting and exposition in 2022.
Liso-cel is a CD-19-directed CAR-T cell therapy usually given in an inpt setting due to adverse event (AEs) management issues. Linhares et al. have evaluated the efficacy and safety of liso-cel infusion and output monitoring in community settings. Adults with Relapsed or Refractory (R/R) Large B-Cell Lymphoma (LBCL) after ≥ 2 lines of therapy were enrolled at community sites and received CAR-T cell cells at a target dose of 100 × 106. The study’s primary endpoint was grade ≥ 3 cytokine release syndrome (CRS), neurological events, prolonged cytopenias and infections. The secondary endpoints were safety, ORR, CR rate, duration of response and PFS.
The treatment showed clinical efficacy with a manageable safety profile in outpatient settings. Most common AEs included neutropenia (68%), leukopenia (44%), CRS (39%), thrombocytopenia (35%), anaemia (33%), and fatigue (30%). Notably, 24% of outpatients were never hospitalised after CAR-T cell treatment, and 31% were hospitalised after 4 or more days of liso-cel infusion.
These findings demonstrate the clinical efficacy and safety of liso-cel in outpatients and thus pave the way for using this treatment strategy more cost-effectively.
Linhares Y, et al. Abstract 4673. Presented at: ASH Annual Meeting and Exposition; Dec. 10-13, 2022; New Orleans.