Safety data of lisocabtagene maraleucel supports its use in an outpatient setting

January 2023 Clinical practice Nalinee Pathak

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.

Adverse events

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.

Reference

Linhares Y, et al. Abstract 4673. Presented at: ASH Annual Meeting and Exposition; Dec. 10-13, 2022; New Orleans.

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