On May 15, 2024, lisocabtagene maraleucel (Breyanzi) was granted accelerated approval for adults with relapsed or refractory follicular lymphoma with two or more prior lines of systemic therapy.1 The agent is a CD19-directed genetically modified autologous T-cell immunotherapy.
Supporting Efficacy Data
Approval was based on the multicenter TRANSCEND-FL trial (ClinicalTrials.gov identifier NCT04245839), in which 94 evaluable patients (out of 114 patients undergoing leukapheresis) with at least two prior lines of systemic therapy, received a single dose of lisocabtagene maraleucel 2 to 7 days after completing lymphodepleting chemotherapy.
Objective responses on independent review committee assessment were observed in 90 patients (95.7%), with a complete response in 69 (73.4%). The median duration of response was not reached.
How It Is Used
Lisocabtagene maraleucel must be administered at a Risk Evaluation and Mitigation Strategy (REMS)-certified health-care facility. The recommended dose is 90 to 110 × 106 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components.
OF NOTE
Lisocabtagene maraleucel has a boxed warning for cytokine-release syndrome, neurologic toxicity, and T-cell malignancies.Safety Profile
Among 107 patients in the TRANSCEND-FL safety population, the most common grade ≥ 3 adverse events included infection (5%) and cytokine-release syndrome (1%). The most common grade 3 or 4 laboratory abnormalities were hematologic adverse events, including decreased lymphocytes (94%), neutrophils (79%), white blood cells (74%), and hemoglobin (17%). Serious adverse events occurred in 26% of patients, most commonly (> 2%) cytokine-release syndrome, aphasia, febrile neutropenia, fever, and tremor.
Lisocabtagene maraleucel has a boxed warning for cytokine-release syndrome, neurologic toxicity, and T-cell malignancies. The agent is available only through a restricted program called BREYANZI REMS. It should not be used in patients with primary central nervous system lymphoma.
REFERENCE
1. Breyanzi (lisocabtagene maraleucel) suspension for intravenous infusion, prescribing information, Juno Therapeutics, Inc, a Bristol-Myers Squibb Company, 2024. Available at https://www.breyanzihcp.com. Accessed May 29, 2024.
