Lisocabtagene maraleucel approved for the treatment of adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least 2 other types of systemic treatment.
It is a CAR T-cell product is developed by using each patient’s own T cells.
The T cells are collected and genetically modified to comprise a new gene that facilitates targeting and elimination of lymphoma cells.
Once the cells are modified, they are then infused back into the individual.
An anti-CD19–targeted CAR T-cell therapy.
Tradename Breyanzi.
Phase 1 TRANSCEND NHL 001 trial, in which liso-cel resulted in an objective response rate of 73% and a complete response (CR) rate of 53%, with the time to first CR or partial response occurring at a median of 1 month.
The median duration of response had not yet been reached at a median follow-up of 12 months.
At 6 months, 60.4% of patients remained in response, while 54.7% continued to respond at 12 months.
The median progression-free survival with the CAR T-cell product was reported to be 6.8 months and 44% of patients remained free of disease progression.
The median OS with liso-cel was 21.1 months.
Patients were heavily pretreated, as they had received a median of 3 prior lines of therapy.
Thirty-five percent of patients underwent prior autologous or allogeneic hematopoietic stem cell transplant and 67% had disease that was refractory to chemotherapy.
44% of patients never achieved a CR with previous treatment.
Median progression free survival was similar between the overall diffuse LBCL population and those with double-hit lymphoma or transformed lymphoma from nonfollicular histologies.
The median PFS and OS for patients who achieved a CR was not reached, with 65.1% of patients progression free and 85.5% of patients alive at 12 months, respectively.
Lisocabtagene maraleucelas as a second line treatment in patients with relapsed/refractory large B cell lymphoma in whom HSCT was not intended have a higher rate of overall and complete responses, with durable responses in patient’s who had a complete response.
Incidences of severe cytokine release syndrome(CRS) and neurologic events were low with liso-cel.
Grade 3/4 CRS each were observed in only 1% of patients, and only 10% of participants experienced grade 3/4 neurologic effects.
Other toxicities include: hypersensitivity reactions, serious infections, low blood cell counts, and a weakened immune system.
Adverse effects typically present within the first 2 weeks of administration.