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.
Approved based on the TRANSCEND NHL 001 trial for the treatment of relapsed or refractory large cell lymphoma after two or more lines of systemic therapy.
Also approved for use in patients with CLL or small lymphocytic leukemia after two prior treatments, including a BTK inhibitor and a BLC2 inhibitor based on the results of TRANSCEND CLL 004 trial.
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.