The U.S Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with relapsed/refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.
MZL is a usually indolent mature B-cell lymphoma, arising from the marginal zone of lymphoid tissues. It is characterized by the presence of small to medium sized atypical lymphocytes. It comprises three entities, according to the anatomic sites involved: extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, which affects extranodal sites (most often stomach, lung, skin, and ocular adnexa); nodal marginal zone B-cell lymphoma, which affects lymph nodes without evidence of extranodal disease; and splenic marginal zone B-cell lymphoma, which affects the spleen and splenic hilar lymph nodes, bone marrow, and often the peripheral blood.
Liso-cel is a CD19-directed chimeric antigen receptor (CAR) T cell therapy that is administered as a one-time infusion. The therapy is made from the patient’s own T cells, which are collected and genetically reengineered into CAR T cells. Liso-cel is currently approved by the FDA for the treatment of relapsed/refractory large B-cell lymphoma, chronic lymphocytic leukemia or small lymphocytic leukemia, follicular lymphoma, and mantle cell lymphoma.
The approval is based on results from the MZL cohort in the TRANSCEND FL (NCT04245839) clinical trial. This was an open-label, multicenter, multi-cohort, single-arm study evaluating the safety and efficacy of liso-cel in patients with follicular lymphoma or MZL. The overall response rate of patients with MZL treated with liso-cel was 95.5% and the complete response rate was 62.1%. The median duration of response was not reached, with 90.1% of responders remaining in response at 24 months.
The safety profile of liso-cel was consistent with prior reports from trials in other indications. In the MZL cohort, any grade cytokine release syndrome occurred in 76% of patients, leading to BOXED WARNINGS for cytokine release syndrome, neurologic toxicities, and secondary hematological malignancies. Common nervous system disorders included headache, tremor, encephalopathy, dizziness, and aphasia.
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