Lisocabtagene Maraleucel Therapy for Mantle Cell Lymphoma Receives FDA Approval
Introduction
On May 30th, the U.S. Food and Drug Administration (FDA) approved the use of lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory mantle cell lymphoma. This chimeric antigen receptor (CAR) T-cell therapy is intended for patients who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
Efficacy
The efficacy of the therapy was evaluated in the mantle cell lymphoma cohort of TRANSCEND NHL 001, an open-label, multicenter, single-arm trial in adult patients with relapsed or refractory mantle cell lymphoma. Patients received a single dose of lisocabtagene maraleucel 2 to 7 days following the completion of lymphodepleting chemotherapy.
Overall Response Rate
The main efficacy outcome measure was overall response rate, defined as the percentage of patients with best overall response of either complete response or partial response after lisocabtagene maraleucel infusion as determined by an independent review committee using 2014 Lugano classification. The overall response rate was 85. 3% (95% confidence interval [CI] = 74. 6%–92. 7%).
Complete Response Rate
The complete response rate was 67. 6% (95% CI = 55. 2%–78. 5%).
Duration of Response
After a median follow-up of 22. 2 months (95% CI = 16. 7–22. 8 months), the median duration of response was 13. 3 months (95% CI = 6. 0–23. 3 months).
Adverse Reactions
The most common nonlaboratory adverse reactions (occurring in ≥ 20% of patients who received lisocabtagene maraleucel) were cytokine-release syndrome, fatigue, musculoskeletal pain, encephalopathy, edema, headache, and decreased appetite. The FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy due to the risk of fatal or life-threatening cytokine-release syndrome and neurologic toxicities.
Recommended Dosage
The recommended lisocabtagene maraleucel dose is 90 to 110 × 106 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components.
Conclusion
This approval is significant for adult patients with relapsed or refractory mantle cell lymphoma who have exhausted other treatment options. Lisocabtagene maraleucel offers a new potential option for those patients and has shown promising results in the clinical trials conducted. It is important to note that this therapy comes with risks, but the FDA’s Risk Evaluation and Mitigation Strategy will help to ensure its safe usage.
Originally Post From https://ascopost.com/issues/june-10-2024/fda-approves-lisocabtagene-maraleucel-for-relapsed-or-refractory-mantle-cell-lymphoma/
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