Saturday, June 22, 2024

Follicular Lymphoma Treatment Advances with FDA Approval of Lisocabtagene Maraleucel

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Lymphoma treatment gains boost as FDA grants accelerated approval to lisocabtagene maraleucel (Breyanzi) by Juno Therapeutics for adults with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. This approval is significant for patients with this type of lymphoma, providing a new therapeutic option for those who have not responded to previous treatments.

Detailed prescribing information for Breyanzi will be available to healthcare providers and patients to ensure proper administration and management of the therapy. The efficacy of lisocabtagene maraleucel was evaluated in the TRANSCEND-follicular lymphoma (NCT04245839) trial, a Phase 2, open-label, multicenter, single-arm study.

This trial included adults with relapsed or refractory follicular lymphoma who had previously received two or more lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent. Eligibility criteria required patients to have adequate bone marrow function to receive lymphodepletion chemotherapy and an Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less.

TRANSCEND-FL Trial Shows High Efficacy of Lisocabtagene Maraleucel for Follicular Lymphoma

Patients in the TRANSCEND-FL trial underwent apheresis and could receive bridging therapy to control their disease before lymphodepletion and the subsequent administration of lisocabtagene maraleucel. The lymphodepletion chemotherapy regimen consisted of fludarabine (30 mg/m²/day) and cyclophosphamide (300 mg/m²/day) administered concurrently for three days. Following this, patients received a single dose of lisocabtagene maraleucel between two to seven days after completing the chemotherapy.

The primary efficacy population comprised 94 patients who had positron emission tomography (PET)-positive disease at baseline or after bridging therapy, received the intended dose range of lisocabtagene maraleucel, and had at least nine months of follow-up from the first response. The main efficacy outcomes measured were the overall response rate (ORR) and duration of response (DOR). The ORR, defined as the percentage of patients achieving either a complete response or a partial response, was 95.7% (95% CI: 89.5, 98.8). After a median follow-up of 16.8 months (95% CI: 16.3, 17.0), the median DOR was not reached (95% CI: 18.04, NR), indicating a potentially long-lasting response among the study participants.

Follicular Lymphoma

FDA Approves Lisocabtagene Maraleucel with REMS for Follicular Lymphoma Amid Adverse Reaction Concerns

The most common non-laboratory adverse reactions, occurring in 20% or more of patients, included cytokine release syndrome (CRS), headache, musculoskeletal pain, fatigue, constipation, and fever. Due to the risk of fatal or life-threatening CRS and neurologic toxicities, the FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy (REMS). The recommended dose of lisocabtagene maraleucel is between 90 to 110 million CAR-positive viable T cells, with a balanced ratio of CD4 and CD8 components. This precise dosing is essential for maximizing efficacy while managing potential side effects.

The accelerated approval of lisocabtagene maraleucel represents a promising advancement for patients with relapsed or refractory follicular lymphoma, offering a new therapeutic option after multiple lines of therapy have failed. The TRANSCEND-follicular lymphoma trial’s positive outcomes underscore the potential of this CAR T-cell therapy to provide significant and durable responses, addressing a critical need in the treatment landscape for this patient population. As further data becomes available, ongoing monitoring and research will continue to refine and enhance the use of this therapy in clinical practice.

 

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Resource: Food and Drug Administration, May 15, 2024

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