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The FDA has granted accelerated approval to lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy.1
The regulatory decision was supported by data from the phase 2 TRANSCEND-FL trial (NCT04245839), which showed that liso-cel (n = 94) elicited an overall response rate (ORR) of 95.7% (95% CI, 89.5%-98.8%). At a median follow-up of 16.8 months (95% CI, 16.3-17.0), patients experienced a median duration of response that was not reached (NR; 95% CI, 18.04-NR).
The open-label, multicenter, single-arm trial enrolled patients with relapsed or refractory follicular lymphoma who received 2 or more lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent. Patients also needed to have adequate bone marrow function to receive lymphodepleting chemotherapy, as well as an ECOG performance status of 0 or 1.
Patients were excluded if they had evidence or a history of composite diffuse large B-cell lymphoma and follicular lymphoma, or transformed follicular lymphoma; a WHO subclassification of duodenal-type follicular lymphoma; central nervous system–only involvement by malignancy; or prior CAR T-cell therapy or other genetically-modified cell therapy.2
After T cells were collected, patients underwent lymphodepletion consisting of fludarabine at 30 mg/m2 per day and cyclophosphamide at 300 mg/m2 per day for 3 days. Two to 7 days after the completion of lymphodepleting chemotherapy, patients then received liso-cel at a target dose of 100 x 106 CAR-positive T cells.
ORR served as the trial's primary end point. Secondary end points included complete response (CR) rate, DOR, progression-free survival (PFS), overall survival, and safety.
Data from TRANSCEND-FL presented at the 17th Annual International Conference on Malignant Lymphoma showed that in efficacy-evaluable patients with relapsed/refractory follicular lymphoma who were treated in the third line and beyond (n = 101), liso-cel generated an ORR of 97% (95% CI, 91.6%-99.4%; P <.0001). Furthermore, the CR rate was 94% (95% CI, 87.5%-97.8%; P <.0001). At 12 months, responses were ongoing in 81.9% of patients.3
At a median follow-up of 17.5 months, the median PFS was NR, and the 12-month PFS rate was 80.7%.
Regarding safety, the most common nonlaboratory adverse effects reported in at least 20% of patients included cytokine release syndrome, headache, musculoskeletal pain, fatigue, constipation, and fever.1
The recommended dose for liso-cel is 90 × 106 to 110 × 106 CAR-positive T cells with a 1:1 ratio of CD4 and CD8 components.