Lisocabtagene maraleucel (liso-cel) treatment of follicular lymphoma (FL) after at least 2 prior lines of therapy resulted in deep and durable remissions, according to the primary analysis of the TRANSCEND FL study. The complete response (CR) rate was high at 94% and the median duration of response was not yet reached, according to data presented at the SOHO 2023 Annual Meeting.

 The open-label, multicenter phase 2 TRANSCEND FL trial ( identifier: NCT04245839) treated 130 patients with FL who received 2 or more prior lines of therapy with a single infusion of liso-cel. All patients received fludarabine plus cyclophosphamide lymphodepletion prior to their liso-cel infusion. The primary endpoint was objective response rate (ORR). Secondary endpoints included the CR rate, progression-free survival (PFS), overall survival (OS), and safety.

This report focused on the 107 patients who received liso-cel as third-line therapy. The median age of this cohort was 62 and 62% of patients were male. There were 67% of patients with grade 1/2 disease and 23% with grade 3A and the Ann Arbor stage at screening was I/II in 10% of patients and stage III/IV in 52%.

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The median number of prior lines of therapy was 3 (range, 2-10) and 31% of patients had previously undergone a hematopoietic stem cell transplant. A total of 67% of patients were refractory to their last systemic therapy and 64% were double-refractory.

The ORR was 97%, with 94% of patients achieving a CR, 3% a partial response,  and 1% stable disease. The 12-month duration of response was 81.9% with a median follow-up of 16.6 months. The 12-month PFS was 80.7%, and the median was not yet reached, during a median follow-up of 17.5 months.

The most common grade 3 or higher treatment-emergent adverse events was neutropenia (58%), lymphopenia (13%), leukopenia (12%), anemia (10%), and thrombocytopenia (10%). There were 58% of patients who developed cytokine release syndrome of any grade, with 1% grade 3 or higher. Liso-cel persisted among 45% of patients at 12 months and 18 months.

“Liso-cel demonstrated clinically meaningful benefit in patients with relapsed/refractory FL, supporting liso-cel as a potential new treatment option for these patients,” the presenter concluded.

Disclosures: This study was supported by Celgene. Please see the original reference for a full list of disclosures.

Nastoupil LJ, Dahiya S, Palomba ML, et al. TRANSCEND FL: Phase 2 study results of lisocabtagene maraleucel in patients with relapsed or refractory follicular lymphoma. Presented at: the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO); September 6-9, 2023. IBCL-098.