Dr Dahiya on the FDA Approval of Liso-Cel for Relapsed/Refractory Follicular Lymphoma

Saurabh Dahiya, MD, FACP, associate professor, medicine (blood and marrow transplantation and cellular therapy), Stanford University School of Medicine, clinical director, Cancer Cell Therapy, Stanford BMT and Cell Therapy Division, discusses the significance of the FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) for patients with relapsed/refractory follicular lymphoma (FL).

On May 15, 2024, the FDA granted accelerated approval to liso-cel for the treatment of patients with relapsed/refractory FL who have received at least 2 prior lines of systemic therapy. This regulatory decision was based on findings from the single-arm, phase 2 TRANSCEND-FL trial (NCT04245839), in which liso-cel generated an overall response rate of 95.7% (95% CI, 89.5%-98.8%) in the population of patients with relapsed/refractory FL who had received at least 2 prior lines of systemic therapy, including an alkylating agent and an anti-CD20 antibody. After a median follow-up of 16.8 months (95% CI, 16.3-17.0), the median duration of response was not yet reached (NR; 95% CI, 18.04-NR).

In TRANSCEND-FL, patients received a single dose of liso-cel 2 to 7 days after completing lymphodepletion. The recommended dose of liso-cel is 90 x 10⁶ to 110 x 10⁶ CAR-positive viable T cells.

The most common nonlaboratory adverse effects observed in the study included cytokine release syndrome (CRS), headache, fatigue, musculoskeletal pain, fever, and constipation. Notably, the FDA approved liso-cel with a Risk Evaluation and Mitigation Strategy because of its associated risk of life-threatening or fatal neurologic toxicities and CRS.

Liso-cel is the third CAR T-cell therapy to receive FDA approval for patients with relapsed/refractory FL, Dahiya says. Liso-cel is an autologous, CD19-directed CAR T-cell therapy containing a 1:1 ratio of CD8-positive and CD4-positive CAR T cells, Dahiya explains. Liso-cel was previously shown to elicit deep and durable responses in patients with relapsed/refractory large B-cell lymphoma (LBCL), Dahiya notes. This regulatory decision confirms the agent’s efficacy in relapsed/refractory FL as well as LBCL, Dahiya concludes.