Dr Kenderian on the FDA Approval of Liso-Cel in Relapsed/Refractory CLL/SLL

Saad J. Kenderian, MB, CHB, consultant, Division of Hematology, Department of Internal Medicine, Department of Immunology, Department of Molecular Medicine, assistant professor, oncology, immunology, medicine, Mayo Clinic, discusses the significance of the FDA approval of lisocabtagene maraleucel (liso-cel; Breyanzi) for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

On March 14, 2024, the FDA granted accelerated approval to liso-cel for the treatment of adult patients with relapsed/refractory CLL or SLL who have been treated with 2 or more prior lines of therapy, including a BCL-2 inhibitor and a BTK inhibitor. This regulatory decision was supported by findings from the phase 1/2 TRANSCEND CLL 004 trial (NCT03331198), in which patients who received liso-cel achieved an objective response rate (ORR) of 45% (95% CI, 32.3%-57.5%), including a complete response (CR) rate of 20% (95% CI, 11.1%-31.8%). The median duration of response (DOR) in the entire population was 35.3 months (95% CI, 12.4-not yet reached [NR]), and the median DOR in the patients who achieved a CR was NR (95% CI, 15-NR). Moreover, the median time to first response was 1.1 months (range, 0.8-17.4), and the median time to first CR was 3.0 months (range, 1.1-17.9).

The ORR observed with liso-cel in patients with CLL/SLL is notable, Kenderian says, emphasizing that 20% of patients who receive this therapy experienced deep CRs and may be cured of their disease. Some of the first patients with CLL to receive CAR T-cell therapy remain in remission approximately 10 years after CAR T-cell infusion, Kenderian adds. Furthermore, some patients with CLL/SLL who received liso-cel in the TRANSCEND CLL 004 trial remain in remission 4 or more years after liso-cel infusion, Kenderian notes. Overall, the FDA approval of liso-cel in CLL/SLL allows more patients who progressed on other available therapies the opportunity to receive another effective option, Kenderian concludes.