Dr Kenderian on the Efficacy of Liso-Cel in R/R CLL/SLL


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Saad J. Kenderian, MB, CHB, consultant, discusses the safety and efficacy findings derived from the phase 1/2 TRANSCEND CLL 004 study in 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 safety and efficacy findings derived from the phase 1/2 TRANSCEND CLL 004 study (NCT03331198) evaluating lisocabtagene maraleucel (liso-cel; Breyanzi) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

In March 2024, findings from the study supported the FDA approval of liso-celfor the treatment of adult patients with relapsed or refractory CLL or SLL who have previously received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

Data showed that liso-cel (n = 65) elicited a complete response (CR) rate of 20% (95% CI, 11.1%-31.8%), alongside a noteworthy achievement of minimal residual disease negativity, Kenderian reports. While acknowledging potential avenues for enhancement in CAR T-cell therapy for CLL/SLL, the ability of liso-cel to induce CR in 1 in 5 heavily pretreated patients lacking effective options underscores its significant clinical impact, Kenderian states. Notably, at the data cutoff date, patients who achieved the CR experienced a median duration of response that was not yet reached (NR; 95% CI, 15 months–NR).

Regarding safety, liso-cel exhibited low rates of toxicities, particularly cytokine release syndrome (CRS), attributed partly to its balanced CD4 and CD8 CAR T cell ratio, Kenderian states. Toxicity profiles observed in TRANSCEND CLL 004 align with prior trials of liso-cel; however, CRS and neurotoxicity rates were notably subdued, he reports. This trend is particularly promising for diseases prevalent in older, heavily pretreated populations, Kenderian expands. Most CRS events were of grade 1/2 severity, with 9% escalating to grade 3/4. Similarly, neurotoxicity predominantly manifested as grade 1/2 events. These findings collectively suggest a favorable safety profile for liso-cel, reinforcing its potential as a therapeutic option for patients with CLL whose disease is refractory to standard treatments, Kenderian concludes.

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