Dr Brander on Findings From the TRANSCEND CLL 004 Trial in Relapsed/Refractory CLL/SLL

Danielle M. Brander, MD, hematologic oncologist, hematologist, assistant professor of medicine, Hematologic Malignancies and Cellular Therapy, member, the Duke Cancer Institute, Duke Health, discusses the primary analysis of the phase 1/2 TRANSCEND CLL 004 trial (NCT03331198) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The single-arm, multicenter study evaluated the use of the CAR T-cell therapy lisocabtagene maraleucel (Breyanzi; liso-cel) in patients with CLL/SLL who have progressed on a BTK inhibitor as well as on a venetoclax (Venclexta)–based regimen. Findings from 2 dose levels in this study which have been previously presented, Brander notes. The primary analysis of this study was presented at the 2023 iwCLL Annual Meeting, Brander states, adding that a total of 49 patients who had both exposure to a BTK inhibitor and to venetoclax were evaluated. The primary end point was rate of complete response (CR) and CR with incomplete marrow count recovery (CRi), Brander says. The rate of CR/CRi was 18% (95% CI, 9%-32%; P = .0006), Brander adds.

A key secondary end point evaluated in this study was the rate of undetectable minimal residual disease (MRD) in the blood, which was 63% (95% CI, 48%-77%). This occurred in a patient population that has previously been treated with, and progressed on, 2 of the most effective therapies, Brander emphasizes.

Responses have been observed in a subgroup of patients who have maintained long-term responses, she adds. Although these outcomes are primarily observed in patients who achieved undetectable MRD by the end of treatment, Brander continues. Investigators have observed response durations exceeding a year among patients with some residual disease. This is particularly significant for patients on this study, due to their heavily pretreated status. Brander adds. Moreover, patients do not typically undergo any treatments following the dose of CAR T-cell therapy, she concludes.