Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004.
Publication/Presentation Date
7-28-2026
Abstract
Patients in the liso-cel plus ibrutinib cohort of the phase 1/2, open-label TRANSCEND CLL 004 study had relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and received liso-cel (50×106 [dose level (DL)1] or 100×106 [DL2] chimeric antigen receptor-positive T cells) with concurrent ibrutinib from enrollment through 90 days after liso-cel infusion or longer per investigator discretion. Primary end point was complete response/remission (CR)/CR with incomplete marrow recovery (CRi) by investigator assessment. Among 56 patients who received ibrutinib plus liso-cel (DL1, n=5; DL2, n=51), median (range) age was 64.5 years (44‒77), 98% had high-risk cytogenetics, 55% had progression on Bruton tyrosine kinase inhibitor and venetoclax failure, and median (range) number of prior therapies was 5 (1‒13). Median (range) follow-up was 24.8 months (3.1‒51.8). At DL2, CR/CRi rate was 45% (95% confidence interval [CI], 31‒60) and overall response rate was 86% (95% CI, 74‒94). Median (95% CI) duration of response was not reached (NR; 28.7‒NR) for patients with CR/CRi and 41.4 months (23.3‒NR) for all responders. Median (95% CI) progression-free survival was 31.4 months (20.1‒NR). In DL1+DL2, most common grade ≥3 treatment-emergent adverse events (TEAE) were neutropenia (52%) and anemia (41%). Cytokine release syndrome was reported in 80% of patients (grade 3, 4%; no grade 4/5), and neurological events in 41% (grade 3/4, 11%; no grade 5). Ibrutinib-related TEAEs were reported in 68% of patients (grade 3/4, 43%; no grade 5). Liso-cel plus ibrutinib demonstrated notable efficacy in patients with relapsed/refractory CLL/SLL with predictable and manageable safety. Clinicaltrials.gov: NCT03331198; NCT03435796.
ISSN
1528-0020
Published In/Presented At
Wierda, W. G., Dorritie, K. A., Gauthier, J., Nath, R., Kipps, T. J., Riedell, P. A., Eradat, H. A., Kenderian, S. S., Kharfan-Dabaja, M. A., Shah, N. N., Solomon, S. R., Stephens, D. M., Ermann, D. A., Arnason, J. E., Deol, A., Feldman, T. A., Andreadis, C. B., Ghosh, M., Ma, S., Schuster, S. J., … Siddiqi, T. (2026). Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004. Blood, blood.2026033565. Advance online publication. https://doi.org/10.1182/blood.2026033565
Disciplines
Medicine and Health Sciences
PubMedID
42520199
Department(s)
Department of Medicine, Hematology-Medical Oncology Division
Document Type
Article