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Jeremy S. Abramson, MD, MMSc
Jeremy S. Abramson, MD, MMSc
Posted: Tuesday, January 21, 2025
The TRANSCEND CLL 004 Study, conducted by William G. Wierda, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues, evaluated the CD19-directed immunotherapy lisocabtagene maraleucel plus the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib among patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Presented during the 2024 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 887), the results of the trial support this regimen as a “promising new therapeutic strategy” for patients with this type of hematologic malignancy.
This open-label, phase I/II trial enrolled 56 adults with CLL or SLL who received BTK inhibitors and had progressive disease, had high-risk disease after more than 6 months on BTK inhibitors, had a BTK/PLCγ2 mutation and experienced disease progression on ibrutinib, received prior BTK inhibitors with no contraindications to ibrutinib, and/or experienced disease progression on a BTK inhibitor and received prior venetoclax (BCL2 inhibitor). Participants continued ibrutinib plus lisocabtagene maraleucel at a target dose of 50 x 106 chimeric antigen receptor–positive T cells.
A total of 28 patients discontinued treatment, 17 continued treatment, and 11 completed the study by the data cutoff. The objective response rate was 86% at dose level 2, and the median duration of response was 41.4 months. The rate of complete response was 45%, with a median time to a complete response of 3.1 months. The median progression-free survival was 31.4 months, and overall survival was not reached.
Most patients reported a treatment-emergent adverse event of grade 3 or higher (86%), with the most common being neutropenia (52%) and anemia (41%); no grade 5 events were reported. Adverse events attributed to lisocabtagene maraleucel were reported in 57% of patients, whereas events related to ibrutinib affected 43%. Cytokine-release syndrome and neurologic events of any grade occurred in 80% and 41% of patients, respectively; 16 patients died after infusion of lisocabtagene maraleucel.
Disclosure: For full disclosures of the study authors, visit ash.confex.com.
2024 ASH Annual Meeting & Exposition
