Newer Treatment Regimen for High-Risk and Older Patients With CLL
Posted: Tuesday, September 3, 2019
The combination of the Bruton’s tyrosine kinase inhibitor ibrutinib and the B-cell lymphoma 2 protein inhibitor venetoclax appears to be an effective oral regimen for both high-risk and older patients with chronic lymphocytic leukemia (CLL). The single-center phase II study was conducted by Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center and colleagues, and published in The New England Journal of Medicine.
“High rates of complete response and remission with undetectable minimal residual disease in bone marrow were noted with this regimen without unanticipated toxic effects at early time points of follow-up,” concluded the authors.
From July 2016 to June 2018, 80 patients with previously untreated high-risk CLL and older patients (at least age 65) with CLL received a combination of ibrutinib and venetoclax. High-risk patients were defined as those with chromosome 17p deletion, mutated TP53, chromosome 11q deletion, or unmutated IGHV. Patients were given 420 mg of ibrutinib daily for three 28-day cycles, followed by venetoclax at a weekly dose escalation to 400 mg once daily. The treatment lasted for 24 cycles.
With this combined treatment, the proportion of patients with complete remission with or without normal blood cell count recovery and remission with undetectable minimal residual disease increased over time. After receiving 12 cycles of treatment, 88% of patients had complete remission with incomplete blood cell count recovery. In addition, 61% had remission with undetectable minimal residual disease. After 18 months of treatment, these numbers increased to 96% and 69%, respectively. These responses were seen in both older adults and all of the high-risk subgroups, with estimated 1-year progression-free and overall survival rates for all groups reaching 98% or higher.
Disclosure: The study authors’ disclosure information may be found at nejm.org.