THURSDAY, May 30, 2019 (Pharmacist's Briefing) -- For high-risk and older patients with previously untreated chronic lymphocytic leukemia (CLL), the combination of ibrutinib and venetoclax is an active regimen, according to a study published in the May 30 issue of the New England Journal of Medicine.
Nitin Jain, M.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted a phase 2 study of combined ibrutinib and venetoclax involving previously untreated high-risk and older patients with CLL. Patients were aged 65 years or older or had at least one of the following: chromosome 17p deletion, chromosome 11q deletion, mutated TP53, or unmutated IGHV. Eighty patients received ibrutinib monotherapy for three cycles followed by the addition of venetoclax.
The researchers found that the proportion of patients who had complete remission (with or without normal blood count recovery) and remission with undetectable minimal residual disease increased over time with combined treatment. After 12 cycles of combined treatment, 88 and 61 percent of patients had complete remission or complete remission with incomplete count recovery and remission with undetectable minimal residual disease, respectively. In older adults and across all high-risk subgroups, responses were noted.
"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," the authors write.
The study was partially supported by AbbVie, the manufacturer of venetoclax.