Improvement in survival seen with measurable residual disease-directed ibrutinib-venetoclax versus fludarabine-cyclophosphamide-rituximab
By Elana Gotkine HealthDay Reporter
WEDNESDAY, Dec. 13, 2023 (HealthDay News) — For patients with chronic lymphocytic leukemia (CLL), measurable residual disease (MRD)-directed ibrutinib-venetoclax treatment improves progression-free and overall survival, according to a study published online Dec. 10 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 9 to 12 in San Diego.
Talha Munir, Ph.D., from the University of Leeds in the United Kingdom, and colleagues conducted a multicenter randomized trial involving 523 patients with untreated CLL who were randomly assigned to ibrutinib-venetoclax or ibrutinib monotherapy with fludarabine-cyclophosphamide-rituximab (FCR). In the ibrutinib-venetoclax group, ibrutinib was given for two months, then venetoclax was added for up to six years. The duration of therapy was defined by MRD assessed in peripheral blood and bone marrow.
The researchers found that 12 and 75 patients in the ibrutinib-venetoclax and FCR groups, respectively, had disease progression or death at a median of 43.7 months (hazard ratio, 0.13). Death occurred in nine and 25 patients, respectively (hazard ratio, 0.31). Fifty-eight percent of patients in the ibrutinib-venetoclax group had stopped therapy at three years due to undetectable MRD. After five years of ibrutinib-venetoclax therapy, 65.9 and 92.7 percent of patients had undetectable MRD in the bone marrow and peripheral blood, respectively.
“The results appear better than those in previous studies of ibrutinib monotherapy or venetoclax, as monotherapy or in combination with anti-CD20,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Janssen, Pharmacyclics, and AbbVie, which partially funded the study.
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