By Melissa Badamo - Last Updated: February 22, 2024
Measurable residual disease (MRD)-directed ibrutinib plus venetoclax therapy improved progression-free survival in patients with chronic lymphocytic leukemia (CLL) compared with fludarabine, cyclophosphamide, and rituximab (FCR), according to a phase III study.
Overall survival results also favored ibrutinib plus venetoclax, according to the researchers.
“MRD-directed ibrutinib–venetoclax improved progression-free survival as compared with FCR, and results for overall survival also favored ibrutinib–venetoclax,” according to the researchers, led by Talha Munir, PhD, of Leeds Teaching Hospitals NHS Trust in the United Kingdom, and published in The New England Journal of Medicine.
The multicenter, randomized, controlled, open-label trial enrolled a total of 523 patients who were randomly assigned to either the ibrutinib plus venetoclax group or the FCR group. In the ibrutinib plus venetoclax group, patients simultaneously received up to six years of venetoclax following two months of ibrutinib. The duration of ibrutinib plus venetoclax therapy was double the time taken to achieve undetectable MRD in the peripheral blood and bone marrow.
At a follow-up of three years, 58.0% of patients in the ibrutinib plus venetoclax group achieved undetectable MRD and stopped therapy. At a follow-up of five years, 65.9% of patients in the ibrutinib plus venetoclax group had undetectable MRD in the bone marrow, while 92.7% had undetectable MRD in the peripheral blood.
At a median of 43.7 months, disease progression or death occurred in 12 patients in the ibrutinib plus venetoclax group, compared with 75 patients in the FCR group (HR, 0.13; 95% CI, 0.07-0.24; P<0.001).
Furthermore, 10.7% of patients in the ibrutinib plus venetoclax group experienced cardiac serious adverse events, compared with 0.4% of patients in the FCR group. The risk of infection was similar in both groups.
Reference
Munir T, Cairns DA, Bloor A, et al. Chronic lymphocytic leukemia therapy guided by measurable residual disease. N Engl J Med. 2024. doi:10.1056/NEJMoa2310063
Original Source: Is Ibrutinib Plus Venetoclax Therapy Guided by MRD Effective in CLL? | Blood Cancers Today