Front-Line Ibrutinib plus Rituximab for Chronic Lymphocytic Leukemia

The oral Bruton tyrosine kinase inhibitor (TKI) ibrutinib (IBR) has demonstrated high activity in previously untreated and relapsed patients with chronic lymphocytic leukemia (CLL; NEJM JW Oncol Hematol Feb 2016 and N Engl J Med 2015; 373:2425; NEJM JW Oncol Hematol Sep 2014 and N Engl J Med 2014; 371:213).

Now, investigators have conducted a planned interim analysis of an industry-funded, multicenter, open-label, randomized phase III trial, in which 529 previously untreated CLL patients (age, ≤70 years) were randomized 1:2 to standard chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR) for 6 cycles versus TKI therapy with IBR (420 mg/d in 4-week cycles) plus rituximab (R) in cycles 2–6. Patients with del(17p) were exc…