The U.S. Food and Drug Administration approved ibrutinib in combination with obinutuzumab for treatment-naïve patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. This is the first non-chemotherapy regimen indicated for this patient population.
The decision was based on results of the phase III iLLUMINATE trial. Patients were randomized to receive ibrutinib 420 mg continuously in plus obinutuzumab 1,000 mg intravenously (IV) for six cycles, or chlorambucil on days one and 15 of each cycle plus 1,000 mg IV obinutuzumab for six cycles.
After a median follow-up of 31 months, patients who received ibrutinib plus obinutuzumab achieved significantly longer median progression-free survival (PFS) than those receiving chlorambucil plus obinutuzumab (median = not evaluable vs. 19 months; hazard ratio [HR] = .023; 95% CI, 0.15-0.37). This resulted in a 77% reduction in risk of progression or death. The PFS benefit appeared to be greater among patients with high-risk disease, such as those with 17p deletion, TP53 mutation, 11q deletion, or unmutated immunoglobulin heavy chain gene (HR=0.15; 95% CI, 0.09-0.27). The overall response rate was 89% in the ibrutinib plus obinutuzumab group and 73% in the chlorambucil plus obinutuzumab group.
The most common adverse events associated with ibrutinib plus obinutuzumab were neutropenia (48%), thrombocytopenia (36%), rash (36%), diarrhea (34%), musculoskeletal pain (33%), bruising (32%), cough (27%), infusion related reaction (25%), hemorrhage (25%), and arthralgia (22%).
Source: PR Newswire