ASH 2015: Ibrutinib Data Underscore Promise of Targeted Therapies as First-Line Approach for Patients With Chronic Lymphocytic Leukemia
A presentation by Tedeschi et al at the 57th American Society of Hematology (ASH) Annual Meeting outlined results of the phase III RESONATE TM-2 study of ibrutinib (Imbruvica) vs chlorambucil (Leukeran) in patients aged 65 years and older with treatment-naive chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [Abstract 495].
CLL/SLL primarily affects older patients who often have other chronic diseases or conditions. In this population of patients, chlorambucil has been a standard first-line therapy.
Study Details
This randomized, phase III study sought to evaluate the efficacy and safety of ibrutinib, a first-in-class, oral, Bruton’s tyrosine kinase inhibitor that targets B-cell malignancies in newly diagnosed, previously untreated older patients with CLL/SLL.
Investigators randomly assigned 269 patients with a median age of 73 years to receive either continuous daily doses of ibrutinib or the chemotherapy drug chlorambucil for up to 12 treatment cycles.
Key Findings
Based on investigator assessment, patients who received ibrutinib achieved an 18-month progression-free survival rate of 93.9% vs 44.8% in patients treated with chlorambucil. In addition, patients who received ibrutinib achieved a 24-month overall survival rate of 97.8% vs 85.3% in patients treated with chlorambucil.
The investigators concluded: “Treatment with single-agent ibrutinib was superior to chlorambucil in terms of progression-free survival, overall survival, overall response rate, event-free survival, and hematologic improvement in treatment-naive older CLL/SLL patients, with an 84% reduction in risk of death, and an acceptable safety profile.”
The results underscored that targeted therapy is effective in patients with previously untreated CLL/SLL, and suggested that ibrutinib should be the standard of care for this population.
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