Ibrutinib has a high overall response rate, with favorable risk-to-benefit profile, among patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and 17p deletion, according to a study published in The Lancet Oncology.1
Patients with 17p deletion CLL have poor responses and survival following treatment with chemoimmunotherapy. Researchers evaluated the activity and safety of the oral Bruton tyrosine kinase inhibitor, ibrutinib, among those with relapsed or refractory disease.
For this international, open-label, phase 2 trial, investigators enrolled 145 patients; each received ibrutinib 420 mg once daily until disease progression or unacceptable toxicity.
Median follow-up was 11.5 months. The overall response according to independent review committee assessment was 64% (95% CI, 56-71), and 83% (95% CI, 76-88) per investigator assessment.
The 24-month progression-free survival and overall survival rates were 63% (95% CI, 54-70) and 75% (95% CI, 67-81), respectively.
Seventeen percent of patients discontinued treatment due to adverse events, unacceptable toxicity, or death; 18 patients died as a result of adverse events.
These findings provide further evidence for the use of ibrutinib in this difficult-to-treat subset of patients with CLL or SLL.
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Ibrutinib is already approved by the U.S. Food and Drug Administration for patients with CLL or SLL with or without 17p deletion.
- O’Brien S, Jones JA, Coutre SE, et al. Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study. Lancet Oncol. 2016 Sep 14. doi: 10.1016/S1470-2045(16)30212-1 [Epub ahead of print]