Key clinical point:
Major finding: The progression-free survival benefit with ibrutinib was sustained at a median follow-up of 44 months (hazard ratio, 0.133; 95% confidence interval, 0.099-0.178).
Study details: A post hoc analysis of 391 patients with relapsed or refractory chronic lymphocytic leukemia from the RESONATE study.
Disclosures: The study was sponsored by Pharmacyclics and Janssen. The authors reported financial disclosures related to the sponsors and several other companies.
Byrd JC et al. Blood. 2019 Mar 6..
Dr. David Henry, Editor in Chief of MDedge Hematology/Oncology, comments:
Many chronic lymphocytic leukemia (CLL) patients will require no therapy and do quite well with just watchful waiting, but some are symptomatic and/or have lymphadenopathy, organomegaly, and complete blood count abnormalities that require treatment.
Even more difficult is the CLL patient who has relapsed or is refractory after receiving first-line therapy.
Several years ago, the RESONATE trial was reported including 391 high-risk patients with CLL who were randomized 1:1 to receive ibrutinib 420 mg daily or ofatumumab periodic infusions.
In Blood, Dr. John Byrd and colleagues from Ohio State University report that these responses continue, even in the relapsed/refractory patient population in this update of the RESONATE trial.
With a median follow-up of 9.7 months, ibrutinib was superior to ofatumumab in both progression free and overall survival, and even overall response. These durable remissions were noted even in the most difficult patients including deletion 17, deletion 11, and unmutated IgHV. Furthermore, ibrutinib had a very good safety profile over this period of time.
These data continue to offer great promise for our patients with refractory/relapsed CLL who may benefit from an outpatient pill instead of repeated infusions in the infusion center.