First-Line Ibrutinib Treatment of CLL: 5-Year Follow-up Results
Posted: Wednesday, April 29, 2020
For patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), a single-agent treatment with ibrutinib offered sustained survival benefits for patients, when compared with chlorambucil, according to findings from the phase III RESONATE-2 study presented at the 2020 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference (Abstract CT02). Jan Burger, MD, PhD, of the MD Anderson Cancer Center at The University of Texas, Houston, and colleagues, reported their results as part of the longest follow-up study to-date for first-line Bruton’s tyrosine kinase–directed therapy.
“With up to 5.5 years of follow-up, 58% of patients remain on long-term continuous ibrutinib treatment,” the authors noted.
In this trial, the authors enrolled 269 patients (aged at least 65 years) with previously untreated CLL or SLL. Patients were treated with 420 mg of ibrutinib continuously or 0.5 to 0.8 mg/kg of chlorambucil for up to 12 cycles.
The investigators found that the median progression-free survival was not reached for patients treated with ibrutinib, compared with 15 months for patients treated with chlorambucil. For those in the ibrutinib group, 5-year progression-free survival estimates were 70%, compared with 12% for those in the chlorambucil cohort; improved overall survival estimates were also higher with ibrutinib (5-year estimate, 83%) versus chlorambucil (68%). Patients treated with ibrutinib exhibited an overall response rate of 92%, and complete response rates increased from 11% after a median follow-up of 18 months to 30% after 5 years.
The most grade 3 or higher adverse events were neutropenia (13%), pneumonia (12%), and hypertension (8%). For the 27 patients with a reduced dosage because of adverse events, 25 (93%) experienced subsequent improvement or resolution of adverse events.
Disclosure: For full disclosures of the study authors, visit hoparx.org.
