Long-Term Data Support Ibrutinib Monotherapy in Patients With CLL/SLL
Posted: Monday, May 18, 2020
In the longest extended follow-up to date—up to 8 years—of any study examining the single-agent use of a Bruton’s tyrosine kinase inhibitor, researchers demonstrated the overall safety and efficacy of ibrutinib in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). John C. Byrd, MD, of The Ohio State Medical School in Columbus, and colleagues published the results of their pivotal phase Ib/II and extension studies in Clinical Cancer Research. In the 132 patients ultimately treated with the once-daily agent, the estimated 7-year overall survival and progression-free survival rates were 84% and 83% in the first-line setting and 55% and 34% in the relapsed or refractory setting, respectively.
The median age of the 31 patients treated with first-line ibrutinib was 71 years, and it was 64 years for the 101 patients with relapsed or refractory disease; the latter group also had a median of four prior therapies. The overall response rate was 89% across the entire cohort.
“In relapsed/refractory CLL/SLL, median progression-free survival was 52 months overall,” stated Dr. Byrd and co-investigators. It was “26 months in patients with chromosome 17p deletion, 51 months [in those] with 11q deletion, not reached [in those] with trisomy 12 or 13q deletion, and 88 months in patients without these cytogenetic abnormalities.” The median progression-free survival was not reached with first-line ibrutinib.
A total of 41 patients experienced CLL progression, 11 with Richter’s transformation, the team pointed out. They also noted that the grade ≥ 3 adverse events occurring in more than 15% of patients were hypertension (28%), pneumonia (24%), and neutropenia (18%). However, pneumonia and neutropenia generally declined over time.
Disclosure: The study authors’ disclosure information can be found at aacrjournals.org.