The following is a summary of “Real-World Effectiveness and Safety Outcomes of Acalabrutinib Treatment By Line of Therapy in Patients with Chronic Lymphocytic Leukemia and/or Small Lymphocytic Lymphoma,” published in the December 2023 issue of Hematology by Jacobs et al.
Acalabrutinib is a 2nd generation Bruton tyrosine kinase inhibitor (BTKi) approved for the treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Acalabrutinib demonstrated sustained efficacy in phase 3 trials with manageable cardiovascular (CV) and bleeding events.
Researchers performed a retrospective study to describe the effectiveness and safety of acalabrutinib in patients with CLL or SLL who received first-line (1L) or later-line (2L+) acalabrutinib.
They analyzed Optum Clinformatics© Data Mart claims and electronic medical record database. The goal was to identify patients aged ≥18 years with treatment-naive (TN) or r/r CLL/SLL who initiated acalabrutinib in any line of therapy (LoT). CLL/SLL patients in the Optum database for ≥6 months before acalabrutinib were followed until data availability, death, or study end. Treatment effectiveness was assessed through TTNT and OS.TTNT and OS were estimated using the KM method, while CV and bleeding events were assessed in all patients who started acalabrutinib. The analysis included patients who received 1L or 2L+ acalabrutinib therapy for all outcomes.
The results showed 530 patients among these, 63% (n=334) received 1L acalabrutinib, and 37% (n=196) received 2L+ acalabrutinib, with a mean age of 72.8 years in the 1L cohort and 74.2 years in the 2L+ cohort. Over 60% of patients in the 2L+ cohort had prior BTKi therapy. Gender and race distributions were similar between the cohorts. At baseline, 18.1%, 75.3%, and 16.0% of patients had atrial fibrillation/flutter, hypertension, and bleeding episodes. With a median follow-up of 8.9 months in the 1L cohort and 12.4 months in the 2L+ cohort, the median time to next treatment (TTNT) and oOS) was not reached in either cohort. At 18 months, 82% of patients in the 1L cohort and 78% in the 2L+ cohort remained on treatment. In progressed patients, the median TTNT was similar in the 1L and 2L cohorts (4.0 vs 4.2 months). The 18-month OS rates were similar between the cohorts (90% vs 85%). The rates of new atrial fibrillation/flutter, hypertension, and bleeding events were low in the 1L (2.7%, 8.9%, and 2.7%) and 2L+ (7.4%, 2.4%, and 3.3%) cohorts.
They concluded that acalabrutinib treatment demonstrated real-world effectiveness and safety in first-line and later-line therapy for CLL/SLL.