Use of Ibrutinib as Initial Therapy for Chronic Lymphocytic Leukemia in Real-World Setting Aligns With Clinical Trials
According to findings from a systematic literature review, real-world data indicates that the use of the oral Bruton’s tyrosinase inhibitor, ibrutinib, as initial therapy for the treatment of chronic lymphocytic leukemia (CLL), including patients who are classified as having high-risk genomic features, aligns with the findings from randomized clinical trials. (Drugs Real World Outcomes. 2022. https://doi.org/10.1007/s40801-022-00332-4).
Philip Lee, MD, Pharmacyclics LLC, an AbbVie Company, South San Francisco, CA, and colleagues sought to evaluate the clinical effectiveness of ibrutinib as a first-line treatment of CLL in real-world clinical settings by conducting a systematic literature review.
The researchers compiled and reviewed articles published in the United States from MEDLINE, EMBASE, and relevant conference websites between the period of January 1, 2014, to June 30, 2020. Parameters including overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and time to next treatment were evaluated.
Data from 112 to 2033 patients from community and academic centers and the multicenter informCLL registry from a total of 12 publications were included in this systematic literature review.
The patient population was comprised primarily of males representing an estimated 60% to 99%, and the average age range was reported as 62 to 77 years. The study population also included individuals who were classified as having high-risk genomic features, and an estimated 59% had the unmutated immunoglobulin heavy chain variable gene.
With regard to their findings, the authors wrote, “This systematic review, which includes OS, PFS, and ORR data from 12 observational studies, confirms the effectiveness of ibrutinib as first-line treatment in patients with CLL in real-world clinical practice,” adding, “Treatment with ibrutinib led to a robust response, with 12-month PFS rates that ranged from 89 to 93% across three studies and 18-month and 24-month rates of 84% and 82%, respectively, reported in another study.“
The authors also indicated that rates for OS were equally remarkable, reporting that at 18 months and 30 months, 91% and 89% of patients were estimated to be alive, respectively. Moreover, across all included studies, in spite of significant differences in study design, patient populations, and outcome definitions, the beneficial clinical effects associated with the use of ibrutinib as initial therapy was reported.
The authors concluded that in the real-world setting, this systematic literature review validated the real clinical benefits of prescribing the agent ibrutinib as an initial treatment of CLL which was associated with a noteworthy impact on PFS and OS in patients with previously untreated CLL, including patients with high-risk genomic features who are recognized to have poor outcomes. The findings also provide clinical evidence for using ibrutinib in a larger patient population based outside of clinical trials and has demonstrated the real-world effectiveness of this agent.
“Findings in this analysis complement the results observed in clinical trial populations and confirm the benefit of ibrutinib for first-line treatment in CLL in a broader population of patients outside of a clinical trial setting,” wrote the authors, concluding, “Real-world evidence for other targeted agents in first-line treatment of CLL is awaited and will further inform clinical practice.”
