Real-World Analysis Shows Promising Outcomes, Safety With Ibrutinib in CLL

White blood cells in leukemia: © Катерина Євтехова - stock.adobe.com

A real-world analysis identified that ibrutinib (Imbruvica) remains a valuable treatment option for patients with chronic lymphocytic leukemia (CLL) due to its efficacy and tolerability.¹

The EVIdeNCE study (NCT03720561) was conducted in Italy and investigated the real-world persistence rate, patterns of use, and outcomes of ibrutinib in patients with CLL. At a median follow-up of 23.9 months, the 2-year retention rate was 70.2%, the 2-year progression-free survival (PFS) rate was 85.4%, and the 2-year overall survival (OS) rate was 91.7%. The median PFS was not reached.

Moreover, cardiovascular conditions did not appear to affect clinical outcomes.

“The EVIdeNCE prospective study provides a unique perspective on the clinical course of patients with CLL treated with single-agent ibrutinib in Italian clinical practice. In this unselected CLL patient population, characterized by a high level of comorbidities and unfavorable prognostic factors, the 2-year persistence rate was relatively high, and survival outcomes were favorable. As anticipated, patients treated upfront with ibrutinib exhibited more favorable outcomes, reaffirming the heightened efficacy of ibrutinib as an initial treatment for CLL,” study authors wrote in findings published in Cancers.

Regarding safety, the most common adverse events (AEs) were infections (30.7%), bleeding (12.9%), fatigue (10.0%), and neutropenia (9.7%). Grade 3/4 atrial fibrillation was reported in 3.9% of patients. AEs and toxicity were the cause of treatment discontinuation in 14.2% of patients. No new safety signals were identified during this study.

A total of 309 patients were included in the analysis, and 229 completed the 24-month observational period. Response to ibrutinib was observed in 75.9% (n = 202) of patients, and a clinical complete response occurred in 18.4% of patients.

Ibrutinib treatment interruption occurred in 34.6% (n = 106) patients, and the median interruption duration was 2 weeks. Most patients (60%, n = 63) had 1 treatment interruption period, while 29.8% (n = 92) permanently discontinued ibrutinib. AEs were the most common cause of treatment interruption.

“Taken together, the results of this study suggest that a better knowledge and expertise in managing AEs improved the long-term outcomes of patients with CLL treated with ibrutinib...A significant number of patients continued taking ibrutinib for more than 1 year. These encouraging findings indicate that ibrutinib is a viable treatment for patients diagnosed with CLL,” study authors wrote.

“Furthermore, the reassuring safety profile and the possibility of dose reduction and flexibility associated with ibrutinib suggest a favorable benefit–risk profile for the novel ibrutinib-venetoclax [Venclexta] combination,” authors added.

REFERENCE:

1. Mauro FR, Scalzulli PR, Scarfò L, Minoia C, Murru R, et al. Real-world outcome of treatment with single-agent ibrutinib in Italian patients with chronic lymphocytic leukemia: final results of the EVIdeNCE study. Cancers (Basel). 2024;16(6):1228. Published 2024 Mar 20. doi:10.3390/cancers16061228