Ibrutinib Safe, Effective for the Treatment of Relapsed/Refractory CLL

Study findings suggest that single-agent ibrutinib is safe and effective for relapsed/refractory chronic lymphocytic leukemia (CLL) in routine practice (Clin Lymphoma Myeloma Leuk. 2021; S2152-2650[21]02040-1. doi:10.1016/j.clml.2021.09.010).

Novel agents targeting the B-cell receptor pathway and BCL-2 have changed the therapeutic landscape of CLL.

“We evaluated the safety and efficacy of single-agent ibrutinib in relapsed/refractory CLL in real-world settings,” wrote Seval Akpinar, MD, Department of Internal Medicine, Division of Hematology, Tekirdağ Namık Kemal University Medical School, Tekirdağ, Turkey.

A retrospective, multicenter non-interventional study of patients with relapsed/refractory CLL was conducted using data collected from patient charts at participating centers.

The median age of the 200 patients participating in this study was 68 years. The median lines of previous chemotherapy was 2. Among participants, 31.8% had del17p and/or p53 mutations. In total, 75% of patients achieved at least partial response, and treatment-emergent adverse events caused 8.7% of patients to discontinue ibrutinib.

Neutropenia and thrombocytopenia were present in 17.4% and 22.3% of patients, respectively, making them the most common drug-related adverse events observed in this study. The most common nonhematologic treatment-emergent adverse event was pneumonia. Atrial fibrillation was observed in 2.8% of participants, and bleeding was observed in 6.3%.

The median follow-up period was 17 months, and within that time, 21% of patients died. The median OS of the study cohort was estimated to be 52 months. The response to ibrutinib was associated with OS.

“Our results indicate good safety and efficacy for single-agent ibrutinib in R/R CLL in daily practice,” concluded Dr Akpinar and colleagues.