Real-World Study Confirms Efficacy and Safety of Venetoclax-Based Regimens for Chronic Lymphocytic Leukemia

Venetoclax in combination with an anti-CD20 antibodies such as obinutuzumab or rituximab, or as a monotherapy demonstrated strong efficacy and a manageable safety profile among patients with chronic lymphocytic leukemia (CLL) in a real-world setting, according to study results published in Neoplasma.

Previous research has found venetoclax in combination with rituximab, obinutuzumab, and ibrutinib, as well as monotherapy, efficacious for the treatment of CLL. Researchers conducted a retrospective analysis to evaluate the safety and efficacy of venetoclax in a real-world population.

Overall, 43 patients with CLL were included with a median age of 58 years (range, 41 to 79), of these 15 patients were treated with venetoclax and obinutuzumab, 6 patients were treated with venetoclax and rituximab, and 22 patients received venetoclax monotherapy. Approximately 37% of patients had received prior ibrutinib.

The overall response rate (ORR) for the entire study population was 100%, with 40% of patients achieving complete remission (CR) and 60% achieving partial remission (PR).

Patients treated with venetoclax and rituximab had a higher CR rate (50%) than patients treated with venetoclax and obinutuzumab (40%) and patients treated with venetoclax monotherapy (36%). Conversely, patients treated with venetoclax monotherapy had a higher PR rate (64%) than patients treated with venetoclax and obinutuzumab (60%) and patients treated with venetoclax and rituximab (50%).

At time of assessment, patients treated with venetoclax and obinutuzumab had a PFS of 100%. The median progression-free survival (PFS) for patients treated with venetoclax and rituximab was 31 months (95% confidence interval [CI], 21.3 to 46.3) while median PFS was not reached in the venetoclax monotherapy group. Additionally, the overall survival (OS) rate at 36 months was 100% for patients treated with venetoclax and obinutuzumab, 50% for patients treated with venetoclax and rituximab, and 68% for patients who received venetoclax monotherapy.

In terms of safety, adverse events of any grade were reported the most among patients treated with venetoclax and rituximab (83%), compared to patients treated with venetoclax and obinutuzumab (68%) or venetoclax monotherapy (68%). The most reported adverse event was neutropenia, of which grade 3 or 4 neutropenia was recorded in 37% of patients in the venetoclax monotherapy group, 33% of patients in the venetoclax and rituximab group, and 26% in the venetoclax and obinutuzumab group.

"In accordance with the conclusions of clinical studies and retrospective analyses from real-world practice, venetoclax regimens in combination with an anti-CD20 antibody or as monotherapy can be considered effective regimens with good effect in patients with CLL in the first and higher line of treatment,” the researchers concluded.

“Our data suggest that venetoclax is effective in patients with high-risk genetic features, though larger studies are needed to confirm comparability to clinical trials," they added.

Source:

Holasová J, Wild A, Hrubiško M. Clinical experience and safety of venetoclax in the treatment of patients with chronic lymphocytic leukemia - real-world data from a hemato-oncology center. Neoplasma. Published online April 2025. doi:10.4149/neo_2025_241211N518