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ASH 2025 | Real-world treatability with ibrutinib plus venetoclax in patients with CLL
Andrea Visentin, MD, PhD, University of Padua, Padua, Italy, discusses the treatability with ibrutinib plus venetoclax in patients with chronic lymphocytic leukemia (CLL) in the real world. The primary endpoint of the study was the discontinuation rate due to adverse events, which was nearly half of that reported in pivotal clinical trials. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
The combination treatment with ibrutinib plus venetoclax has been approved based on the pivotal clinical trial, the Phase II CAPTIVATE trial and the Phase III GLOW trial. We perform a retrospective study collecting the information of patients treated with ibrutinib plus venetoclax in the real life within the European Research Initiative on CLL Network. We were able to collect data from 220 patients with CLL who received the conventional leading phase of ibrutinib for three cycles...
The combination treatment with ibrutinib plus venetoclax has been approved based on the pivotal clinical trial, the Phase II CAPTIVATE trial and the Phase III GLOW trial. We perform a retrospective study collecting the information of patients treated with ibrutinib plus venetoclax in the real life within the European Research Initiative on CLL Network. We were able to collect data from 220 patients with CLL who received the conventional leading phase of ibrutinib for three cycles. Then venetoclax was started from the fourth cycle with the conventional ramp-up phases and the combination was given for additional 12 months. The primary endpoint for the study was the discontinuation rate due to adverse events. The secondary points were all the other adverse events and the efficacy data. As I said, we collected data from 220 patients from 45 institutions over 11 countries. The median age of this patient was 65 years old, the majority were males, 6% of the patients had an unmutated status of the immunoglobulin and only 4% of the patients had the TP53 abnormalities. We excluded some patients for further analysis because 14 of them were still receiving the ibrutinib bleeding phase and four patients discontinued prematurely ibrutinib mainly due to atrial fibrillation. So we focus on the further analysis on 202 patients. We observed that the discontinuation rate was pretty low after a median follow-up of 10 months. It was about 4%. And if we focus on a young patient that is a CAPTIVATE-like population, only 3.2 percent of the patients discontinued the treatment. Instead focusing on a more elderly patient or in the comorbid without pivotal pre abnormalities such as a GLOW-like population only 4.9 percent of the patients discontinued the treatment due to adverse events. This is remarkable because it is almost about half of the rate recorded in the pivotal clinical trial. Regarding the efficacy, about 190 patients were treated for at least six months of treatment, so they were available for response assessment and the overall response assessment was above 90%, suggesting the efficacy and the reliability of this combination in the real life setting.
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