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ASCO 2021: Fixed-Duration Treatment With Ibrutinib Plus Venetoclax in CLL

By: Julia Fiederlein
Posted: Friday, June 11, 2021

According to Paolo Ghia, MD, PhD, of Università Vita-Salute San Raffaele, Milan, and colleagues, first-line treatment with ibrutinib plus venetoclax provides deep, durable responses in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), including those with genomic high-risk features. Furthermore, the results from the fixed-duration cohort of the multicenter phase II CAPTIVATE trial, which were presented during the virtual edition of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 7501), did not reveal any new safety signals.

A total of 159 patients were administered 3 cycles of ibrutinib followed by 12 cycles of ibrutinib plus venetoclax. The complete response rate was 55% in the overall population; this seemed consistent across high-risk subgroups. Of the 88 patients who achieved a complete response, 78 had a durable complete response for at least 1 year.

The objective response rate was 96%. Best undetectable minimal residual disease (also known as measurable residual disease) responses were achieved in 77% of patients in the peripheral blood and 60% of patients in the bone marrow. The 24-month progression-free and overall survival rates were 95% and 98%, respectively; these results seemed similar in patients without del(17p). In those with del(17p) or TP53 mutations, the complete response rate was 56%, undetectable minimal residual disease rate was 81% in the peripheral blood and 41% in the bone marrow, and the 24-month progression-free survival rate was 84%.

A total of 94% of the patients with a high risk of tumor-lysis syndrome at baseline shifted to medium or low risk after treatment with ibrutinib. Most adverse events were grade 1 or 2. Neutropenia (33%), hypertension (6%), and decreased neutrophil counts (5%) were among the most commonly reported grade 3 or 4 adverse events. Adverse events led to the discontinuation of treatment with ibrutinib and venetoclax in 4% and 2% of patients, respectively.

Disclosure: For full disclosures of the study authors, visit coi.asco.org.



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