Chronic Lymphocytic Leukemia Coverage from Every Angle

EHA25 Virtual: Trial Update on Ibrutinib Plus Umbralisib in Resistant CLL

By: Kelly M. Hennessey, PhD
Posted: Friday, June 26, 2020

Initial results from a multicenter, phase I/!b trial suggested the doublet combination of ibrutinib and the dual PI3K-delta and CK1-epsilon inhibitor umbralisib was safe and active in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or mantle cell lymphoma. To assess long-term efficacy and durability of response, Matthew S. Davids, MD, of the Dana-Farber Cancer Institute, Boston and colleagues conducted an updated analysis, which was presented during the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual; Abstract EP689).

A total of 42 patients were treated with the combination therapy: 21 with CLL and 21 with mantle cell lymphoma. The median age was 68 years, and the median number of prior therapies was two.

In the updated analysis, no cumulative or late-onset toxicities were reported. The best overall response rate increased to 95% in patients with CLL and 71% in patients with mantle cell lymphoma. The complete response rate remained at 29% for those with CLL and rose from 19% to 24% in patients with mantle cell lymphoma. Progression-free survival and overall response was 10.8 months and 30.7 months, respectively, in patients with mantle cell lymphoma, but this had not been reached in patients with CLL.

“With long-term follow-up, ibrutinib plus umbralisib continues to demonstrate good tolerability, with a promising 4-year progression-free survival and overall survival of 78% and 90%, respectively, in relapsed or refractory CLL and similar efficacy as would be expected for ibrutinib alone in mantle cell lymphoma,” concluded the researchers.

Disclosure: For disclosures of the study authors, visit

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