Chronic Lymphocytic Leukemia Coverage from Every Angle

ASH 2020: PI3K Inhibitor Plus Monoclonal Antibody Versus Chemoimmunotherapy for CLL

By: Julia Fiederlein
Posted: Monday, December 14, 2020

According to John G. Gribben, MD, DSc, of the Queen Mary University of London, United Kingdom, and colleagues, patients with treatment-naive or relapsed or refractory chronic lymphocytic leukemia (CLL) experienced superior progression-free survival after treatment with umbralisib plus ublituximab compared with those who were treated with standard chemoimmunotherapy. The multicenter phase III UNITY-CLL trial results were presented during the virtual edition of the 2020 American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract 543).

“Umbralisib is an oral, once-daily, novel, dual inhibitor of phosphatidylinositol-3-kinase-delta and casein kinase-1ε,” the investigators noted. “Ublituximab is a novel anti-CD20 monoclonal antibody.”

Initially, patients were randomly assigned in a 1:1:1:1 ratio to receive umbralisib plus ublituximab, obinutuzumab plus chlorambucil, umbralisib monotherapy, or ublituximab monotherapy. Subsequently, the patients were randomly assigned in a 1:1 ratio to receive umbralisib plus ublituximab (n = 210) or obinutuzumab plus chlorambucil (n = 211).

The median duration of progression-free survival with umbralisib plus ublituximab and obinutuzumab plus chlorambucil was 31.9 versus 17.9 months, respectively (P < .0001). The estimated 24-month progression-free survival rate was higher with umbralisib plus ublituximab (60.8%) than with chemoimmunotherapy (40.4%). This progression-free survival benefit was also observed in the treatment-naive (median 38.5 vs. 26.1 months) and relapsed or refractory (median 19.5 vs. 12.9 months) subgroups.

The independent review committee–assessed objective response rate was 83.3% with umbralisib plus ublituximab and 68.7% with chemoimmunotherapy (P < .001). Among patients who were previously treated with ibrutinib (6%), the objective response rate was higher with umbralisib plus ublituximab than with chemoimmunotherapy (57% vs. 25%, respectively). Neutropenia, thrombocytopenia, diarrhea, infusion-related reaction, elevated levels of aspartate transaminase/alanine transaminase, colitis, and pneumonitis were among the most frequently reported grade 3 or 4 adverse events.

Disclosure: For full disclosures of the study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.