Dr. Barr on Umbralisib/Ublituximab/Venetoclax in Relapsed/Refractory CLL

Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester, discusses the results of a phase I/II study evaluating the combination of umbralisib, ublituximab, and venetoclax (Venclexta) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL).

At the 2019 ASH Annual Meeting, data from this phase I/II trial were presented. In the phase I portion, 9 patients completed 1 year of treatment. Taken collectively with preliminary data from the phase II portion, investigators found that the regimen was well tolerated. Most of the adverse events were low-grade, says Barr. The majority of cytopenias were mild, and there weren’t any tumor lysis events.

Findings from the phase I portion showed that 4 of 9 patients achieved a complete response after completing 1 year of treatment. All 9 patients achieved undetectable minimal residual disease (MRD) in the peripheral blood, says Barr. Additionally, 7 of 9 patients had undetectable MRD in the bone marrow.

At the time of data cutoff, no patients had progressed. Given the early promise of the regimen, investigators have expanded the study to patients with Richter’s transformation, as well as mantle cell lymphoma.