Discussing the Efficacy of a Phase 1/2 Study in R/R CLL

Paul Barr, MD, an associate professor of Medicine and director of the Clinical Trials Office for the Wilmot Cancer Institute and medical director of the Cancer Center Clinical Trials Office at the University of Rochester Medical Center, discusses treatment with umbralisib (TGR-1202), ublituximab (TGTX-1101), and venetoclax (Venclexta) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

In this study. patients were initially treated with 3 cycles of umbralisib, a novel small molecule inhibitor that targets PI3K-delta and CK1-epsilon, and ublituximab, a novel CD20 antibody. Barr says that in the first 3 cycles, all patients, including those that progressed on Bruton’s kinase inhibitors, responded. This combination decreased the CLL tumor burden, which reduced the risk of tumor lysis related to treatment with venetoclax.

After the first cycles of umbralisib and ublituximab, patients were given 9 cycles of venetoclax, bringing the treatment time to a total of a about 1 year. By the end of that year, all patients had responded to therapy. A little more than 3 quarters of patients had undetectable minimal residual disease in their bone marrow. Patients responded well to treatment, had deep remissions, and a majority have stopped therapy, according to Barr. Median follow-up was about a year and a half, and so far only 1 patient has progressed.