Dr. Barr on the Safety Profile of Umbralisib/Ublituximab/Venetoclax in CLL

Paul M. Barr, MD, an associate professor of medicine and director of the Clinical Trials Office at the Wilmot Cancer Institute of the University of Rochester Medical Center, discusses the safety profile of umbralisib (Ukoniq) plus ublituximab and venetoclax (Venclexta) in chronic lymphocytic leukemia (CLL).

It was expected that the risk of cytopenias would be high with a combination that consists of a PI3K inhibitor and venetoclax, says Barr. Findings from a phase 1/2 trial showed consistent rates of cytopenias with what was anticipated with the triplet, Barr explains. Additionally, gastrointestinal (GI) adverse effects (AEs) are known toxicities of all 3 agents; however, dose-limiting GI AEs were rare, Barr says. Immune-related AEs, such as colitis and diarrhea, were consistent with the expected toxicities associated with umbralisib, Barr explains. In these cases, holding umbralisib and integrating steroids was helpful for patients, Barr adds.

Notably, no pneumonitis or grade 3 liver function test elevations were observed with the triplet, says Barr. Ultimately, the safety profile of umbralisib/ublituximab/venetoclax was consistent with what is expected from each agent as monotherapy, concludes Barr.