Dr. Davids on the Design of the Phase 3 UNITY Trials in Relapsed/Refractory CLL and MCL

Matthew S. Davids, MD, MMSc, an associate director with the Center for Chronic Lymphocytic Leukemia; director of clinical research, Lymphoma Program; and medical oncologist, Dana-Farber Cancer Institute; and an assistant professor of medicine at Harvard Medical School, discusses the design of the UNITY trials in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).

Due to the significant toxicity of combining a SIK inhibitor with a PI3K inhibitor, UNITY-CLL evaluated umbralisib, an investigational oral PI3K delta inhibitor, plus ​the BTK inhibitor ibrutinib (Imbruvica) in patients with CLL was used in this analysis, says Davids. The same combination is being evaluated in patients with MCL in the UNITY-NHL trial.

The objective of the trials ​was to ​show that dual blockade of the B-cell receptor pathway could be done effectively while maintaining a manageable toxicity profile, David​s explains. 

The studies each enrolled 21 patients with relapsed/refractory CLL and MCL, says Davids. Some patients received prior ibrutinib monotherapy; however, they were not refractory to the BTK inhibitor, Davids concludes.