Dr. Davids on the Design of the Phase 3 UNITY Trials in Relapsed/Refractory CLL and MCL
Matthew S. Davids, MD, MMSc, discusses the design of the UNITY trials in patients with relapsed/refractory chronic lymphocytic leukemia and mantle cell lymphoma.
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, Davids 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.
