Positive topline results from the UNITY-CLL phase III study of the combination of umbralisib and ublituximab (U2) for the treatment of chronic lymphocytic leukemia.- TG Therapeutics

TG Therapeutics, Inc.has announced positive topline results from the global UNITY-CLL Phase III trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in patients with previously untreated and relapsed/refractory chronic lymphocytic leukemia (CLL).

The trial met its primary endpoint at a prespecified interim analysis demonstrating a statistically significant improvement in progression-free survival (PFS) (p<.0001), and will be stopped early for superior efficacy. PFS was assessed by an Independent Review Committee (IRC), and benefit was also seen across both previously untreated and relapsed/refractory patient populations.

The UNITY-CLL Phase III trial is being conducted under Special Protocol Assessment (SPA) agreement with the FDA. An independent data safety monitoring board (DSMB) conducted the interim analysis and made the recommendation to stop the trial early based on the positive results. Secondary endpoints, including safety, were not reviewed by the DSMB at this meeting. Data from this study is intended to support a regulatory submission targeted by year-end 2020 for U2 in both previously untreated and relapsed/refractory CLL patients and will be submitted for presentation at a future medical conference.