Positive topline results from the global phase III UNITY-CLL trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab (Gazyva) plus chlorambucil (Leukeran) in patients with previously untreated and relapsed or refractory chronic lymphocytic leukemia (CLL) were announced by TG Therapeutics, the developer of the combination.
The trial met its primary endpoint at a prespecified interim analysis, demonstrating a statistically significant improvement in progression-free survival (PFS; P< 0.0001), and will be stopped early for superior efficacy. Notably, PFS was assessed by an Independent Review Committee (IRC), and benefit was also observed across both previously untreated and relapsed or refractory patient populations.
An independent data safety monitoring board (DSMB) conducted the interim analysis and made the recommendation to stop the trial…
