TG Therapeutics has secured a positive recommendation from the independent Data Safety Monitoring Boards (DSMBs) that evaluated data from the UNITY-CLL and UNITY-NHL clinical trials.
Based on the progression-free survival findings from the Phase III UNITY-CLL trial, DSMB said that the study can be continued as planned in treatment naïve, relapsed or refractory chronic lymphocytic leukaemia (CLL) patients.
The randomised, controlled trial is designed to compare ublituximab and umbralisib combination (U2) with an active control arm of obinutuzumab plus chlorambucil.
UNITY-CLL DSMB also analysed safety data from more than 600 enrolled CLL patients. No safety concerns were observed and the monitoring board recommended that the trial can be continued without any modification.
Meanwhile, UNITY-NHL DSMB reviewed safety results from more than 470 participants with non-Hodgkin’s lymphoma (NHL) across all cohorts of the trial.
The board did not identify any safety concerns and recommended the continuation of the UNITY-NHL trial as planned.
UNITY-NHL is a global, multi-cohort Phase IIb trial assessing the efficacy and safety of umbralisib monotherapy and in combination with ublituximab in previously treated NHL patients.
TG Therapeutics executive chairman and CEO Michael Weiss said: "We are highly encouraged that based on the progression-free survival data accumulated to date, the UNITY-CLL DSMB determined that the study was not futile and supported continuation of the trial as planned.
“We are also extremely pleased that the DSMBs, which collectively evaluated safety data from over 750 patients treated with umbralisib, did not raise any safety concerns and recommended that both the UNITY-CLL and the UNITY-NHL trials continue unmodified.”
The UNITY-CLL trial comprises two single-agent arms for ublituximab and umbralisib, respectively, along with an ublituximab plus umbralisib treatment arm and an active control obinutuzumab plus chlorambucil arm.
The primary objective of this Phase III trial is superiority in progression-free survival (PFS) for the U2 combination therapy over the control arm.
The UNITY-NHL trial currently includes cohorts for marginal zone lymphoma (MZL), follicular lymphoma (FL) / small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL).