TG Therapeutics Inc (NASDAQ:TGTX) has completed full enrollment in the planned UNITY-CLL Phase III clinical study. The UNITY-CLL Phase III study is a randomized trial of TG-1101 (ublituximab), the firm’s unique glycoengineered anti-CD20 monoclonal antibody, together with TGR-1202 (umbralisib), the firm’s PI3K delta inhibitor, together stated as the U2 regimen, versus an active control arm of obinutuzumab together with chlorambucil, in people with both treatments naïve and refractory or relapsed Chronic Lymphocytic Leukemia. The UNITY-CLL study is being performed under Special Protocol Assessment deal with the Food and Drug Administration.
Last month, TG Therapeutics reported that target enrollment of 175 subjects in each of the obinutuzumab plus chlorambucil and TG-1101 plus TGR-1202 arms was achieved. However, enrollment was stretched to permit eligible patients who were already listed or in screening the ability to partake in the trial.
Completion of full registration has now been achieved with over 200 subjects in each of the two combination arms. Around 60% of subjects registered in the combination arms were front-line while 40% were previously-treated.
The primary and secondary objective analyses will comprise all patients. Top-line ORR data from the UNITY-CLL study is anticipated in the Q2 2018 and the firm is targeting a Biologics License Application (BLA)/New Drug Application (NDA) submission for the combination of TG-1101 and TGR-1202 in the 2H2018.
Michael S. Weiss, the CEO and Executive Chairman of TG Therapeutics, reported that they are delighted to announce that UNITY-CLL has now concluded full enrollment, far surpassing the initial targeted enrollment and performing so much faster than expected.
They consider the remarkable demand for this trial underlines the need for new treatment alternatives for CLL patients and the enthusiasm particularly for the U2 plan. In addition, with the early conclusion of UNITY-CLL, the prospective filing timelines for UNITY-CLL and GENUINE are now almost overlapping, with a UNITY-CLL submission based on ORR possible in the Q3 2018.