DSMB recommends continuation of TG's TGR-1202 Phase III trial

TG Therapeutics Inc. (NASDAQ:TGTX) said an independent DSMB recommended the company cease enrollment in the 2 monotherapy arms of the Phase III UNITY-CLL trial evaluating ublituximab (TG-1101, TGTX-1101) and TGR-1202 to treat chronic lymphocytic leukemia (CLL). TG said the DSMB determined that contribution of single agents has been "sucessfully established" based on a review of overall response rate (ORR) data from about 50 patients in each of the 4 study arms. The DSMB also reviewed safety data from >270 patients, citing no safety concerns and recommending continuation without modification. The company will continue to enroll patients in the 2 combination arms.

The open-label, international trial is comparing IV ublituximab and oral TGR-1202 alone or in combination vs. IV Gazyva obinutuzumab plus oral chlorambucil. Patients receive ublituximab on days 1, 8 and 15 followed by maintenance infusions and TGR-1202 once daily...