TG Therapeutics modifies Phase IIb trial of TGR-1202

TG Therapeutics Inc. (NASDAQ:TGTX) said an independent DSMB recommended discontinuation of the TGR-1202 (umbralisib) monotherapy arm of the Phase IIb UNITY-NHL trial in the diffuse large B cell lymphoma (DLBCL) cohort after a pre-planned interim analysis of overall response rate (ORR). The discontinued arm will be replaced with a triple combination of once-daily oral TGR-1202, IV ublituximab (TG-1101, TGTX-1101) and IV bendamustine.

The open-label, international trial is evaluating overall response rate (ORR), the primary endpoint, in about 500 patients with non-Hodgkin's lymphoma (NHL). The secondary endpoint is progression-free survival (PFS)...