On June 07, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported the enrollment of its first patient in its registration-directed UNITY-DLBCL Phase 2b clinical study evaluating TG-1101, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with TGR-1202, the Company’s orally available PI3K delta inhibitor, as well as TGR-1202 alone, in patients with previously treated Diffuse Large B-Cell Lymphoma (DLBCL) (Press release, TG Therapeutics, JUN 7, 2016, View Source [SID:1234513116]). Schedule your 30 min Free 1stOncology Demo! The study, entitled "A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 and TGR-1202 alone in Patients with Previously Treated Diffuse Large B-Cell Lymphoma," is being led by Owen A. O’Connor, MD, PhD, Professor of Medicine and Experimental Therapeutics, and Director of the Center for Lymphoid Malignancies at Columbia University Medical Center. The primary objective of the study is to assess the efficacy of TGR-1202 alone and in combination with TG-1101 in patients with previously treated DLBCL as measured by Overall Response Rate (ORR). The study will also provide important information as to the contribution of each asset, TGR-1202 and TG-1101, to the combination of both agents. In addition to monitoring for safety and efficacy this study will analyze the impact of cell of origin (GCB vs. ABC ), mutational status and select biomarkers of efficacy.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Michael S. Weiss, Executive Chairman and Interim Chief Executive Officer of TG Therapeutics, stated, "We are excited to announce the enrollment of our first patient in our UNITY-DLBCL Phase 2b trial. We believe the foundation of our company lies in the approval of TG-1101 + TGR-1202, our proprietary ‘1303′ combination, across a wide variety of b-cell disorders and this trial marks another important step forward in achieving our goal. DLBCL is an area of significant unmet medical need, with no approved treatment options available for patients with relapsed/refractory disease and limited activity seen with other novel agents in this patient population. We are encouraged by the early data we have seen in our Phase I/II studies, as presented at the recent ASCO (Free ASCO Whitepaper) meeting, and look forward to evaluating the combination in this registration-directed trial."