TG Therapeutics Reports TGR-1202 in Combo with Ibrutinib, Recaps Long-Term Safety, Efficacy Data of TGR-1202 in CLL, NHLs

Loading...
Loading...
TG Therapeutics, Inc.
TGTX
today announced data presented during the 21st Annual Congress of the European Hematology Association (EHA) being held in Copenhagen, Denmark. These presentations include long term follow-up data of TGR-1202, the Company's once daily PI3K delta inhibitor, both alone and in combination with TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, as well as data presented for the first time from a Phase I/Ib study of TGR-1202 in combination with ibrutinib in patients with relapsed/refractory CLL or MCL. Michael S. Weiss, the Company's Executive Chairman and Interim CEO commented on the data, "EHA is a great opportunity to showcase to the European hematology community the exciting data for TGR-1202 and for the combination of TGR-1202 plus TG-1101 that we recently presented at ASCO. We were also excited to present for the first time, the safety and preliminary activity of the all oral combination of TGR-1202 and the BTK inhibitor, ibrutinib, by Dr. Matthew Davids and the team from Dana-Farber. We were pleased to report today that the data demonstrates that TGR-1202 at our Phase 3 dose of 800 mg plus full dose ibrutinib appears safe, well-tolerated and produced high response rates, especially in patients with advanced CLL, including one complete response, a depth of response not generally observed with either agent alone. We thank all the investigators involved and look forward to continued enrollment in the combination of TGR-1202 plus ibrutinib, as well as the ongoing triplet combinations with TGR-1202 and TG-1101 in combination with either ibrutinib, bendamustine or pembrolizumab." The following summarizes the posters presented yesterday and today during the EHA meeting: E-Poster Title: Preliminary results of a Phase I/Ib study of ibrutinib in combination with TGR-1202 in patients with relapsed/refractory CLL or MCL This poster includes data from patients with relapsed or refractory CLL or mantle cell lymphoma (MCL), all of whom were treated with TGR-1202 in combination with ibrutinib. A total of 27 patients were evaluable for safety, 17 patients with CLL and 10 with MCL, and 21 evaluable for efficacy, 11 patients with CLL and 10 with MCL (6 CLL patients were too early for assessment). CLL patients had a median of 2 prior lines of therapy (range 1-6), with 2 patients receiving prior ibrutinib and 2 receiving prior PI3K inhibitors. MCL patients had a median of 3 prior lines of therapy (range 2-5), with 2 patients also receiving prior ibrutinib. Highlights from this poster include: 82% (9/11) ORR in patients with CLL, with 1 patient achieving a CR confirmed by a negative bone marrow and several other patients approaching a CR radiographically 60% (6/10) ORR in patients with MCL, with clinical benefit observed in two additional patients The combination was well tolerated with no DLTs observed up to the highest dose tested (800 mg TGR-1202 + full dose ibrutinib) with the toxicity profile being comparable to the additive toxicity of the two agents given individually In addition to the above E-Poster, the Company is also presenting integrated analysis data from 165 patients with relapsed or refractory hematologic malignancies, which has been previously presented during the ASCO conference earlier this week. The data has been separated into two posters evaluating patients with CLL and then patients with NHL. Long-term follow-up of the next generation PI3K-delta inhibitor TGR-1202 demonstrates safety and high response rates in CLL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab (Abstract P207) Long-term follow-up of the next generation PI3Kδ inhibitor TGR-1202 demonstrates safety and high response rates in NHL: Integrated-analysis of TGR-1202 monotherapy and combined with ublituximab (Abstract P315) Updated information from the presentations at ASCO earlier this week include: Median Progression Free Survival (PFS) for TGR-1202 monotherapy was 24 months, while median PFS and DOR were not reached for TGR-1202 plus TG-1101 with median follow-up of 10.5 months, supporting our ongoing UNITY-CLL registration Phase 3 trial Median DOR of 12.1 months observed in DLBCL patients treated with TGR-1202 plus TG-1101, providing a strong rationale for our UNITY-DLBCL registration program Median DOR not reached in iNHL patients treated with TGR-1202 plus TG-1102 with a median follow-up of 15.8 months, further supporting our UNITY-iNHL registration directed trial, planned to launch by YE 2016
Loading...
Loading...
Posted In: NewsPress Releases
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...