On June 15, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported updated clinical data from its Phase I/Ib trial of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with TGR-1202 (umbralisib), the Company’s oral, next generation PI3K delta inhibitor, and bendamustine, in patients with Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) (Press release, TG Therapeutics, JUN 15, 2017, View Source [SID1234519555]). Data from this trial was presented today during a poster session at the 14th International Conference on Malignant Lymphoma (ICML). Schedule your 30 min Free 1stOncology Demo! Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "Relapsed and refractory DLBCL remains one of the most difficult to treat lymphoid malignancies, with a uniformly poor prognosis, particularly for patients with refractory disease who are not eligible for high-dose chemotherapy or stem-cell transplantation." Mr. Weiss continued, "The data presented today by Dr. Lunning supports our belief that the combination of TG-1101 (ublituximab) and TGR-1202 (umbralisib), our ‘U2 regimen’, with bendamustine is a highly active and well tolerated treatment for patients with aggressive lymphomas. We are excited to be able to rapidly bring this combination forward in the DLBCL arm of our randomized registration-directed UNITY-NHL program and hope to be enrolling patients into this cohort before the end of the summer."
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Dr. Matthew Lunning, of the University of Nebraska Medical Center, stated, "I am extremely pleased with the durable responses seen with this novel triplet regimen, especially in patients with aggressive DLBCL who may not have been candidates for more intensive chemotherapy, transplantation, or CAR-T therapy, due to poor performance status or need for urgent therapy, a truly unmet medical need. Many patients had high-risk molecular features and some have obtained sustained responses. In addition to being highly active, the triplet regimen of U2-benda was very well tolerated, with a low incidence of Grade 3 or greater adverse events, particularly those that have been associated with the PI3K-delta class. I look forward to the possibility of testing this regimen earlier in relapsed and refractory DLBCL and am excited to see it advance into registration directed studies."
Highlights from today’s presentation include the following:
Poster Presentation: Combination of TGR-1202, Ublituximab, and Bendamustine is safe and highly active in patients with advanced DLBCL and Follicular Lymphoma (Abstract 277)
This poster presentation includes data from patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) treated with the triple combination of TG-1101 (ublituximab), TGR-1202 (umbralisib) and bendamustine. Thirty-three patients were evaluable for safety of which 24 were evaluable for efficacy (9 patients were note evaluable; 7 were too early to evaluate and 2 patients were off study prior to an efficacy assessment: 1 non-related adverse event (AE) and 1 investigator decision). The triple combination appears well tolerated with no discontinuations for a treatment related AE. No events of pneumonitis and no Grade 3/4 transaminitis were reported. Twenty-one patients (64%) were refractory to prior treatment. Mean time on study was approximately 6 months.
Efficacy highlights from this poster include:
100% (4 of 4) ORR, including a 50% CR rate, observed in patients with relapsed DLBCL
50% (6 of 12) ORR, including a 42% CR rate, observed in patients with refractory DLBCL with durable CR and PR responses observed (PR on-going for > 16+ months)
88% (7 of 8) ORR, including a 50% CR rate, observed in patients with relapsed or refractory FL
PRESENTATION DETAILS:
The above referenced presentation is now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.