On December 4, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported updated clinical data from its Phase I/Ib trial of ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody in combination with umbralisib (TGR-1202), 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, DEC 4, 2018, View Source [SID1234532244]). Data from this trial was presented yesterday evening during a poster session at the 60thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.
Schedule your 30 min Free 1stOncology Demo!
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, the Company’s Executive Chairman and Chief Executive Officer stated, "The data presented yesterday further supports our belief that our proprietary U2 combination is an ideal backbone regimen on which to build novel multi-drug combinations. The triple therapy of U2 plus bendamustine is highly active and well tolerated in advanced patients, resulting in durable responses with some patients on study 36+ months." Mr. Weiss continued, "We are looking forward to an exciting 2019, with pivotal data expected from the ongoing UNITY-NHL registration directed program in the first half of the year."
Below summarizes the data from the poster presentation.
Combination of Umbralisib, Ublituximab, and Bendamustine is Safe and Highly Active in Patients with Advanced DLBCL and Follicular Lymphoma (Abstract 4197)
This poster presentation includes data from patients with relapsed or refractory DLBCL or FL treated with the triple combination of umbralisib, ublituximab and bendamustine. Thirty-nine patients were evaluable for safety of which 38 were evaluable for efficacy (one patient discontinued due to a treatment-related adverse event (AE), neutropenia, prior to first efficacy assessment). Twenty-two patients (56%) were refractory to prior treatment. Overall, the triple combination was well tolerated and highly active in patients with advanced indolent and aggressive NHL, including those not eligible for HD/SCT or CD19 CART therapy.
Efficacy highlights from this poster include:
85% (11 of 13) ORR, including a 54% CR rate, observed in patients with relapsed or refractory FL
48% (12 of 25) ORR, including a 36% CR rate, observed in patients with relapsed or refractory DLBCL
PRESENTATION DETAILS:
The above referenced presentation is available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.