Benzinga | Jun 11, 2021 07:01AM EDT

TG Therapeutics Reports Data From Phase 1 Study Of TG-1701 As Monotherapy, Triple Combo With Ublituximab, UKONIQ At European Hematology Association Virtual Congress

TG Therapeutics, Inc. (NASDAQ:TGTX), today announced data from TG-1701, the Company's investigational once-daily, oral BTK inhibitor, as a monotherapy and as a triple therapy in combination with ublituximab, the Company's novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ(r) (umbralisib), the Company's once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Data from this trial were made available on demand this morning during the 3032 European Hematology Association (EHA) Virtual Congress. The data presented today were previously presented at the American Society of Clinical Oncology (ASCO) annual meeting.

PRESENTATION HIGHLIGHTS:

Poster Presentation Title TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma

* A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or TG-1701 in combination with U2 in the dose escalation cohort (n=19).

* TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD.

* Adverse Events (AEs) of special interest in patients treated with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3 hypertension (4.9%), atrial fibrillation (1.2%), and no instances of major bleeding observed. Grade 3 AEs occurring in ?10% of patients treated with U2+1701 included diarrhea (11%), neutropenia (11%), ALT increase (16%), and AST increase (16%), and Grade 4 AEs occurring in ?10% of patients treated with U2+1701 included neutropenia (11%).

* At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates (ORR) were: 95% (19/20) in CLL, 65% (13/20) in mantle cell lymphoma (MCL), and 95% (19/20) in Waldenstrom macroglobulinemia (WM).

* 100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort (n=19).

* At a median follow up of 15.6 months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=19).

Data presented at EHA 2021 is available on the Publications page of the Company's website at https://www.tgtherapeutics.com/publications/.