100% overall response rate (ORR) in relapsed/refractory CLL patients (n=9) treated with U2 (umbralisib + ublituximab) plus venetoclax, with all patients at 12 months achieving MRD negativity (n=5)

Proprietary triplet of U2 plus TG-1701 (BTK inhibitor) induced 100% ORR (n=3) in patients with relapsed/refractory marginal zone lymphoma and follicular lymphoma at the lowest dose of TG-1701 tested

Additional patients and updated data will be presented at the conference

Investor and analyst event to be held on Monday, December 9, 2019 at 7:30 PM ET at the Hyatt Regency Orlando featuring a fireside chat with leading clinical investigators

NEW YORK, Nov. 06, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that data for the triple combination of U2 (umbralisib and ublituximab) plus venetoclax has been accepted for oral presentation, and Phase 1 data for TG-1701, the Company’s novel BTK  inhibitor, monotherapy and in combination with U2, has been accepted for poster presentation, at the upcoming 61st American Society of Hematology (ASH) annual meeting and exposition, to be held December 7 – 10, 2019, at the Orange County Convention Center in Orlando, FL. Abstracts are now available online and can be accessed on the ASH meeting website at www.hematology.org. Abstract highlights and presentation details are outlined below.

Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, “We are looking forward to an exciting ASH conference as we continue to present data highlighting the unique combinability of the U2 doublet as the backbone for triple therapy combinations. We believe the combination of U2 plus venetoclax offers a well-tolerated, highly-active, treatment option potentially offering CLL patients an opportunity to achieve bone marrow MRD negativity and cease treatment after 12 months.”  Mr. Weiss continued, “We are also extremely pleased to see the preliminary results for our BTK inhibitor, TG-1701, both as a single agent and in combination with U2. We have previously presented compelling results from the combination of U2 plus ibrutinib and believe a proprietary triplet can offer a better outcome for patients than U2 or a BTK alone, across multiple B-cell cancers. We look forward to sharing these data at the upcoming meeting as we continue to drive towards the initiation of our first NDA filing for umbralisib monotherapy, as well as the PFS readout for U2 from our UNITY-CLL Phase 3 trial.”

Abstract Highlights

Oral Presentation: A Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

• Regimen was administered with 3 cycles of U2 induction to reduce risk of tumor lysis syndrome (TLS) followed by addition of venetoclax in cycle 4. Patients that were bone marrow MRD negative after cycle 12 were permitted to stop all therapy.
• Overall response rate (ORR) of 85% (11/13) after U2 induction period, prior to introduction of venetoclax, in relapsed/refractory CLL patients, including patients refractory to ibrutinib
• At the time of the abstract, 9 patients had been treated for >7 cycles and 5 patients for > 12 cycles:◦  100% ORR (9/9) after cycle 7 for the triple combination◦  100% (5/5) of patients who reached 12 cycles of therapy had undetectable minimal residual disease (MRD) (