NEW YORK, Dec. 14, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced two data presentations, highlighted data from the UNITY-CLL Phase 3 trial evaluating the combination of ublituximab, the Company’s investigational anti-CD20 monoclonal antibody and UKONIQ (umbralisib), the Company’s inhibitor of PI3K-delta and CK1-epsilon, (U2), in patients with both treatment naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). Data presentations occurred yesterday evening during the 63rd American Society of Hematology (ASH) annual meeting and exposition. Presentation highlights are included below.

Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are pleased to share two presentations last night at the ASH annual meeting which included additional analyses of the UNITY-CLL Phase 3 trial evaluating the U2 combination in patients with both treatment naïve and relapsed or refractory CLL. We believe these presentations showcase the versatility of the U2 combination both by treatment subgroup, and also interestingly in a patient population generally characterized as unsuitable for BTKi-based therapy. While significant advances have been made in the treatment of CLL, there still remains underserved patients who may not be good candidates for or fail to respond to currently available treatments.”PRESENTATION HIGHLIGHTS

Poster Presentation Title: Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study

• A total of 210 CLL patients were enrolled in the U2 cohort of the UNITY-CLL trial, including 119 treatment naïve and 91 previously treated.
• Efficacy and safety highlights for the treatment naïve (TN) population included:
  • Independent review committee (IRC) assessed progression-free survival (PFS) of U2 in the TN population was 38.5 months, with two-year PFS of 76.6%
  • 84% IRC-assessed overall response rate (ORR) in the TN population, including 5% complete response (CR)/complete response with incomplete marrow recovery (CRi)
  • Responses were durable with 76% maintaining response at 2 years
  • Grade 3/4 adverse events (AEs) of special interest occurring in the TN population included ALT elevation (12%), AST elevation (8%), rash (3%), pneumonia (7%), non-infectious colitis (3%), pneumonitis (1%) and opportunistic infections (1%).
• Efficacy and safety highlights for the previously treated population (PT) included:
  • IRC-assessed PFS in the PT population was 19.5 months, with two-year PFS of 41.3%
  • 82% IRC-assessed ORR in the PT population, including 4% CR/CRi
  • Responses were durable, with 43% maintaining response at 2 years
  • Grade 3/4 adverse events (AEs) of special interest occurring in the PT population included ALT elevation (3%), AST elevation (2%), rash (1%), pneumonia (11%) and opportunistic infections (1%).

Poster Presentation Title: Favorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial

• A total of 210 CLL patients were enrolled in the U2 cohort of the UNITY-CLL trial, including 119 treatment naïve and 91 previously treated.
• 131 (64%) of U2 treated patients had at least 1 comorbid condition or concomitant medication (conmed) that could pose potential issues with BTKi therapy.
• 88% ORR, including 5% CR, for those patients with at least 1 comorbidity or conmed (n=131), compared to 83% ORR, including 5% CR, for the entire U2 population (n=210).
• No difference in IRC-assessed PFS was observed between the group of patients with at least 1 comorbidity or conmed compared to the entire U2 population (31.9 months for both groups).
• Grade 3/4s AEs of clinical interest in the group of patients with at least 1 comorbidity or conmed and the entire U2 population respectively, included ALT elevation (8%, 8%), AST elevation (4%, 5%), non-infectious colitis (3%, 2%) and pneumonitis (1%, 0.5%).

The above referenced presentations are now available on the Publications page of the Company’s corporate website at http://tgtxinc.com/publications.cfm.ABOUT TG THERAPEUTICS, INC.TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has three programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and Linkedin.UKONIQ® is a registered trademark of TG Therapeutics, Inc.ABOUT UKONIQ® (umbralisib) UKONIQ is the first and only oral inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon. PI3K-delta is known to play an important role in supporting cell proliferation and survival, cell differentiation, intercellular trafficking and immunity and is expressed in both normal and malignant B-cells. CK1-epsilon is a regulator of oncoprotein translation and has been implicated in the pathogenesis of cancer cells, including lymphoid malignancies. UKONIQ is indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen and for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. These indications are approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

IMPORTANT SAFETY INFORMATIONInfections: Serious, including fatal, infections occurred in patients treated with UKONIQ. Grade 3 or higher infections occurred in 10% of 335 patients, with fatal infections occurring in