NEW YORK, Sept. 23, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from an integrated safety analysis of UKONIQ® (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory lymphoid malignancies in Blood Advances, a journal of the American Society of Hematology. Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances. We believe these data further support the differentiated safety profile of UKONIQ, the first and only PI3k-delta and CK1-epsilon inhibitor, which is now commercially available to patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma. As we strive toward obtaining FDA approval of the investigational combination of UKONIQ and ublituximab, U2, in CLL by the PDUFA goal date of March 25, 2022, furthering our understanding of the safety and tolerability profile of UKONIQ remains paramount to us.”Matthew S. Davids, MD, MMSc, lead author of the integrated safety study and Director of Clinical Research in the Division of Lymphoma at Dana-Farber Cancer Institute stated, “Historically, the use of PI3K-delta inhibitors has been limited by high discontinuation rates. The integrated safety data analysis of umbralisib published [today/yesterday] is encouraging for patients, especially given the low rate of discontinuations due to adverse events observed. Our analysis further underscores the potential role of umbralisib in the treatment of relapsed or refractory marginal zone and follicular lymphoma and may support the future utilization of umbralisib in combination therapies for patients with lymphoid malignancies.”The manuscript includes integrated comprehensive toxicity data from 4 open-label phase 1 and 2 studies that included 371 adult patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients with follicular lymphoma (n=147), marginal zone lymphoma (n=81), diffuse large B-cell lymphoma/mantle cell lymphoma (n=74), chronic lymphocytic leukemia (n=43) and other (n=25). All patients were treated with umbralisib at 800mg or higher once daily. At data cutoff, median duration of umbralisib treatment was 5.9 months (range, 0.1-75.1), and 107 patients (28.8%) received umbralisib for ≥12 months.

Key highlights from this manuscript include:

• The most common grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (11.3%), diarrhea (7.3%), and increase aminotransferases (5.7%).
• AEs of special interest were limited and included pneumonia in 29 patients (7.8%), noninfectious colitis in 9 patients (2.4%), and pneumonitis in 4 patients (1.1%).
• Treatment-emergent serious AEs occurred in 95/371 patients (25.6%).
• AEs led to discontinuation of umbralisib in 51 patients (13.7%).
• No cumulative toxicity over time was observed.

These data are described further in the manuscript entitled, “Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies,” which was published online in Blood Advances. The online version of the article can be accessed at https://pubmed.ncbi.nlm.nih.gov/34547767/. 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 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