NEW YORK, March 09, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from the UNITY-NHL Phase 2b trial evaluating UKONIQ™ (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical Oncology (JCO).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased that the results of the UNITY-NHL trial which supported the recent approval of umbralisib, now called UKONIQ, in relapsed or refractory marginal zone and follicular lymphoma, have been published in the prestigious Journal of Clinical Oncology. The data published yesterday, and previously presented at the ASH 2020 conference, highlight the utility of UKONIQ across these diseases. As the first and only inhibitor of both PI3K-delta and CK1-epsilon, which is now commercially available, we believe UKONIQ offers an important new treatment option for patients.”

Pier Luigi Zinzani, MD, PhD, Professor, Institute of Hematology, “L. e A. Seràgnoli”, University of Bologna, and Global Chair of the UNITY-NHL Phase 2b study stated, “The data published yesterday as well as the recent U.S. FDA approval of umbralisib in relapsed or refractory marginal zone lymphoma and follicular lymphoma, are encouraging for patients suffering from these diseases, especially given the lack of a standard of care in these settings. As we see from the UNITY-NHL publication, umbralisib offers meaningful clinical activity across both marginal zone and follicular lymphoma and a manageable safety profile with relatively low rates of immune mediated toxicities and discontinuations due to adverse events.” The manuscript includes data from 208 patients with relapsed or refractory iNHL, including 69 marginal zone lymphoma (MZL), 117 follicular lymphoma (FL), and 22 small lymphocytic lymphoma (SLL) patients who were unresponsive to prior treatments (≥1 MZL; ≥2 FL/SLL), including anti-CD20–based therapy. Patients were administered umbralisib 800 mg orally once-daily until disease progression, unacceptable toxicity, or study withdrawal. The primary end point was overall-response-rate (ORR) as assessed by an independent review committee (IRC) based on the Lugano classification.

Key highlights from this manuscript include:

• The ORR was 47.1% across all relapsed or refractory iNHL patients treated (n=208)
• At a median follow-up of 27.8 months patients with relapsed or refractory MZL demonstrated:• 49.3% ORR with 16% Complete response (CR) rate (IRC assessed)• Median duration of response (DOR) was not reached (95% CI, 10.3 – not estimable) and• Median Progression Free Survival (PFS) was not reached (95% CI, 12.1 – not estimable)
• At a median follow-up of 27.5 months patients with relapsed or refractory FL demonstrated:• 45.3% ORR with 5.1% achieving a CR (IRC assessed)• Median DOR of 11.1 months (95% CI, 8.3–15.6)• Median PFS was 10.6 months
• Grade ≥3 treatment emergent adverse events (TEAEs) reported in ≥10% of patients included: neutropenia (11.5%) and diarrhea (10.1%). Increased ALT/AST (grade ≥3) occurred in 6.7%/7.2% of patients.
• Other AEs of special interest included pneumonitis (1.4%; grade >3 1.0%) and non-infectious colitis (1.9%; grade >3 0.5%).
• A total of 31 patients (14.9%) discontinued due to a treatment-related adverse event.

These data are described further in the manuscript entitled, “Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients with Relapsed/Refractory Indolent Lymphoma,” which was published online yesterday in the Journal of Clinical Oncology. The online version of the article can be accessed at https://ascopubs.org/doi/full/10.1200/JCO.20.03433.

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 UKONIQTM (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 two 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.

UKONIQTM 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