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TG Therapeutics Announces Combination Data Presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL)

Published: 2021-09-20 11:30:00 ET

Investor & Analyst Virtual Event to Discuss Phase 1 U2 + Venetoclax Data to be held today, September 20, 2021 at 8:30 AM ET

NEW YORK, Sept. 20, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data presentations at the XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL). Data highlights from each presentation are included below.

The Company will also host a virtual investor and analyst event today, September 20, 2021 at 8:30 AM ET, to review the updated Phase 1 data evaluating the investigational combination of UKONIQ® (umbralisib) and ublituximab (U2) plus venetoclax presented at iwCLL, as well as provide an overview of the ULTRA-V Phase 2/3 trial.

Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “The iwCLL conference this past weekend was an exciting meeting, where we were able to share data from four combination trials, including updated data from our Phase 1/2 study of U2 plus venetoclax. Our goal has been to develop combination therapies utilizing U2 as a backbone and we believe the data presented this weekend showcase the breadth of the program, which includes combinations with targeted therapy as well as immunotherapy. With a March 25, 2022 PDUFA date in the US, we are excited about the potential approval of the U2 regimen for CLL patients and hope you all can join us this morning for our virtual event to review some of the encouraging data presented this past weekend.”

IwCLL 2021 DATA HIGHLIGHTSOral Presentation Title:Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study

421 patients were randomized to the U2 (n=210) or O+Chl (n=211) arms; 57% of patients were treatment-naïve and 43% had relapsed/refractory (R/R) CLL
At a median follow-up of 36.7 months, U2 significantly prolonged independent review committee (IRC) assessed progression-free survival (PFS) vs O+Chl (median 31.9 months vs 17.9 months; hazard ratio 0.546 (p20% of patients (n=20) include, neutropenia (45%), thrombocytopenia (15%), ALT increase (15%), leukopenia (10%), nausea (5%), fatigue (5%), and anemia (5%).
In this heavily pre-treated cohort with a median of 2 (1-9) prior lines of therapy: -- 91% ORR in patients with R/R CLL (n=11)-- 83% ORR in BTK refractory CLL patients (n=6), with 4 of 5 responders achieving a response to U2 alone at the patient’s first efficacy assessment, prior to the addition of pembrolizumab -- 25% ORR in patients with RT (n=8), including 25% CR rate

The above data presentations are available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.INVESTOR & ANALYST VIRTUAL EVENT INFORMATIONThe Company will host a virtual event today, September 20, 2021 at 8:30 AM ET, to discuss the updated Phase 1 data evaluating UKONIQ® (umbralisib) and ublituximab (U2) in combination with venetoclax in patients with CLL as well as provide an overview of the Phase 2/3 ULTRA-V program.

To attend the live event, please visit the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. Following the live event, an archive file will be available for replay, for a period of 30 days after the call.ABOUT U2 PLUS VENETOCLAX PHASE 1 TRIALThe Phase 1/2 trial, (NCT03379051), is a multi-center, dose-escalation trial designed to assess the safety and efficacy of UKONIQ and ublituximab (U2) plus venetoclax in patients with relapsed or refractory CLL. The primary objective of the trial is to evaluate the safety of venetoclax after U2 induction. The secondary objectives are clinical efficacy as defined by overall response rate (ORR), including complete response (CR) rate, progression-free survival (PFS), and undetectable minimal residual disease (uMRD) rate after 12 cycles of therapy. The trial enrolled approximately 50 CLL patients and is being led by Dr. Paul Barr of the Wilmot Cancer Institute, University of Rochester Medical Center.

ABOUT ULTRA-V PHASE 2 TRIALThe ULTRA-V Phase 2 trial, (NCT03801525), is an open-label, multicenter, trial designed to investigate the efficacy and safety of UKONIQ and ublituximab (U2) combined with venetoclax in subjects with CLL. The primary endpoint of the trial is overall response rate (ORR) and complete response (CR) rate. The trial enrolled approximately 165 patients with front-line and previously treated CLL at 26 sites throughout the United States.

ABOUT ULTRA-V PHASE 3 TRIALThe ULTRA-V Phase 3 trial is an open-label, multicenter, randomized controlled clinical trial comparing the time-limited triple combination of UKONIQ and ublituximab (U2) plus venetoclax, to an active control arm of continuous U2. The Phase 3 trial includes two independent randomized cohorts of CLL subjects: a treatment-naïve cohort and a previously treated cohort, with each cohort being enrolled and evaluated independently of each other. The primary endpoint for the trial is progression-free survival (PFS). This trial is being led by Richard R. Furman, MD, Director of CLL Research Center at Weill Cornell Medicine and targeting over 60 U.S. trial sites.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

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