TG Therapeutics Announces Launch of the ULTRA-V Phase 3 Trial Evaluating the Triple Combination of UKONIQ (umbralisib), Ublituximab, and Venetoclax

ULTRA-V Phase 2 trial has reached completion of patient enrollment

NEW YORK, April 21, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the initiation of patient enrollment into the ULTRA-V Phase 3 randomized trial, evaluating the time-limited triple combination of UKONIQ (umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and CK1-epsilon, ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, and venetoclax, compared to the continuous doublet combination of UKONIQ plus ublituximab (U2) in patients with both frontline and relapsed or refractory chronic lymphocytic leukemia (CLL). The primary endpoint for the ULTRA-V Phase 3 trial is Progression-free Survival (PFS), and the trial is designed support the full approval of the triple combination of U2 plus venetoclax.

The Company also announced completion of enrollment into the ULTRA-V Phase 2 global, single arm trial evaluating the triple combination of U2 plus venetoclax. This primary endpoint for this trial is overall response rate (ORR) and complete response (CR) rate, and the trial completed enrollment with approximately 165 patients enrolled. The trial enrolled patients with front line CLL, as well as relapsed or refractory CLL, including patients who were refractory to prior Bruton’s Kinase Inhibitor (BTK) therapy.

Richard R. Furman, MD, Director of CLL Research Center at Weill Cornell Medicine and Study Chair for the ULTRA-V Phase 2 and Phase 3 trials stated, “We are excited to launch this pivotal Phase 3 study based on the promising Phase 1 clinical results reported to date on the triplet combination of UKONIQ, ublituximab and venetoclax in patients with CLL. While recent approvals provide excellent treatment options for patients, disease progression and treatment tolerability still remain problematic for many patients. Our belief is that time-limited treatment regimens, such as U2 plus venetoclax, have the potential to produce meaningful responses without the need to expose patients to continuous therapy and related toxicities. We look forward to presenting the results of the Phase 2 portion of this study at a future medical meeting. I want to thank my colleagues for their strong support of the Phase 2 ULTRA-V trial and look forward to continuing and expanding our efforts now in Phase 3.”