TG Therapeutics Announces Data from a Phase 1 Study Evaluating TG-1701 as a Monotherapy and as a Triple Combination with Ublituximab and UKONIQ® at the 2021 American Society of Clinical Oncology Annual Meeting
100% ORR in CLL patients treated with 300 mg QD of TG-1701 monotherapy (n=19)
Triple combination of ublituximab and UKONIQ (U2) + TG-1701 cohort (n=19) resulted in 79% ORR, with 21% CR rate, including 100% ORR in patients WM, CLL, MZL, MCL, and DLBCL (n=11)
NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data from TG-1701, the Company’s investigational once-daily, oral BTK inhibitor, as a monotherapy and as a triple therapy in combination with ublituximab, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ® (umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Data from this trial were made available on demand this morning during the American Society of Clinical Oncology (ASCO) Annual Meeting. Presentation highlights are included below.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, “We are pleased to see that with additional patients and longer follow-up, TG-1701, our BTK inhibitor, continues to show encouraging clinical activity paired with what appears to be a tolerable safety profile, especially in the triple combination with U2. It is also exciting to see some early complete responses in patients treated with the triple therapy. We look forward to continuing to enroll on this trial and presenting additional data.”
Data presented at ASCO 2021 is available on the Publications page of the Company’s website at https://www.tgtherapeutics.com/publications/.
UKONIQ® is a registered trademark of TG Therapeutics, Inc.
ABOUT UKONIQ® (umbralisib)
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 INFORMATION
In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: the risk that interim, top-line, or other early clinical trial results, including the clinical studies evaluating TG-1701 in combination with U2, will not be reproduced in final data sets or in future studies; the risk that the safety profile observed with TG-1701 as monotherapy and in combination with U2, may change as additional patients are exposed for longer durations; the risk that TG-1701 as monotherapy or in combination with U2 will not prove to be safe and efficacious; the uncertainties inherent in research and development; and the risk that the ongoing COVID-19 pandemic has an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, and in our other filings with the U.S. Securities and Exchange Commission.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
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