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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)
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"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.” PRESENTATION HIGHLIGHTS: Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Chronic Lymphocytic Leukemia (CLL) and Lymphoma A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or TG-1701 in combination with U2 in the dose escalation cohort (n=19).TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD.Adverse Events (AEs) of special interest in patients treated with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3 hypertension (4.9%), atrial fibrillation (1.2%), and no instances of major bleeding ob...