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TG Therapeutics Announces Oral Presentation of Umbralisib, Ublituximab and Venetoclax Triple Combination Phase I/II Data in Relapsed/Refractory CLL at the 61st American Society of Hematology Annual Meeting and Exposition
100% overall response rate (ORR) in relapsed/refractory CLL patients treated with U2 (umbralisib + ublituximab) plus venetoclax at cycle 7 (n=13) 100% of
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"100% overall response rate (ORR) in relapsed/refractory CLL patients treated with U2 (umbralisib + ublituximab) plus venetoclax at cycle 7 (n=13)\n 100% of patients (n=9) achieved undetectable MRD in the peripheral blood after 12 months of therapy and 78% achieved undetectable MRD in bone marrow and have stopped all therapy No patients have progressed to date Investor and analyst event to be held on Monday, December 9, 2019 at 7:30 PM ET at the Hyatt Regency Orlando featuring a fireside chat with leading clinical investigators NEW YORK, Dec. 08, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced triple therapy data from the Phase I/II study of ublituximab (TG-1101), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with umbralisib (TGR-1202), the Company’s oral, dual inhibitor of PI3K delta and CK1 epsilon, and venetoclax, in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). Data from this trial were presented this morning during an oral session at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition. Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, “We are extremely pleased to share the first data from the triple combination of U2 (umbralisib and ublituximab) and venetoclax, which we believe has the potential to offer patients with CLL a highly active, time-limited, and generally well tolerated treatment option. It was exciting to see that for those patients followed for at least 12 months at the time of the presentation, there was a 100% ORR, and all of those patients achieved MRD negativity in the peripheral blood, with 7 of those 9 patients also achieving MRD negativity in the bone marrow. We look forward to updating these data at future conferences as more patients are followed for 12 months and longer.” Mr. Weiss continued, “We were also excited to see that 87% of patients responded to the U2 combination after just three months of treatment prior to the introduction of venetoclax. We believe this further demonstrates the activity of the U2 combination that is being studied in our UNITY-CLL Phase 3 trial, which we expect data from in the coming weeks or months.” Below are highlights from the oral presentation. Title: A Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in Patients with Relap...