100% overall response rate (ORR) in relapsed/refractory CLL patients treated with U2 (umbralisib + ublituximab) plus venetoclax at cycle 7 (n=13)

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 Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

This oral presentation includes data from patients with relapsed or refractory CLL treated with the triple combination of ublituximab, umbralisib, and venetoclax. Twenty-seven patients were evaluable for safety and 23 were evaluable for efficacy. Data highlights include:

• Regimen was administered with 3 cycles of U2 induction/debulking to reduce the risk of tumor lysis syndrome (TLS), followed by the combination of umbralisib and venetoclax starting in cycle 4. Patients who were bone marrow MRD negative after cycle 12 stopped all therapy.
• Overall response rate (ORR) of 87% (20/23) after U2 induction period at cycle 3, prior to introduction of venetoclax, in relapsed/refractory CLL patients, including patients refractory to ibrutinib
• U2 induction appeared to reduce venetoclax TLS risk, with no patients remaining as TLS high-risk following 3 cycles of U2
• 13 patients treated for >7 cycles and 9 patients for > 12 cycles: °  100% ORR (13/13) after cycle 7 for the triple combination °  100% ORR (9/9) including 44% Complete Response (CR) after cycle 12 for the combination°  100% (9/9) of patients had undetectable minimal residual disease (MRD) (