On December 8, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported 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) (Press release, TG Therapeutics, DEC 8, 2019, View Source [SID1234552039]). Data from this trial were presented this morning during an oral session at the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition.

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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) (<0.01%) in peripheral blood after 12 cycles of therapy; and
° 78% (7/9) of patients who completed 12 cycles of therapy had undetectable MRD in bone marrow and have stopped therapy
No patients (n = 27) have progressed to date with a median follow-up of 6.4 months
Triple combination was generally well tolerated with no events of TLS observed
An open-label, multicenter, Phase 2 study evaluating U2 plus venetoclax (ULTRA-V) in treatment naïve and previously treated CLL is now open for enrollment.

Remaining ASH (Free ASH Whitepaper) Presentation Details

Title: Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton’s Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies
° Publication Number: 4001
° Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
° Date and Time: Monday, December 9, 2019; 6:00 PM – 8:00 PM ET
° Location: Orange County Convention Center, Hall B
° Presenter: Chan Cheah, MD, Sir Charles Gairdner Hospital, Hollywood Private Hospital, University of Western Australia, Blood Cancer Research Western Australia
Following the presentation, the data presented will be available on the Publications page of the Company’s website at View Source