On November 6, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that data for the triple combination of U2 (umbralisib and ublituximab) plus venetoclax has been accepted for oral presentation, and Phase 1 data for TG-1701, the Company’s novel BTK inhibitor, monotherapy and in combination with U2, has been accepted for poster presentation, at the upcoming 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting and exposition, to be held December 7 – 10, 2019, at the Orange County Convention Center in Orlando, FL (Press release, TG Therapeutics, NOV 6, 2019, View Source [SID1234550556]). Abstracts are now available online and can be accessed on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Abstract highlights and presentation details are outlined below.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, "We are looking forward to an exciting ASH (Free ASH Whitepaper) conference as we continue to present data highlighting the unique combinability of the U2 doublet as the backbone for triple therapy combinations. We believe the combination of U2 plus venetoclax offers a well-tolerated, highly-active, treatment option potentially offering CLL patients an opportunity to achieve bone marrow MRD negativity and cease treatment after 12 months." Mr. Weiss continued, "We are also extremely pleased to see the preliminary results for our BTK inhibitor, TG-1701, both as a single agent and in combination with U2. We have previously presented compelling results from the combination of U2 plus ibrutinib and believe a proprietary triplet can offer a better outcome for patients than U2 or a BTK alone, across multiple B-cell cancers. We look forward to sharing these data at the upcoming meeting as we continue to drive towards the initiation of our first NDA filing for umbralisib monotherapy, as well as the PFS readout for U2 from our UNITY-CLL Phase 3 trial."

Abstract Highlights

Oral Presentation: A Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Regimen was administered with 3 cycles of U2 induction to reduce risk of tumor lysis syndrome (TLS) followed by addition of venetoclax in cycle 4. Patients that were bone marrow MRD negative after cycle 12 were permitted to stop all therapy.
Overall response rate (ORR) of 85% (11/13) after U2 induction period, prior to introduction of venetoclax, in relapsed/refractory CLL patients, including patients refractory to ibrutinib
At the time of the abstract, 9 patients had been treated for >7 cycles and 5 patients for > 12 cycles:
◦ 100% ORR (9/9) after cycle 7 for the triple combination
◦ 100% (5/5) of patients who reached 12 cycles of therapy had undetectable minimal residual disease (MRD) (<0.01%) in peripheral blood; and
◦ 80% (4/5) of patients who reached 12 cycles of therapy had undetectable MRD in bone marrow and have stopped therapy
Triple combination was well tolerated with no events of TLS observed
Preliminary results suggest that the chemotherapy-free triple regimen of U2 plus venetoclax can provide undetectable MRD after only 12 cycles, representing an effective treatment plan for these heavily pre-treated CLL patients
Poster Presentation: Phase 1 Study of TG-1701, a Selective Irreversible Inhibitor of Bruton’s Tyrosine Kinase (BTK), in Patients with Relapsed/Refractory B-Cell Malignancies

TG-1701, a once daily BTK inhibitor, has an encouraging preliminary safety profile, with clinical and pharmacodynamic activity at all dose levels evaluated
19 patients have been treated with TG-1701: 3 patients at 100 mg QD, 9 patients at 200 mg QD (expansion before opening combination), 3 patients at 300 mg QD single agent arm, and 4 patients at 100 mg QD combination arm
All 3 patients treated with 100 mg TG-1701 plus U2 have achieved a response at the first response assessment: 1 Complete Response (CR) in a follicular lymphoma (FL) patient and 2 Partial Responses (PR), a FL patient with 88% reduction in tumor burden, and a marginal zone lymphoma (MZL) patient with 65% reduction in tumor burden
Presentation Details

Title: A Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
◦ Publication Number: 360
◦ Oral Session: 642. CLL: Therapy, excluding Transplantation: Combination and Novel Treatment
◦ Session Date and Time: Sunday, December 8, 2019; 7:30 AM – 9:00 AM ET
• Presentation Time: 8:45 AM ET
◦ Location: Orange County Convention Center, Hall E1
◦ Presenter: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY

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 each presentation, the data presented will be available on the Publications page of the Company’s website at View Source

TG THERAPEUTICS INVESTOR & ANALYST EVENT
TG Therapeutics will host an event on Monday, December 9, 2019 beginning at 7:30 PM ET with a featured fireside chat beginning promptly at 8:00 PM ET. The event will take place at the Hyatt Regency Orlando. A live webcast will be available on the Events page, located within the Investors & Media section of the Company’s website at View Source, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG TherapeuticsDecember 2019 Investor & Analyst Event.