Full Press Release Details
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
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
YORK, NY (December 8, 2019) - 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
American Society of Hematology (ASH) Annual Meeting and
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.
are highlights from the oral presentation.
Phase 1/2 Study of Umbralisib, Ublituximab and Venetoclax in
Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia
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
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
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
U2 induction appeared to reduce venetoclax TLS risk, with no
patients remaining as TLS high-risk following 3 cycles of
13 patients treated for >7 cycles and 9 patients for
100% ORR (13/13) after cycle 7 for the triple
100% ORR (9/9) including 44% Complete Response (CR) after cycle 12
100% (9/9) of patients had undetectable minimal residual disease
(MRD) (<0.01%) in peripheral blood after 12 cycles of therapy;
78% (7/9) of patients who completed 12 cycles of therapy had
undetectable MRD in bone marrow and have stopped
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
open-label, multicenter, Phase 2 study evaluating U2 plus
venetoclax (ULTRA-V) in treatment na ve and previously treated
CLL is now open for enrollment.
Remaining ASH 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
Session: 623. Mantle Cell,
Follicular, and Other Indolent B-Cell Lymphoma Clinical
Date and Time: Monday, December
9, 2019; 6:00 PM - 8:00 PM ET
Location: Orange County
Convention Center, Hall B
Presenter: Chan Cheah,
Charles Gairdner Hospital, Hollywood Private Hospital, University
of Western Australia, Blood Cancer Research Western
the presentation, the data presented will be available on the
Publications page of the Company's website at https://www.tgtherapeutics.com/publications/.
TG THERAPEUTICS INVESTOR & ANALYST EVENT
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, in the Plaza International Ballroom I. A live
webcast will be available on the Events page, located within the
Investors & Media section of the Company's website at
http://ir.tgtherapeutics.com/events, 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 Therapeutics December 2019 Investor & Analyst
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments