TG Therapeutics Announces Publication of Final Results from the Phase 3 GENUINE Trial Evaluating Ublituximab Plus Ibrutinib i...
February 23 2021 - 7:30AM
TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the
publication of final results from the Phase 3 GENUINE trial
evaluating ublituximab, the Company’s investigational
glycoengineered anti-CD20 monoclonal antibody, in combination with
ibrutinib, in patients with relapsed or refractory high-risk
chronic lymphocytic leukemia (CLL), in The Lancet Haematology.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “The Phase 3 data published yesterday,
and previously presented, demonstrated that the addition of
ublituximab to ibrutinib significantly improved overall response
rate, complete response rate as well as prolonged progression-free
survival. Significant unmet need still exists within the CLL
landscape, and patients with high-risk relapsed or refractory CLL
progress more rapidly than those without high-risk cytogenetics.
The outcome of the GENUINE study is therefore very encouraging, and
we believe these data are supportive of pursuing combination
strategies with ublituximab for high-risk CLL patients.” Mr. Weiss
continued, “We look forward to bringing ublituximab to market as
soon as possible as we pursue completion of a BLA submission with
the FDA in the first half of 2021 for the combination of
ublituximab plus umbralisib for patients with CLL.” Jeff P.
Sharman, MD, Director of Research at Willamette Valley Cancer
Institute and Medical Director of Hematology Research for The US
Oncology Network and Study Chair for the GENUINE trial stated, “The
utility of adding anti-CD20 therapy in combination with BTK
inhibitors, such as ibrutinib, has long been unclear with prior
studies using rituximab having failed to demonstrate an improvement
in long-term outcomes. These results published from the GENUINE
study are encouraging and may suggest that next generation
anti-CD20 antibodies could have value in combination approaches to
treating CLL.” The manuscript includes data from 126 patients with
relapsed or refractory high-risk CLL who were randomized on study,
of which 117 received at least one dose of treatment and were
included in safety analyses, with 59 receiving ublituximab plus
ibrutinib and 58 receiving ibrutinib monotherapy. Ibrutinib was
given orally daily at 420 mg for all cycles. Ublituximab was given
intravenously in 28-day cycles with up to 150 mg on day 1, 750 mg
on day 2, and 900 mg on days 8 and 15 of cycle 1, and continuing at
900 mg on day 1 of cycles 2 through 6. Beyond cycle 6, ublituximab
was given at 900 mg every 3 months. Ublituximab and ibrutinib were
continued until unacceptable toxicity, disease progression, or
withdrawn consent. The primary endpoint was independent review
committee (IRC) assessed overall response rate (ORR) per iwCLL 2008
criteria. Key highlights from this manuscript include:
- The IRC-assessed ORR among treated
patients was 90% (53 of 59) in the ublituximab-ibrutinib arm and
69% (40 of 58) in the ibrutinib arm (p=0.0060), with a CR/CRi rate
of 20% (12 of 59) and 5% (3 of 58), respectively (p=0.024).
- After a median follow-up of 41.6
months, median IRC-assessed progression-free survival (PFS) in all
treated patients was not reached in the ublituximab-ibrutinib
group (95% CI, not estimable [NE]) after 15 PFS events and 35.9
months (95% CI, 17·0-NE) in the ibrutinib group after 25 PFS events
(hazard ratio [HR], 0.46; 95% CI, 0.24-0.87).
- The most common grade 3/4 adverse
events in the ublituximab-ibrutinib group and the ibrutinib group
were neutropenia (19%; 12%), anaemia (8%; 9%), and diarrhea (10%;
5%).
These data are described further in the manuscript entitled, “A
Phase 3, Randomized Trial of Ublituximab Plus Ibrutinib for
Patients With Relapsed/Refractory High-Risk Chronic Lymphocytic
Leukaemia,” which was published [online yesterday] in The Lancet
Haematology. The online version of the article can be accessed at
https://www.thelancet.com/journals/lanhae/home.ABOUT TG
THERAPEUTICS, INC. TG Therapeutics is a
fully-integrated, commercial stage biopharmaceutical company
focused on the acquisition, development and commercialization of
novel treatments for B-cell malignancies and autoimmune diseases.
In addition to an active research pipeline including five
investigational medicines across these therapeutic areas, TG has
received accelerated approval from the U.S. FDA for
UKONIQ™ (umbralisib), for the treatment of adult patients with
relapsed/refractory marginal zone lymphoma who have received at
least one prior anti-CD20-based regimen and relapsed/refractory
follicular lymphoma who have received at least three prior lines of
systemic therapies. Currently, the Company has two programs in
Phase 3 development for the treatment of patients with relapsing
forms of multiple sclerosis (RMS) and patients with chronic
lymphocytic leukemia (CLL) and several investigational medicines in
Phase 1 clinical development. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and Linkedin.UKONIQ™ is a
registered trademark of TG Therapeutics,
Inc.Cautionary StatementThis press release
contains forward-looking statements that involve a number of risks
and uncertainties. For those statements, we claim the protection of
the safe harbor for forward-looking statements contained in the
Private Securities Litigation Reform Act of 1995.
Such forward looking statements include but are not limited to
statements regarding expectations for the timing of the Company’s
BLA submission for ublituximab in combination with umbralisib for
the treatment of CLL and our research and development program
evaluating ublituximab in different combinations in CLL. In
addition to the risk factors identified from time to time in our
reports filed with the Securities and Exchange Commission,
factors that could cause our actual results to differ materially
include the following: the Company’s ability to complete the BLA
submission for ublituximab in combination with umbralisib for the
treatment of CLL within the projected timeframe or at all;
regulatory challenges that prevent the FDA from accepting the
ublituximab BLA submission or, if the submission is accepted,
prevent the FDA from approving the BLA; the risk that clinical
trial results (both safety and efficacy), that may have supported
the acceptance of our data for presentation or publication or
influenced our decision to proceed with additional clinical trials,
will not be reproduced in ongoing and future clinical studies,
including in the ongoing and planned studies evaluating ublituximab
in different combination regimens in CLL; the risk that the GENUINE
study will not be utilized for any regulatory submission, or
support any regulatory approvals for ublituximab; the uncertainties
inherent in research and development; and the risk that the ongoing
COVID-19 pandemic and associated government control measures have
an adverse impact on our research and development plans or
commercialization efforts. Further discussion about these and other
risks and uncertainties can be found in our Annual Report on Form
10-K for the fiscal year ended December 31, 2019 and in
our other filings with the U.S. Securities and Exchange
Commission.
Any forward-looking statements set forth in this press release
speak only as of the date of this press release. We do not
undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
This press release and prior releases are available
at www.tgtherapeutics.com. The information found on our
website is not incorporated by reference into this press release
and is included for reference purposes only.
CONTACT: |
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Jenna Bosco |
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Senior Vice President, |
|
Corporate Communications |
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TG Therapeutics, Inc. |
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Telephone: 1.877.575.TGTX (8489) |
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Email: ir@tgtxinc.com |
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