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EX-99.3 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v101617_ex993.htm |
EX-99.1 - EXHIBIT 99.1 - TG THERAPEUTICS, INC. | v101617_ex991.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v101617_8k.htm |
TG Therapeutics Announces Completion of Full Enrollment in
the UNITY-CLL Phase 3 Trial
Top-Line ORR data from the UNITY-CLL trial expected in
2Q18
Targeting an NDA/BLA filing for combination of TGR-1202 + TG-1101
in 2H18
NEW
YORK, October 16, 2017 - TG Therapeutics (NASDAQ: TGTX) announced
today that it has completed full enrollment in the UNITY-CLL Phase
3 clinical trial. The UNITY-CLL Phase 3 trial is a randomized study
of TG-1101 (ublituximab), the Company's novel glycoengineered
anti-CD20 monoclonal antibody, in combination with TGR-1202
(umbralisib), the Company's PI3K delta inhibitor (together referred
to as the U2 regimen), compared to an active control arm of
obinutuzumab plus chlorambucil, in patients with both treatment
naïve and relapsed or refractory Chronic Lymphocytic Leukemia
(CLL). The UNITY-CLL trial is being conducted under Special
Protocol Assessment (SPA) agreement with the Food and Drug
Administration (FDA).
Last
month, the Company announced that target enrollment of 175 patients
in each of the TG-1101 plus TGR-1202 and obinutuzumab plus
chlorambucil arms was achieved, however, enrollment was extended to
allow eligible patients who were already identified or in screening
the ability to participate in the study. Completion of full
enrollment has now been achieved with more than 200 patients in
each of the two combination arms. Approximately 60% of patients
enrolled in the combination arms were front-line and 40% were
previously-treated. As per the SPA, the primary and secondary
endpoint analyses will include all patients. Top-line Overall
Response Rate (ORR) data from the UNITY-CLL trial is expected in
the second quarter of 2018 and the company is targeting a New Drug
Application (NDA)/ Biologics License Application (BLA) filing for
the combination of TGR-1202 and TG-1101 in the second half of
2018.
Michael
S. Weiss, Executive Chairman and Chief Executive Officer, stated,
“We are pleased to report that UNITY-CLL has now completed
full enrollment, far exceeding the original targeted enrollment and
doing so much faster than anticipated. We believe the tremendous
demand for this study underscores the need for new treatment
options for CLL patients as well as the enthusiasm specifically for
the U2 regimen. Additionally, with the early completion of
UNITY-CLL, the potential filing timelines for GENUINE and UNITY-CLL
are now nearly overlapping, with a UNITY-CLL filing based on ORR
possible as early as 3Q18.” Mr. Weiss continued, “Our
goal is to extend quality life for patients with CLL by developing
efficacious treatments that are well-tolerated, easy to use and
don’t require harsh chemotherapy or hospital admission to
receive therapy. We believe U2 possesses these attributes and has
the potential to become one of the dominant treatment options for
first and second line CLL.”
ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL
is a global Phase 3 randomized controlled clinical trial in
patients with Chronic Lymphocytic Leukemia (CLL) that includes two
key objectives: first, was to demonstrate contribution of each
agent in the TG-1101 (ublituximab) + TGR-1202 (umbralisib) or U2
regimen, and second, to demonstrate superiority in Progression Free
Survival (PFS) over the standard of care to support the submission
for full approval of the combination. Inaddition, upon completion
of enrollment, this trial will evaluate Overall Response Rate (ORR)
for accelerated approval. The study initially randomized patients
into four treatment arms: TG-1101 plus TGR-1202, TG-1101 single
agent, TGR-1202 agent, and an active control arm of obinutuzumab
plus chlorambucil. Pursuant to the Special Protocol Assessment
(SPA) with the U.S. Food and Drug Administration (FDA),
an early interim analysis was conducted to assess contribution of
each single agent which allowed for early termination of both
single agent arms.
ABOUT TG THERAPEUTICS, INC.
TG
Therapeutics is a biopharmaceutical company focused on the
acquisition, development and commercialization of novel treatments
for B-cell malignancies and autoimmune diseases. Currently, the
company is developing two therapies targeting hematological
malignancies and autoimmune diseases. TG-1101 (ublituximab) is a
novel, glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on
matureB-lymphocytes. TG Therapeutics is also developing TGR-1202
(umbralisib), an orally available PI3K delta inhibitor. The delta
isoform of PI3K is strongly expressed in cells of hematopoietic
origin and is believed to be important in the proliferation and
survival of B‐lymphocytes. Both TG-1101 and TGR-1202, or the
combination of which is referred to as “U2”, are in
Phase 3 clinical development for patients with hematologic
malignancies, with TG-1101 also in Phase 3 clinical development for
Multiple Sclerosis. Additionally, the Company has recently brought
its anti-PD-L1 monoclonal antibody into Phase 1 development and
aims to bring additional pipeline assets into the clinic in the
future. TG Therapeutics is headquartered in New York
City.
Cautionary Statement
Some of
the statements included in this press release may be
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. 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 are the
following: our ability to successfully and cost effectively
complete the UNITY-CLL trial or deliver data on schedule as
planned; the risk that the combination of TG-1101 and TGR-1202,
referred to as TG-1303 or “U2”, and being studied in
the UNITY clinical trials, will not prove to be a safe and
efficacious combination treatment option for any indication; the
risk that UNITY-CLL does not demonstrate an ORR advantage or that
even if an ORR advantage is shown that the results do not support
accelerated approval; the risk that Unity-CLL will not demonstrate
a PFS advantage; the risk that safety issues or trends will be
observed in the UNITY-CLL study or any other on-going studies that
prevent approval of either TG-1101 and/or TGR-1202; the risk that
the UNITY-CLL study, or any of our other registration-directed
clinical trials as designed or amended may not be sufficient or
acceptable to support regulatory approval; the risk that a filing
based on UNITY-CLL, GENUINE or any other registration-direct trials
cannot be madeon schedule as targeted or at all; the risk that the
filing timelines for GENUINE and UNITY-CLL do not overlap or do not
occur at all; the risk that early clinical trial results, that may
have influenced our decision to proceed with additional clinical
trials, will not be reproduced in the final data presented; the
risk that the final data will not support regulatory approval. 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.
TGTX -
G
Jenna
Bosco
Vice President -
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com