Full Press Release Details
TG Therapeutics Announces Positive Results from the UNITY-NHL Phase
2b Pivotal Trial Evaluating Umbralisib Monotherapy in Patients with
Relapsed/Refractory Follicular Lymphoma
Follicular lymphoma cohort met the primary endpoint of overall
Umbralisib monotherapy appeared to be well tolerated with a safety
profile consistent with previous reports
TG plans to present the data at a future medical conference and
discuss the results with the FDA
Conference call to be held today, Monday, October 28, 2019 at 8:30
NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics,
Inc. (NASDAQ: TGTX), a biopharmaceutical company developing
medicines for patients with B-cell mediated diseases, today
announced that the follicular lymphoma (FL) cohort of the UNITY-NHL
Phase 2b pivotal trial evaluating single agent umbralisib, the
Company's novel, once daily, PI3K delta inhibitor, met the
primary endpoint of overall response rate (ORR) as determined by
Independent Review Committee (IRC) for all treated patients (n=118)
who have received at least two prior lines of therapy including an
anti-CD20 monoclonal antibody and an alkylating agent. The results
met the Company's prespecified ORR target of 40-50%.
Importantly, umbralisib monotherapy
appeared to be well tolerated with a safety profile consistent with
Company plans to present the data at a future medical conference as
well as discuss the data with the U.S. Food and Drug Administration
Michael S. Weiss, Executive Chairman and Chief Executive Officer of
TG Therapeutics stated, We are extremely pleased to announce
that the UNITY-NHL follicular lymphoma cohort evaluating umbralisib
monotherapy met the primary endpoint of ORR. There are no fully
approved drugs for patients with follicular lymphoma that have
progressed following two or more prior lines of therapy and we are
excited by the potential to offer a novel treatment for this
underserved population. We look forward to sharing
these results with the FDA and discussing submission opportunities
for accelerated approval of umbralisib in follicular lymphoma."
Mr. Weiss continued, These are
very exciting times for TG and with two additional major events
targeted to occur over the next several months, including
commencing our first NDA filing for
umbralisib in patients with relapsed/refractory marginal zone
lymphoma and results from our UNITY-CLL Phase 3 trial, we expect
that excitement to continue. Taken together, we see 2020 shaping up
as a pivotal year where we transition from a development-stage
company into a fully-integrated development and commercial
ABOUT THE UNITY-NHL PHASE 2b STUDY FOLLICULAR LYMPHOMA
The multicenter, open-label, UNITY-NHL Phase 2b study
Follicular Lymphoma cohort was designed to evaluate the safety and
efficacy of single agent umbralisib, the Company's
novel, once daily, PI3K delta inhibitor, in patients with FL who
have received at least two prior lines of therapy, including an
anti-CD20 regimen and an alkylating agent. The primary endpoint is
overall response rate (ORR) as determined by Independent Review
Committee (IRC) assessment. Secondary endpoints include safety,
duration of response, and progression-free survival
The positive ORR outcome announced today was based on 118 FL
patients that received at least one dose of umbralisib and who
previously had received at least two prior lines of therapy,
including an anti-CD20 regimen and an alkylating
CONFERENCE CALL INFORMATION
The Company will host a conference call today, Monday, October
28, 2019 at 8:30 AM ET to discuss the UNITY-NHL FL news. In
order to participate in the conference call, please call
1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.),
Conference Title: TG Therapeutics Update Call.
A live audio webcast of this call will be available on the Events
page, located within the Investors & Media section, of the
Company's website at www.tgtherapeutics.com.
An audio recording of the conference call will also be available
for replay at www.tgtherapeutics.com,
for a period of 30 days after the call.
ABOUT FOLLICULAR LYMPHOMA
Follicular lymphoma (FL) is typically a slow-growing or indolent
form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes,
making it a B-cell lymphoma. Follicular lymphoma is usually not
considered to be curable, and is a chronic disease. Patients can
live for many years with this form of lymphoma. With an annual
incidence in the United States of approximately 15,000 newly
diagnosed patients1,
FL is the most common indolent lymphoma accounting for
approximately 20 percent of all NHL cases2.
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. Ublituximab (TG-1101) is a
novel, glycoengineered monoclonal antibody that targets a specific
and unique epitope on the CD20 antigen found on mature
B-lymphocytes. TG Therapeutics is also developing
umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta.
Umbralisib uniquely inhibits CK1-epsilon, which may allow it to
overcome certain tolerability issues associated with first
generation PI3K-delta inhibitors. Both ublituximab and umbralisib,
or the combination of which is referred to as "U2", are in Phase 3
clinical development for patients with hematologic malignancies,
with ublituximab also in Phase 3 clinical development for Multiple
Sclerosis. Additionally, the Company has recently brought its
anti-PD-L1 monoclonal antibody, TG-1501, its covalently-bound
Bruton's Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as
its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1
development. TG Therapeutics is headquartered in New