Full Press Release Details
TG Therapeutics Announces Update Regarding UNITY-CLL Phase 3
Conference call to be held today, Tuesday, September 25, 2018 at
YORK, September 25, 2018 - TG Therapeutics (NASDAQ: TGTX) today
announced that the independent Data Safety Monitoring Board (DSMB)
for the UNITY-CLL Phase 3 trial met to review ongoing data from the
study and advised the Company that the interim analysis of Overall
Response Rate (ORR) could not be conducted at this time as the data
were not sufficiently mature to conduct the analysis. The DSMB did
not provide any further guidance but plans to meet quarterly over
the next year to continue to monitor the ongoing progress of the
trial. Given the uncertainty surrounding the timing and the outcome
of the ORR analysis, as well as the significant regulatory hurdles
associated with accelerated approval for CLL, the Company is now
guiding that it will focus on the primary endpoint of Progression
Free Survival (PFS) to support full approval of the ublituximab
plus umbralisib (U2) combination. At this time the Company is not
planning to seek accelerated approval based on ORR. The Company
remains blinded to all efficacy data.
the DSMB reviewed safety data from over 600 patients , including
over 300 patients treated with umbralisib either alone or in
combination with ublituximab, of which approximately 60% were
treatment na ve. While no evaluation of PFS was conducted, the
DSMB had PFS information available to them solely for purposes of
assessing the overall benefit-risk. After review of the data, the
DSMB identified no safety concerns and recommended the trial
continue without modification. The UNITY-CLL Phase 3 trial
continues to be conducted under Special Protocol Assessment (SPA)
agreement with the Food and Drug Administration (FDA).
S. Weiss, Executive Chairman and Chief Executive Officer of TG
Therapeutics stated, "While we are disappointed that we were not
able to report positive ORR today, we feel that making the decision
to focus on PFS, the primary endpoint for the study, is an
important step to getting everyone aligned on the endpoint of this
study that matters most to the Company and its long-term
shareholders. From a timing standpoint, we could have a PFS read
out in 2019, and we remain extremely optimistic about the prospects
for a successful PFS result. Other B-Cell Receptor antagonists have
shown dramatic improvements in PFS in similarly designed studies
and we believe the umbralisib early clinical data supports our
confidence in a positive PFS outcome from
Weiss continued, We now have 5 fully enrolled
registration-directed programs, including UNITY-CLL, UNITY-NHL
(including Follicular Lymphoma, Marginal Zone Lymphoma and Diffuse
Large B-cell Lymphoma cohorts) and the ULTIMATE Phase 3 MS program
and are awaiting pivotal data from all of them. With all of these
exciting data read-outs to come, we believe we remain well
positioned to deliver significant value for our
ABOUT UNITY-CLL PHASE 3 TRIAL
is a global Phase 3 randomized controlled clinical trial comparing
the combination of ublituximab plus umbralisib, or U2, to an active
control arm of obinutuzumab plus chlorambucil in patients with both
treatment na ve and relapsed or refractory Chronic Lymphocytic
Leukemia (CLL). The trial randomized patients into four treatment
arms: ublituximab single agent, umbralisib single agent,
ublituximab plus umbralisib and an active control arm of
obinutuzumab plus chlorambucil. A pre-specified analysis was
conducted to assess the contribution of ublituximab and umbralisib
in the combination regimen of ublituximab plus umbralisib and
allowed for the termination of the single agent arms. Accordingly,
the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratiointo
the two combination arms: the investigational arm of U2 and the
control arm of obinutuzumab plus chlorambucil. Full enrollment
into the UNITY-CLL Phase 3 trial completed in October of 2017. This
trial enrolled approximately 60% treatment na ve CLL patients
and 40% relapsed refractory CLL patients. The primary endpoint for
this study is to demonstrate superiority in Progression Free
Survival (PFS) for the U2 combination over the control arm to
support the submission for full approval of the U2 combination in
CLL. The UNITY-CLL Phase 3 trial is being conducted under Special
Protocol Assessment (SPA) agreement with the Food and Drug
Administration (FDA).
CONFERENCE CALL INFORMATION
Company will host a conference call today, Tuesday, September
25, 2018 at 8:30 am ET to discuss the UNITY-CLL Phase 3
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.
webcast of this presentation 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 TG THERAPEUTICS, INC.
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 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 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