Full Press Release Details
Therapeutics, Inc. Amends the GENUINE Phase 3 Clinical Trial to
Accelerate Study Completion by Revising Primary Endpoint to Overall
FDA agrees that Overall Response Rate (ORR) data from revised
GENUINE study can be used to request pre-BLA (Biologics License
Application) meeting
of the revised GENUINE study are positive, the Company plans to
file a BLA for accelerated approval based on the outcome of the
Enrollment expected to be completed before year end 2016 with
top-line data available in first half of 2017
Amendments expected to save the Company more than $10 million over
the next 2 years, and allow the Company to focus its resources on
the UNITY-CLL program
Conference call to be held today, Thursday, October 13, 2016 at
York, NY, (October 13, 2016)
TG Therapeutics, Inc. (NASDAQ:TGTX) today announced that it
has filed with the FDA an amended protocol for the GENUINE Phase 3
trial. Prior to the amendments, the GENUINE study consisted of two
the effect of the addition of TG-1101 to ibrutinib on overall
response rate (ORR) in approximately the first 200 patients
enrolled, to support a filing for accelerated approval of TG-1101;
the effect of the addition of TG-1101 to ibrutinib on
progression-free survival (PFS) in all study patients
(approximately 330), to support a filing for full approval of
amended protocol contains the following substantive
study has been eliminated, and accordingly, the study's sole
primary endpoint will be ORR as originally contemplated in Part I;
has been reduced to approximately 120 randomized
new study size, the study is 90% powered to show a statistically
significant improvement in ORR, with the minimal detectable
difference of approximately 20% (absolute difference between the
arms). Additionally, patients will be followed until progression,
but the study will no longer be powered for PFS.
Company expects that it will complete enrollment in the revised
trial by year end 2016, and will have topline data available in the
first half of 2017. If the results of the study are positive, the
Company plans to request a pre-BLA meeting to discuss the data and
a filing strategy with the FDA. The Company has communicated with
the FDA regarding its intention to file a BLA for accelerated
approval if the results are positive and the FDA has agreed that a
pre-BLA meeting can be requested based on ORR data from the GENUINE
study. Assuming a positive outcome of a pre-BLA meeting, targeted
to occur in the fourth quarter of 2017, the Company believes it
could file a BLA in the first half of 2018.
S. Weiss, the Company's Executive Chairman and Interim Chief
Executive Officer, stated, Today's
announcement marks an important milestone for the Company. Given
the GENUINE enrollment challenges we've faced to date, we are
very excited to accelerate the trial to a rapid conclusion, while
also maintaining the ability to potentially file the data for
accelerated approval. The GENUINE study, as amended, remains a
robust, randomized clinical trial, which we believe, if positive,
could support accelerated approval for patients with
relapsed/refractory high-risk CLL. Moreover, we believe the amended
study and revised regulatory strategy is consistent with the recent
accelerated approvals for novel agents in CLL, which notably were
not pursuant to an SPA but occurred after the finding of positive
ORR results. Importantly, with completion of enrollment now
expected by year end, we and our clinical trial sites can focus our
resources on completing our UNITY-CLL Phase 3 trial as quickly as
possible. Early enrollment in UNITY-CLL is very encouraging and we
anticipate that study will be fully enrolled before filing a BLA
for the GENUINE study. UNITY-CLL remains unchanged and unaffected
by the amendments to the GENUINE study, and if positive, could
support full approval for both TG-1101 and TGR-1202 based on its
primary endpoint of PFS. Mr. Weiss continued, We have
greatly appreciated all of the guidance and counsel from the FDA in
designing our clinical programs and we look forward to continuing
our collaborative working relationship as we accelerate toward the
conclusion of enrollment into the GENUINE study this year and ORR
data in the first half of 2017."
Conference Call Information
Company will host a conference call today, Thursday, October 13,
2016 at 8:30am ET to
discuss the amendments to the GENUINE Phase 3 Trial.
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 GENUINE Update Call. A live
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
ABOUT TG THERAPEUTICS, INC.
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 mature B-lymphocytes. TG Therapeutics is
also developing 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 TG-1101 and
TGR-1202 are in clinical development for patients with hematologic
malignancies, with TG-1101 recently entering clinical development
for autoimmune disorders. The Company also has pre-clinical
programs to develop IRAK4 inhibitors, BET inhibitors, and
anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is
headquartered in New York City.