Attached files
file | filename |
---|---|
EX-99.3 - EXHIBIT 99.3 - TG THERAPEUTICS, INC. | v061617_ex993.htm |
EX-99.2 - EXHIBIT 99.2 - TG THERAPEUTICS, INC. | v061517_ex992.htm |
8-K - 8-K - TG THERAPEUTICS, INC. | v061617_8k.htm |
TG Therapeutics, Inc. Announces
Follow-Up Data for Combination of TGR-1202 (umbralisib) plus
Ibrutinib in Patients with Relapsed or Refractory CLL and MCL at
the 14th
International Conference on Malignant
Lymphoma
Combination of TGR-1202 (umbralisib) plus ibrutinib appears well
tolerated with no Grade 3/4 transaminitis, pneumonitis, diarrhea,
or colitis observed, with longest patients on study 29.5+
months
94% of the CLL patients achieved a CR, PR or PR-L, including 1
patient with a CR, and 3 additional patients with radiographic
CR’s
79% ORR in patients with MCL, including 1 patient with a CR and 1
additional patient with a radiographic CR
NEW YORK, June 14, 2017-- TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced updated clinical data from its ongoing Phase I/Ib
trial of TGR-1202 (umbralisib), the Company’s oral, next
generation PI3K delta inhibitor, in combination with ibrutinib, a
BTK inhibitor, in patients with Chronic Lymphocytic Leukemia (CLL)
and Mantle Cell Lymphoma (MCL). This study is being run in
collaboration with the Blood Cancer Research
Partnership (BCRP) and Dana-Farber Cancer
Institute (DFCI), in Boston, MA. Data from this
trial were presented today by the Principal
Investigator, Matthew S. Davids, MD, of Dana-Farber
Cancer Institute, during an oral session at the
14th International
Conference on Malignant Lymphoma (ICML), in
Lugano, Switzerland.
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer stated, “We continue to be impressed with
the safety, tolerability and activity of the combination of
TGR-1202 and ibrutinib. With this all oral combination, we are
seeing high response rates, including in those patients with prior
PI3K inhibitor or ibrutinib exposure. Additionally, the combination
was well tolerated with over 30 patients now treated and for
durations upwards of 2.5 years in this independently run,
investigator initiated study.” Mr. Weiss continued, “We
want to thank Dr. Davids and his collaborators at DFCI
and the Leukemia & Lymphoma Society for leading this
important investigator driven research. Dr. Davids’ research
provides another important piece of information as we try to
identify the best way to use these drugs, alone or in combination.
These data complement the recently reported results at ASCO from
the triple combination of TGR-1202, ibrutinib and TG-1101, our
anti-CD20 monoclonal antibody, which showed that the three-drug
combination was also well-tolerated and appeared to induce even
higher rates of response, with 100% ORR by iwCLL criteria and
deeper responses with 26% of the CLL patients achieving a CR. We
look forward to continuing to explore these combinations to drive
better outcomes for patients.”
Highlights from today’s presentation include the
following:
Oral
Presentation: Updated results
of a multicenter phase I/Ib study of TGR-1202 in combination with
ibrutinib in patients with relapsed or refractory MCL or CLL
(Abstract #040)
This oral presentation includes data from patients with relapsed or
refractory Chronic Lymphocytic Leukemia (CLL) or Mantle Cell
Lymphoma (MCL) treated with TGR-1202 in combination with ibrutinib.
32 patients were evaluable for safety (18 CLL patients and 14 MCL
patients), of which 31 patients were available for efficacy (17 CLL
patients and 14 MCL patients). CLL patients had a median of 1.5
prior lines of therapy (range 1-6), with 2 patients receiving prior
ibrutinib and 4 receiving prior PI3K inhibitors. MCL patients
had a median of 3 prior lines of therapy (range 2-5), with 2
patients also receiving prior ibrutinib.
Highlights from this oral presentation include:
●
94%
(16 of 17) of CLL patients achieved a Complete Response (CR),
Partial Response (PR), or a Partial Response with lymphocytosis
(PR-L), with 1 patient achieving a CR and 3 additional patients
with radiographic CR
●
All
3 patients with prior PI3K inhibitor therapy that were evaluable
for efficacy, and 1 of the 2 patients with prior ibrutinib exposure
responded
●
1-year
progression free survival (PFS) for CLL is 88% and overall survival
(OS) at 1-year is 94%, (n=17), with the longest patient on study
29.5+ months
●
79%
(11/14) ORR in patients with MCL, including 1 CR and 1 additional
radiographic CR, with marked clinical benefit observed in two
additional patients
●
Median
PFS and OS for MCL is 8.4 and 11.6 months, respectively
(n=11)
●
The
combination appears well tolerated across all patients with no
grade 3/4 transaminitis (liver toxicity), diarrhea, colitis or
pneumonitis observed
PRESENTATION DETAILS:
The
above referenced presentation is now available on the Publications
page, located within the Pipeline section, of the Company’s
website at www.tgtherapeutics.com/publications.cfm.
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 mature
B-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 are in clinical development for patients with hematologic
malignancies, with TG-1101 also in 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.
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 preclinical and clinical trials; the risk that early
clinical trial results, including the safety and efficacy results
seen with the combination of TGR-1202 plus ibrutinib that may have
supported the acceptance of our data for presentation or influenced
our decision to proceed with additional clinical trials, will not
be reproduced in future studies; the risk that the combination of
TG-1101 and TGR-1202, referred to as TG-1303 or as the U2 regimen
and being studied in the chemo-free triple combination of TG-1101
plus TGR-1202 plus ibrutinib and in the UNITY clinical trials and
other combination trials, will not prove to be safe and efficacious
for any indication or as a backbone for current or future
combination trials. 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
CONTACT:
Jenna
Bosco
Vice President,
Investor Relations
TG Therapeutics,
Inc.
Telephone:
212.554.4351
Email: ir@tgtxinc.com