UNITED STATES
SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D.C. 20549
_____________
FORM 8-K
_____________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of
1934
Date of report
(Date of earliest event reported): June 14, 2017
TG Therapeutics, Inc.
(Exact Name of
Registrant as Specified in Charter)
|
Delaware
(State or Other
Jurisdiction
of
Incorporation)
|
001-32639
(Commission File
Number)
|
36-3898269
(IRS Employer
Identification No.)
|
2 Gansevoort Street, 9th
Floor
New York, New York 10014
(Address of
Principal Executive Offices)
(212) 554-4484
(Registrant's
telephone number, including area code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
|
☐
|
Written communications pursuant to Rule 425
under the Securities Act.
|
|
☐
|
Soliciting material pursuant to Rule 14a-12
under the Exchange Act.
|
|
☐
|
Pre-commencement communications pursuant to Rule
14d-2b under the Exchange Act.
|
|
☐
|
Pre-commencement communications pursuant to Rule
13e-4(c) under the Exchange Act.
|
Indicate by check
mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (17 CFR
§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2). Emerging growth company
☐
If an emerging
growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On June 14, June
15, and June 16, 2017, TG Therapeutics, Inc. issued press releases
announcing certain data regarding its clinical studies of TGR-1202
plus ibrutinib, TG-1101 in combination with TGR-1202 and
bendamustine, TG-1101 plus ibrutinib (the GENUINE trial), and
TGR-1202 in combination with TG-1101 and ibrutinib, respectively,
at the 14th
International Conference on Malignant
Lymphoma (ICML), in Lugano, Switzerland. Copies of the press
releases are being filed as Exhibits 99.1, 99.2 and 99.3 and
incorporated in this Item by reference.
Item 9.01 Financial Statements And
Exhibits.
(d)
Exhibits.
99.1 Press
Release, dated June 14, 2017.
99.2 Press
Release, dated June 15, 2017.
99.3 Press
Release, dated June 16, 2017.
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
|
|
TG Therapeutics, Inc.
|
|
|
(Registrant)
|
|
|
|
|
|
|
|
|
|
|
Date: June 16,
2017
|
|
|
|
By: /s/
Sean A.
Power
|
|
|
Sean A.
Power
|
|
|
Chief Financial
Officer
|
|
|
|
INDEX
TO EXHIBITS
|
|
|
|
|
Exhibit
|
|
|
|
Number
|
|
Description
|
|
|
|
|
|
99.1
|
|
Press Release,
dated June 14, 2017.
|
|
|
|
|
|
99.2
|
|
Press Release, dated June 15,
2017.
|
|
|
|
|
|
99.3
|
|
Press Release, dated June 16,
2017.
|
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
TG Therapeutics, Inc. Announces
Follow-Up Data from the Triple Combination of TG-1101, TGR-1202,
and Bendamustine in Patients with DLBCL and FL at the
14th
International Conference on Malignant
Lymphoma
100% (4 of 4) ORR, including 50% CR rate in patients with relapsed
Diffuse Large B-Cell Lymphoma (DLBCL)
50% (6 of 12) ORR, including 42% CR rate in patients with chemo
and/or SCT refractory DLBCL
88% (7 of 8) ORR, including 50% CR rate in patients with relapsed
or refractory Follicular Lymphoma (FL)
The triple combination of TG-1101, TGR-1202 and bendamustine was
generally well-tolerated with the only Gr 3/4 event >10% being
neutropenia
NEW YORK, June 15, 2017-- TG Therapeutics, Inc. (NASDAQ: TGTX),
today announced updated clinical data from its Phase I/Ib trial of
TG-1101 (ublituximab), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody in combination with TGR-1202
(umbralisib), the Company’s oral, next generation PI3K delta
inhibitor, and bendamustine, in patients with Diffuse Large B-cell
Lymphoma (DLBCL) and Follicular Lymphoma (FL). Data from this trial
was presented today during a poster session at the
14th
International Conference on Malignant
Lymphoma (ICML).
Michael S. Weiss, the Company's Executive Chairman and Chief
Executive Officer stated, “Relapsed and refractory DLBCL
remains one of the most difficult to treat lymphoid malignancies,
with a uniformly poor prognosis, particularly for patients with
refractory disease who are not eligible for high-dose chemotherapy
or stem-cell transplantation.” Mr. Weiss continued,
“The data presented today by Dr. Lunning supports our belief
that the combination of TG-1101 (ublituximab) and TGR-1202
(umbralisib), our ‘U2 regimen’, with bendamustine is a
highly active and well tolerated treatment for patients with
aggressive lymphomas. We are excited to be able to rapidly bring
this combination forward in the DLBCL arm of our randomized
registration-directed UNITY-NHL program and hope to be enrolling
patients into this cohort before the end of the
summer.”
Dr. Matthew Lunning, of the University of Nebraska Medical Center,
stated, “I am extremely pleased with the durable responses
seen with this novel triplet regimen, especially in patients with
aggressive DLBCL who may not have been candidates for more
intensive chemotherapy, transplantation, or CAR-T therapy, due to
poor performance status or need for urgent therapy, a truly unmet
medical need. Many patients had high-risk molecular features
and some have obtained sustained responses. In addition to
being highly active, the triplet regimen of U2-benda was very well
tolerated, with a low incidence of Grade 3 or greater adverse
events, particularly those that have been associated with the
PI3K-delta class. I look forward to the possibility of
testing this regimen earlier in relapsed and refractory DLBCL and
am excited to see it advance into registration directed
studies.”
Highlights from today’s presentation include the
following:
Poster
Presentation: Combination of
TGR-1202, Ublituximab, and Bendamustine is safe and highly active
in patients with advanced DLBCL and Follicular Lymphoma (Abstract
277)
This
poster presentation includes data from patients with relapsed or
refractory Diffuse Large B-Cell Lymphoma (DLBCL) or Follicular
Lymphoma (FL) treated with the triple combination of TG-1101
(ublituximab), TGR-1202 (umbralisib) and bendamustine. Thirty-three
patients were evaluable for safety of which 24 were evaluable for
efficacy (9 patients were note evaluable; 7 were too early to
evaluate and 2 patients were off study prior to an efficacy
assessment: 1 non-related adverse event (AE) and 1 investigator
decision). The triple combination appears well tolerated with no
discontinuations for a treatment related AE. No events of
pneumonitis and no Grade 3/4 transaminitis were reported.
Twenty-one patients (64%) were refractory to prior treatment. Mean
time on study was approximately 6 months.
Efficacy highlights from this poster include:
●
100%
(4 of 4) ORR, including a 50% CR rate, observed in patients with
relapsed DLBCL
●
50%
(6 of 12) ORR, including a 42% CR rate, observed in patients with
refractory DLBCL with durable CR and PR responses observed (PR
on-going for >16+ months)
●
88%
(7 of 8) ORR, including a 50% CR rate, observed in patients with
relapsed or refractory FL
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 clinical trials; the risk that early clinical trial
results, including the safety and efficacy results seen with the
combination of TG-1101, TGR-1202 plus bendamustine 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
“U2”, and being studied in the triple combination of
TG-1101 plus TGR-1202 plus bendamustine 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 triple and/or quad therapies. 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
TG Therapeutics, Inc. Recaps Positive
Data from the Phase 3 GENUINE Trial and Data from the Triple
Combination of TG-1101, TGR-1202, and Ibrutinib at the
14th
International Conference on Malignant
Lymphoma
GENUINE Phase 3 trial met its primary endpoint with TG-1101
(ublituximab) plus ibrutinib increasing Overall Response Rate (ORR)
by >70% over ibrutinib alone in patients with high-risk
CLL
Triple combination of TG-1101, TGR-1202 and ibrutinib produced 100%
ORR (19 of 19) in patients with CLL/SLL, including 32% CR rate,
with a favorable safety profile observed
NEW YORK, June 16, 2017-- TG Therapeutics, Inc. (NASDAQ: TGTX),
today recapped clinical data from its Phase 3 GENUINE trial of
TG-1101 (ublituximab), the Company’s novel glycoengineered
anti-CD20 monoclonal antibody in combination with Ibrutinib, the
BTK inhibitor, as well as data from the chemo-free triple
combination of TGR-1202 (umbralisib), the Company’s oral,
next generation PI3K delta inhibitor, TG-1101, and ibrutinib. Data
from these trials were presented today during oral sessions at the
14th
International Conference on Malignant
Lymphoma (ICML) in Lugano, Switzerland. These data sets were
presented previously at the American Society of Clinical Oncology
(ASCO) annual meeting earlier this month. Highlights from each of
these data sets are included below.
Michael S. Weiss, the Company’s Executive Chairman and Chief
Executive Officer stated, “CLL patients with high-risk
cytogenetics continue to represent a challenge and continue to
progress more rapidly on ibrutinib than other patients. Improving
ibrutinib therapy for these hard to treat patients still represents
an unmet medical need. We are pleased to be the first Company to
demonstrate in a randomized Phase 3 trial an approach to
potentially improve outcomes for those patients. As presented today
at ICML, and last week at ASCO, the GENUINE Phase 3 trial showed
that by adding TG-1101 to ibrutinib, we could improve overall
response rate, CR rate, and MRD negativity in high risk patients.
We believe the data provide a compelling case for accelerated
approval given the demonstrated clinical benefit with limited
additional safety risk, and we look forward to sharing these data
formally with the FDA later this year.” Mr. Weiss continued,
“Additionally, at ICML today, and last week at ASCO, we had
an opportunity to present data on a triple therapy where we layered
our proprietary PI3K-delta inhibitor, TGR-1202, to the TG-1101 plus
Ibrutinib combination, and demonstrated even further enhanced
activity, with 100% ORR by iwCLL criteria and a high level of
complete responses. These data further confirm our approach of
building toward multi-drug regimens to enhance the outcome for
patients, ideally achieving CRs and avoiding lifelong therapy. We
look forward to continuing to explore unique combinations, with
TG-1101 (ublituximab) plus TGR-1202 (umbralisib) or
‘U2’ as the backbone.”
Highlights from today’s presentations include the
following:
Oral Presentation:
Ublituximab and ibrutinib for previously treated genetically
high-risk chronic lymphocytic leukemia: Results of the GENUINE
Phase 3 study (Abstract #101)
This
presentation includes data from the GENUINE Phase 3 trial, a
multicenter, randomized trial (NCT02301156), which assessed the
efficacy and safety of TG-1101 plus ibrutinib versus ibrutinib
alone in patients with high-risk CLL. For the trial, high-risk was defined as having any
one or more of the following centrally confirmed features: 17p
deletion, 11q deletion, or p53 mutation. The GENUINE study
was designed to demonstrate the value of adding TG-1101, a potent
next generation glycoengineered anti-CD20 monoclonal antibody to
ibrutinib monotherapy in high risk CLL, and was powered to show a
statistically significant improvement in ORR of 30%, with a minimal
absolute detectable difference between the two arms of
approximately 20%.
The
trial met its primary endpoint, demonstrating a statistically
significant improvement in Overall Response Rate (ORR), as assessed
by blinded independent central radiology and hematology review
by iwCLL (Hallek 2008) criteria, compared to ibrutinib alone in
both the Intent to Treat (ITT) population (p=0.001) and Treated
population (p<0.001). Per iwCLL guidelines, all responders
required confirmation of response for a minimum duration of 2
months. The ITT population includes all 126 randomized patients (64
in the TG-1101 plus ibrutinib arm and 62 in the ibrutinib alone
arm) while the Treated population includes all ITT patients that
received at least one dose of either study drug (59 in the TG-1101
plus ibrutinib arm and 58 in the ibrutinib alone arm).
Patient Demographics
One
hundred and twenty-six (126) patients were randomized on the
GENUINE Phase 3 Trial. 100% of patients were high risk and had
either 17p deletion, 11q deletion or p53 mutation. Sixty-four
percent (64%) of patients in the TG-1101 plus ibrutinib arm and 66%
of patients in the Ibrutinib alone arm had 17p deletion and/or a
p53 mutation while 36% and 34% of patients in the TG-1101 plus
ibrutinib and ibrutinib alone arms, respectively, had an 11q
deletion only. The median age of patients on either arm was 67
years and the median number of prior lines of therapy for either
arm was 3.
Safety & Tolerability
One hundred and seventeen (117) patients were evaluable for safety
(59 patients in the TG-1101 plus ibrutinib arm, and 58 patients in
the ibrutinib alone arm). The combination was well tolerated and,
apart from infusion related reactions, the addition of TG-1101 did
not appear to alter the safety profile of ibrutinib monotherapy.
Neutropenia, occurring in 9% of patients, was the most commonly
reported Grade 3/4 Adverse Event (AE) in the combination arm,
followed by infusion related reactions and anemia, each reported in
5% of patients. Notably, the majority of infusion related reactions
(IRR) were Grade 1 or 2 in severity, with only 5% Grade 3/4 IRR
observed. Median follow-up for this study was approximately 11.4
months.
Clinical Activity
Response Rates
|
|
TG-1101 plus
Ibrutinib
|
Ibrutinib
|
P-value
|
|
Treated Population
(n)
|
n=59
|
n=58
|
|
|
Overall Response
Rate (ORR)
|
78%
|
45%
|
P<0.001
|
|
Complete Response
(CR)
|
7%
|
0%
|
NS
|
|
MRD-Negative
|
19%
(n=53) *
|
2%
(n=53) *
|
P<0.01
|
*Patients evaluable for MRD included those enrolled >4 months
prior to data cutoff date of February 15, 2017. MRD analyzed by
central lab, 7-color flow cytometry
In
addition to the improvements in ORR, CR, and MRD-negativity, a
trend in improvement of Progression-Free Survival (PFS) in the
combination arm of TG-1101 plus ibrutinib as compared to ibrutinib
alone, however it was not statistically significant at the time of
the analysis.
ABOUT THE PHASE 3 GENUINE STUDY
The Phase 3 GENUINE study is a randomized, open label, multicenter
clinical trial to evaluate the safety and efficacy of TG-1101
(ublituximab) plus ibrutinib compared to ibrutinib alone in adult
patients with high risk Chronic Lymphocytic Leukemia (CLL) who
received at least one prior therapy for their disease.
The study was conducted at 160 clinical trial sites in the US and
Israel and randomized 126 patients. Patients received ibrutinib
orally at 420 mg once daily in both arms and in the treatment arm
those patients also received intravenous infusions of TG-1101 at
900 mg dosed on days 1, 8 and 15 of cycle 1 and day 1 of cycles
2-6. Patients in the treatment arm who had not progressed received
quarterly infusions of TG-1101 maintenance at 900 mg.
Oral Presentation:
Chemo-free triplet combination of TGR-1202, ublituximab, and
ibrutinib is well tolerated and highly active in patients with
advanced CLL and NHL (Abstract #102)
This oral presentation includes data from patients with Chronic
Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) and
Non-Hodgkin’s Lymphoma (NHL) treated with the triple
combination of TGR-1202, TG-1101 and ibrutinib. All patients were
relapsed or refractory to prior therapy, except 3 CLL patients who
were treatment naïve. Three cohorts for each CLL/SLL
and NHL were evaluated with TGR-1202 dose escalation
starting with doses of 400 mg (cohort 1), followed by 600 mg
(cohort 2) and 800 mg (cohort 3), in combination with TG-1101 at
900 mg and ibrutinib daily at 420 mg (CLL) and 560 mg
(NHL).
Safety & Tolerability
Thirty-eight (38) patients were evaluable for safety (20 CLL/SLL
patients, and 18 NHL patients). The triple combination appeared to
be well tolerated in all patients, with neutropenia (32% all
grades, 18% Grade 3/4) and pneumonia (18% all grades, 11% Grade
3/4), being the only Grade 3/4 AEs in >10% of patients. Of the
38 patients treated to date, only two AEs (sepsis and pneumonia)
led to treatment discontinuation. Median time on study was 11.1
months (range 0.4 – 30+ months) with 81% of patients on study
>6 months.
Clinical Activity
Clinical activity was observed at all dose levels with 36 of 38
patients evaluable for efficacy (19 CLL/SLL patients, and 17 NHL
patients), with 2 patients having discontinued prior to first
efficacy assessment (1 pneumonia, and 1 investigator
discretion).
CLL/SLL Efficacy highlights include:
●
100%
(19 of 19) Overall Response Rate (ORR), including a 32% Complete
Response (CR) rate observed in patients with CLL/SLL (4 of 6
CR’s pending bone marrow confirmation)
●
50%
of the CLL patients had a 17p and/or 11q deletion
●
3
CLL patients had prior BTK and/or PI3Kd inhibitor therapy,
including one patient refractory to both idelalisib and ibrutinib
who attained a complete response (ongoing for 1.5+
years)
NHL Efficacy highlights include:
●
Response
Rates observed in patients with NHL:
o
100%
(2 of 2) ORR, including one CR in patients with Marginal Zone
Lymphoma (MZL)
o
100%
(4 of 4) ORR, including 50% CR rate in patients with Mantle Cell
Lymphoma (MCL)
o
80%
(4 of 5) ORR, including 20% CR rate in patients with Follicular
Lymphoma (FL)
o
17%
(1 of 6) ORR in patients with Diffuse Large B-cell Lymphoma
(DLBCL)
●
FL
patients were heavily pretreated including 2 with prior Autologous
Stem Cell Transplant (ASCT), 1 refractory to prior ibrutinib, and 1
with 5 prior lines of rituximab based therapy
●
DLBCL
patients had a median of 4 prior therapies, and 4 of 6 were of
non-GCB subtype
PRESENTATION DETAILS:
The
above referenced presentations are 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: the risk that early clinical trial results, 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 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 triple and/or
quad therapies; the risk that even if the company is successful in
developing its drugs through FDA approval and on to the market,
that the cost efficiencies anticipated through proprietary
combinations may not be realized in the marketplace. 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