TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data from
TG-1701, the Company’s investigational once-daily, oral BTK
inhibitor, as a monotherapy and as a triple therapy in combination
with ublituximab, the Company’s novel glycoengineered anti-CD20
monoclonal antibody, and UKONIQ® (umbralisib), the Company’s
once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients
with front line or relapsed/refractory non-Hodgkin’s lymphoma (NHL)
and chronic lymphocytic leukemia (CLL). Data from this trial were
made available on demand this morning during the 3032 European
Hematology Association (EHA) Virtual Congress. The data presented
today were previously presented at the American Society of Clinical
Oncology (ASCO) annual meeting.
PRESENTATION HIGHLIGHTS:
Poster Presentation Title:
TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as
Monotherapy and in Combination with Ublituximab and Umbralisib (U2)
in Chronic Lymphocytic Leukemia (CLL) and Lymphoma
- A total of 125 patients with R/R
CLL or B-cell lymphoma have been treated with TG-1701, with
patients receiving monotherapy in the dose-escalation cohort
(n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL
dose-expansion cohort (n=20), or TG-1701 in combination with U2 in
the dose escalation cohort (n=19).
- TG-1701 monotherapy was well
tolerated and the maximum tolerated dose was not reached up to 400
mg QD.
- Adverse Events (AEs) of special
interest in patients treated with 200 mg and 300 mg QD of TG-1701
(n=81), included Grade 3 hypertension (4.9%), atrial fibrillation
(1.2%), and no instances of major bleeding observed. Grade 3 AEs
occurring in ≥10% of patients treated with U2+1701 included
diarrhea (11%), neutropenia (11%), ALT increase (16%), and AST
increase (16%), and Grade 4 AEs occurring in ≥10% of patients
treated with U2+1701 included neutropenia (11%).
- At a median follow up of 12.2
months in the 200 mg QD monotherapy expansion cohorts, overall
response rates (ORR) were: 95% (19/20) in CLL, 65% (13/20) in
mantle cell lymphoma (MCL), and 95% (19/20) in Waldenstrom
macroglobulinemia (WM).
- 100% ORR observed at a median
follow up of 8.6 months in the 300 mg CLL monotherapy cohort
(n=19).
- At a median follow up of 15.6
months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg
QD of TG-1701) resulted in 79% ORR, with 21% CR rate across
patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large
B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=19).
Data presented at EHA 2021 is available on the
Publications page of the Company’s website
at https://www.tgtherapeutics.com/publications/.ABOUT
TG THERAPEUTICS, INC.TG Therapeutics is a
fully-integrated, commercial stage biopharmaceutical company
focused on the acquisition, development and commercialization of
novel treatments for B-cell malignancies and autoimmune diseases.
In addition to an active research pipeline including five
investigational medicines across these therapeutic areas, TG has
received accelerated approval from the U.S. FDA for
UKONIQ® (umbralisib), for the treatment of adult patients with
relapsed/refractory marginal zone lymphoma who have received at
least one prior anti-CD20-based regimen and relapsed/refractory
follicular lymphoma who have received at least three prior lines of
systemic therapies. Currently, the Company has three programs in
Phase 3 development for the treatment of patients with relapsing
forms of multiple sclerosis (RMS) and patients with chronic
lymphocytic leukemia (CLL) and several investigational medicines in
Phase 1 clinical development. For more information,
visit www.tgtherapeutics.com, and follow us on
Twitter @TGTherapeutics and Linkedin.UKONIQ® is a
registered trademark of TG Therapeutics, Inc.
ABOUT
UKONIQ® (umbralisib) UKONIQ is the
first and only oral inhibitor of phosphoinositide 3 kinase
(PI3K) delta and casein kinase 1 (CK1) epsilon.
PI3K-delta is known to play an important role in supporting
cell proliferation and survival, cell differentiation,
intercellular trafficking and immunity and is expressed in both
normal and malignant B-cells. CK1-epsilon is a regulator of
oncoprotein translation and has been implicated in the pathogenesis
of cancer cells, including lymphoid malignancies.
UKONIQ is indicated for the treatment of adult
patients with relapsed or refractory marginal zone lymphoma (MZL)
who have received at least one prior anti-CD20-based regimen and
for the treatment of adult patients with relapsed or refractory
follicular lymphoma (FL) who have received at least three prior
lines of systemic therapy.
These indications are approved under accelerated
approval based on overall response rate. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in a confirmatory trial.
IMPORTANT SAFETY
INFORMATIONInfections: Serious, including
fatal, infections occurred in patients treated with UKONIQ. Grade 3
or higher infections occurred in 10% of 335 patients, with fatal
infections occurring in <1% . The most frequent Grade ≥3
infections included pneumonia, sepsis, and urinary tract infection.
Provide prophylaxis for Pneumocystis jirovecii pneumonia (PJP) and
consider prophylactic antivirals during treatment with UKONIQ to
prevent CMV infection, including CMV reactivation. Monitor for any
new or worsening signs and symptoms of infection, including
suspected PJP or CMV, during treatment with UKONIQ. For Grade 3 or
4 infection, withhold UKONIQ until infection has resolved. Resume
UKONIQ at the same or a reduced dose. Withhold UKONIQ in patients
with suspected PJP of any grade and permanently discontinue in
patients with confirmed PJP. For clinical CMV infection or viremia,
withhold UKONIQ until infection or viremia resolves. If UKONIQ is
resumed, administer the same or reduced dose and monitor patients
for CMV reactivation by PCR or antigen test at least
monthly.Neutropenia: Serious neutropenia occurred
in patients treated with UKONIQ. Grade 3 neutropenia developed in
9% of 335 patients and Grade 4 neutropenia developed in 9%. Monitor
neutrophil counts at least every 2 weeks for the first 2 months of
UKONIQ and at least weekly in patients with neutrophil count <1
x 109/L (Grade 3-4) neutropenia during treatment with UKONIQ.
Consider supportive care as appropriate. Withhold, reduce dose, or
discontinue UKONIQ depending on the severity and persistence of
neutropenia.Diarrhea or Non-Infectious Colitis:
Serious diarrhea or non-infectious colitis occurred in patients
treated with UKONIQ. Any grade diarrhea or colitis occurred in 53%
of 335 patients and Grade 3 occurred in 9%. For patients with
severe diarrhea (Grade 3, i.e., > 6 stools per day over
baseline) or abdominal pain, stool with mucus or blood, change in
bowel habits, or peritoneal signs, withhold UKONIQ until resolved
and provide supportive care with antidiarrheals or enteric acting
steroids as appropriate. Upon resolution, resume UKONIQ at a
reduced dose. For recurrent Grade 3 diarrhea or recurrent colitis
of any grade, discontinue UKONIQ. Discontinue UKONIQ for
life-threatening diarrhea or
colitis.Hepatotoxicity: Serious hepatotoxicity
occurred in patients treated with UKONIQ. Grade 3 and 4
transaminase elevations (ALT and/or AST) occurred in 8% and <1%,
respectively, in 335 patients. Monitor hepatic function at baseline
and during treatment with UKONIQ. For ALT/AST greater than 5 to
less than 20 times ULN, withhold UKONIQ until return to less than 3
times ULN, then resume at a reduced dose. For ALT/AST elevation
greater than 20 times ULN, discontinue UKONIQ. Severe
Cutaneous Reactions: Severe cutaneous reactions, including
a fatal case of exfoliative dermatitis, occurred in patients
treated with UKONIQ. Grade 3 cutaneous reactions occurred in 2% of
335 patients and included exfoliative dermatitis, erythema, and
rash (primarily maculo-papular). Monitor patients for new or
worsening cutaneous reactions. Review all concomitant medications
and discontinue any potentially contributing medications. Withhold
UKONIQ for severe (Grade 3) cutaneous reactions until resolution.
Monitor at least weekly until resolved. Upon resolution, resume
UKONIQ at a reduced dose. Discontinue UKONIQ if severe cutaneous
reaction does not improve, worsens, or recurs. Discontinue UKONIQ
for life-threatening cutaneous reactions or SJS, TEN, or DRESS of
any grade. Provide supportive care as appropriate. Allergic
Reactions Due to Inactive Ingredient FD&C Yellow No.
5: UKONIQ contains FD&C Yellow No. 5 (tartrazine),
which may cause allergic-type reactions (including bronchial
asthma) in certain susceptible persons, frequently in patients who
also have aspirin hypersensitivity.Embryo-fetal
Toxicity: Based on findings in animals and its mechanism
of action, UKONIQ can cause fetal harm when administered to a
pregnant woman. Advise pregnant women of the potential risk to a
fetus. Advise females and males with female partners of
reproductive potential to use effective contraception during
treatment and for at least one month after the last
dose.Serious adverse reactions occurred in 18% of
221 patients who received UKONIQ. Serious adverse reactions that
occurred in ≥2% of patients were diarrhea-colitis (4%), pneumonia
(3%), sepsis (2%), and urinary tract infection (2%). Permanent
discontinuation of UKONIQ due to an adverse reaction occurred in
14% of patients. Dose reductions of UKONIQ due to an adverse
reaction occurred in 11% of patients. Dosage interruptions of
UKONIQ due to an adverse reaction occurred in 43% of patients.
The most common adverse reactions
(>15%), including laboratory abnormalities, in 221 patients who
received UKONIQ were increased creatinine (79%), diarrhea-colitis
(58%, 2%), fatigue (41%), nausea (38%), neutropenia (33%), ALT
increase (33%), AST increase (32%), musculoskeletal pain (27%),
anemia (27%), thrombocytopenia (26%), upper respiratory tract
infection (21%), vomiting (21%), abdominal pain (19%), decreased
appetite (19%), and rash (18%).Lactation: Because
of the potential for serious adverse reactions from umbralisib in
the breastfed child, advise women not to breastfeed during
treatment with UKONIQ and for at least one month after the last
dose.Please visit
www.tgtherapeutics.com/prescribing-information/uspi-ukon for full
Prescribing Information and Medication Guide.
Cautionary StatementThis press
release contains 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 U.S. Private Securities Litigation Reform Act of
1995. Such forward-looking statements include but are not limited
to statements regarding the expectations and plans for the clinical
trials evaluating TG-1701 as monotherapy and in combination with
UKONIQ® (umbralisib) and ublituximab (U2), the availability of
results from those trials, and the potential of TG-1701 as a
treatment for CLL.
In addition to the risk factors identified from
time to time in our reports filed with the U.S. Securities and
Exchange Commission, factors that could cause our actual results to
differ materially include the following: the risk that interim,
top-line, or other early clinical trial results, including the
clinical studies evaluating TG-1701 in combination with U2, will
not be reproduced in final data sets or in future studies; the risk
that the safety profile observed with TG-1701 as monotherapy and in
combination with U2 may change as additional patients are exposed
for longer durations; the risk that TG-1701 as monotherapy or in
combination with U2 will not prove to be safe and efficacious; the
uncertainties inherent in research and development; and the risk
that the ongoing COVID-19 pandemic has an adverse impact on our
research and development plans or commercialization efforts.
Further discussion about these and other risks and uncertainties
can be found in our Annual Report on Form 10-K for the fiscal year
ended December 31, 2020, as updated by our subsequent
Quarterly Reports on Form 10-Q, and in our other filings with
the U.S. Securities and Exchange Commission.
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. CONTACT:
Investor Relations Email:
ir@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 4
Media Relations: Email:
media@tgtxinc.comTelephone: 1.877.575.TGTX (8489), Option 6
TG Therapeutics (NASDAQ:TGTX)
Historical Stock Chart
From Apr 2024 to May 2024
TG Therapeutics (NASDAQ:TGTX)
Historical Stock Chart
From May 2023 to May 2024