Full Press Release Details
TG Therapeutics, Inc. Announces Preclinical & Clinical Data
Presentations at the 59h American Society of
Hematology Annual Meeting
Clinical presentations continue to underscore safety profile of
TGR-1202 as monotherapy and in combination, including in long-term
Preclinical advances may offer rationale for the differentiated
activity and safety of TGR-1202
GA (December11, 2017) - TG Therapeutics, Inc. (NASDAQ:TGTX),
announces the presentation of six posters highlighting preclinical
and clinical data sets for TGR-1202 (umbralisib), the
Company's once-daily PI3K delta inhibitor, and TG-1101
(ublituximab), the Company's novel glycoengineered anti-CD20
monoclonal antibody, at the 59th American
Society of Hematology (ASH) annual meeting, currently being
held at the Georgia World Congress Center in Atlanta,
S. Weiss, the Company's Executive Chairman and Chief Executive
Officer, stated, "We are very pleased by the data presented
yesterday and today during the ASH annual meeting. The preclinical
data help us to better understand the difference between TGR-1202
and other agents in the class and offers a more complete rationale
for the differentiated safety profile seen in the clinic. With the
updated and expanded integrated safety analysis of TGR-1202 alone
and in combination with other agents, we believe we have provided
the long-term follow-up sufficient to allay any lingering safety
concerns related to TGR-1202 caused by the toxicity profile of
first generation PI3K delta inhibitors. Mr. Weiss continued,
In 2018, with registration-directed data expected in CLL and
NHL, our focus will turn to showcasing the efficacy of TGR-1202 and
our proprietary combination of TG-1101 plus TGR-1202, our U2
combination, ideally leading to NDA/BLA filings in CLL and
following summarizes the highlights from each poster presented at
the ASH 2017 meeting.
Clinical Data Presentations:
An Integrated Safety Analysis of the Next Generation PI3K Delta
Inhibitor Umbralisib (TGR-1202) in Patients with
Relapsed/Refractory Lymphoid Malignancies
presentation includes data that were pooled from 5 completed or
ongoing Phase 1 or 2 studies containing TGR-1202, including a total
of 347 patients with relapsed or refractory hematologic
malignancies. Patients were heavily pretreated, with 50% of
patients having seen 3 or more prior lines of therapy.
from this poster include:
been treated with TGR-1202 across the 5 studies in this pooled
analysis, with median duration of exposure of 6.5 months, and 176
patients on drug for 6+ months, 104 patients for 12+ months, with
the longest patients on daily TGR-1202 for 4+ years
and in an expanded patient population, TGR-1202 exhibits a
differentiated safety profile compared to prior generation PI3K
due to adverse events (AEs) were rare at under 10% for all
commonly associated with PI3K delta inhibitors have been rare, with
pneumonitis (< 0.5%), transaminitis (~2%) and colitis (< 1%),
the latter occurring with no apparent association to time on
tolerability with few discontinuations due to AEs has allowed
patients to remain on continuous dosing to achieve and sustain
promisingly high rates of response:
Response Rate (ORR) for single agent TGR-1202 in
relapsed/refractory Chronic Lymphocytic Leukemia (CLL)
agent TGR-1202 in relapsed/refractory Follicular Lymphoma
KI Intolerance Study: A Phase 2 Study to Assess the Safety and
Efficacy of Umbralisib (TGR-1202) In Patients with Chronic
Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or
PI3K-delta Inhibitor Therapy (Abstract Number 4314)
poster presentation includes data from patients with CLL who are
intolerant to prior BTK or PI3K delta inhibitor therapy who were
then treated with single agent TGR-1202. To be eligible for
the study patients had to have received prior treatment with a BTK
inhibitor (ibrutinib, acalabrutinib) or a PI3K delta inhibitor
(idelalisib, duvelisib) and discontinued therapy due to intolerance
within 12 months of starting treatment on this study. Thirty-three
patients were evaluable for safety (30 patients with ibrutinib
intolerance, and 3 patients with idelalisib intolerance) of which
32 were evaluable for efficacy (1 patient had a confirmed
Richter's Transformation (RT) at enrollment which did not
meet eligibility criteria). TGR-1202 appears to demonstrate a
favorable safety profile in patients intolerant to prior ibrutinib
or idelalisib, with only 2 patients (6%) discontinuing due to an
adverse event, neither of which was a recurrent AE from prior TKI
from this poster include:
patients remain progression-free
study at the data cut off was approximately 6 months with the
majority of patients continuing on study and follow-up
discontinued TGR-1202 due to a recurrent AE which led to
discontinuation from their prior kinase inhibitor
Phase I/II Study of Pembrolizumab in Combination with Ublituximab
(TG-1101) and Umbralisib (TGR-1202) in Patients with
Relapsed/Refractory CLL (Abstract Number 3010)
presentation includes data from patients with relapsed or
refractory Chronic Lymphocytic Leukemia (CLL) or Richter's
Transformation (RT) treated with the triple combination of TG-1101,
TGR-1202, and pembrolizumab. Eleven patients were evaluable for
safety (9 CLL patients and 2 RT patients) and 10 were evaluable for
efficacy (9 CLL and 1 RT), with one patient too early to
from this poster include:
LFTs was observed which met criteria for DLT; patient was
re-challenged and remains on study treatment with TGR-1202
maintenance now 15+ months
patients with relapsed/refractory CLL
BTK refractory CLL patients
durable with the first patient progression-free for 24+
Preclinical Data Presentations: