Full Press Release Details
Therapeutics, Inc. Announces Double & Triple Combination
Therapy Data Presentations at the 58th American Society of
Hematology Annual Meeting
Combination of TG-1101, TGR-1202 and bendamustine resulted in 71%
ORR, including 43% complete response rate, in relapsed or
TGR-1202 continues to demonstrate a favorable and differentiated
safety profile when combined with a variety of agents
DIEGO, CA (December 6, 2016) - TG Therapeutics, Inc. (NASDAQ:TGTX),
announced the presentation yesterday of data from three combination
studies involving the Company's lead compounds, TGR-1202, the
Company's once-daily PI3K delta inhibitor, and TG-1101
(ublituximab), the Company's novel glycoengineered anti-CD20
monoclonal antibody at the 58th American Society of
Hematology (ASH) Annual Meeting, in San Diego,
S. Weiss, the Company's Executive Chairman and Interim CEO
stated, We are very pleased to continue to see a highly
differentiated safety profile for TGR-1202 across multiple double
and triple combination studies with a high level of activity. Each
of the four clinical studies presented at the ASH meeting, enhanced
our overall understanding of the breadth of activity of TGR-1202.
In addition to DLBCL, FL and CLL, where we have already shown data
previously, it was nice to see the flexibility of TGR-1202 and its
ability to be combined with brentuximab vedotin in relapsed or
refractory Hodgkin's and with ruxolitinib in
Myelofibrosis. Mr. Weiss continued, We are also
encouraged by the triple combination data of TG-1101, TGR-1202, and
bendamustine in relapsed or refractory, difficult to treat, DLBCL
and FL patients which showed no discontinuations for a treatment
related adverse event, as well as an 80% overall response rate
across both DLBCL and FL patients and a high level of CR's.
We, and our investigators, believe this triplet combination is a
promising regimen and plan to study it in this patient population
in a registration-directed trial.
yesterday's presentations include the following:
Presentation: Combination of Ublituximab, TGR-1202, and
Bendamustine Demonstrates Significant Activity in Patients with
Advanced DLBCL and Follicular Lymphoma (Abstract Number
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 and bendamustine. Nineteen patients were
evaluable for safety of which 15 were evaluable for efficacy (3
patients were too early to evaluate and 1 patient had a non-related
adverse event (AE) prior to efficacy assessment). The triple
combination appears well tolerated with no discontinuations for a
treatment related AE. Neutropenia and anemia were the only Grade
3/4 AE's occurring in more than 1 patient. Importantly, no
Grade 3/4 transaminitis was reported, no events of pneumonia or
pneumonitis, and only 1 transient event of Grade 3 diarrhea, with a
duration of 1 day, was observed. Eleven patients (58%) were
refractory to prior treatment. Median time on study at the data cut
off was approximately 6 months with the majority of patients
continuing on study and follow-up ongoing.
from this poster include:
Overall Response Rate (ORR), including a 43% Complete Response (CR)
rate observed in patients with relapsed or refractory
including a 37% CR rate observed in patients with relapsed or
refractory FL 4/6 CR's that
were achieved between the DLBCL and FL groups occurred at the first
8 week efficacy assessment
assessment occurred at Month 3 following initiation of therapy,
with durable responses observed notably amongst DLBCL
Presentation: A Phase I Trial of TGR-1202, a Next Generation
Once-Daily PI3Kd Inhibitor, in Combination with Brentuximab
Vedotin, in Patients with Relapsed/Refractory Hodgkins Lymphoma
poster presentation includes data from patients with relapsed and
refractory Hodgkin's Lymphoma (HL) treated with TGR-1202 at
either 400mg or 600mg dosed orally once daily in combination with
brentuximab vedotin in continuous 21 day cycles. 14 patients were
evaluable for safety, of which 11 were evaluable for efficacy (3
discontinued prior to disease evaluation (2 AE's and 1
withdrew consent)). 43% (6 of 14) of patients had prior exposure to
brentuximab vedotin and all were refractory to prior brentuximab
vedotin therapy. The combination demonstrated tolerability with
nausea, diarrhea, and neutropenia being the most prevalent adverse
events. Notably all but one case of diarrhea was Grade 1 or 2 in
from this poster include:
including a 40% CR rate observed across brentuximab vedotin
including a 45% CR rate observed across all patients
Preliminary Results from a Phase I Dose Escalation Trial of
PI3Kd Inhibitor TGR-1202 in Myelofibrosis (Abstract Number
oral presentation includes data from patients with myelofibrosis
treated with the combination of ruxolitinib, the JAK1/2 inhibitor
and TGR-1202. The combination was well tolerated and efficacious in
the twelve patients treated. The most prevalent adverse events
deemed at least possibly related to TGR-1202 included anemia,
thrombocytopenia, neutropenia, AST/ALT elevation and amylase/lipase
elevation and diarrhea, all of which were notably Grade 1/2 with
the exception of Grade 3 amylase/lipase elevation seen in 2
patients (16.7%), and Grade 3 diarrhea seen in 1 patient (8.3%).
Presentation highlights included:
population enrolled was advanced, with the majority having 2 or
more prior mutations at baseline;
enrolled patients were on a stable dose of ruxolitinib monotherapy
with best response to ruxolitinib monotherapy achieved prior to
addition of TGR-1202, 11/12 patients experienced improvement in
hemoglobin, many with a concomitant reduction in platelet counts
indicating clinical benefit beyond ruxolitinib monotherapy;
participants experienced clinical benefit (hematologic improvement,
reduced spleen size and/or improvement in symptoms) including one