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TG Therapeutics, Inc. Announces Double & Triple Combination Therapy Data Presentations at the 58th American Society of Hematology Annual Meeting
Dec 06, 2016
Combination of TG-1101, TGR-1202 and bendamustine resulted in 71% ORR, including 43% complete response rate, in relapsed or refractory DLBCL
TGR-1202 continues to demonstrate a favorable and differentiated safety profile when combined with a variety of agents
Highlights from yesterday's presentations include the following:
Poster Presentation: Combination of Ublituximab, TGR-1202, and Bendamustine Demonstrates Significant Activity in Patients with Advanced DLBCL and Follicular Lymphoma (Abstract Number 4197)
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 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.
Efficacy highlights from this poster include:
- 71% (5 of 7) Overall Response Rate (ORR), including a 43% Complete Response (CR) rate observed in patients with relapsed or refractory DLBCL
- 88% (7 of 8) ORR, 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
- First response assessment occurred at Month 3 following initiation of therapy, with durable responses observed notably amongst DLBCL patients.
Poster Presentation: A Phase I Trial of TGR-1202, a
This 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 severity.
Efficacy highlights from this poster include:
- 60% (3 of 5) ORR, including a 40% CR rate observed across brentuximab vedotin refractory patients
- 64% (7 of 11)
ORR, including a 45% CR rate observed across all patients treated
Oral Presentation: Preliminary Results from a Phase I Dose Escalation Trial of Ruxolitinib and the PI3Kδ Inhibitor TGR-1202 in Myelofibrosis (Abstract Number 1125)
This 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:
- The patient population enrolled was advanced, with the majority having 2 or more prior mutations at baseline;
- Per protocol, all enrolled patients were on a stable dose of ruxolitinib monotherapy with best response to ruxolitinib monotherapy achieved prior to enrollment;
- Following the 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; and
- 83% of study participants experienced clinical benefit (hematologic improvement, reduced spleen size and/or improvement in symptoms) including one patient who achieved a CR and continues on study, now out 72 weeks
PRESENTATION DETAILS:
Copies of the above referenced presentations are available on the Company's website at www.tgtherapeutics.com, located on the Publications page.
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Cautionary Statement
Some of the statements included in this press release, particularly those with respect to anticipating future clinical trials, the timing of commencing or completing such trials and business prospects for TG-1101, TGR-1202, the IRAK4 inhibitor program, the
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CONTACT:Source:Jenna Bosco Vice President, Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
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