Press Release
« Back
TG Therapeutics, Inc. Announces Data Presentations at the 57th American Society of Hematology Annual Meeting From Ongoing Clinical Studies in Patients With Non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)
Dec 06, 2015
Combination of TG-1101 plus TGR-1202 ("TG-1303") continues to demonstrate a favorable safety profile, with only 8% of patients discontinuing due to an adverse event and no cases of colitis reported to date
80% (8 of 10) ORR in patients with relapsed refractory CLL/SLL treated in the higher dose cohort of TG-1303, including 1 CR and 7 PR's and the remaining 2 patients with stable disease, one still on study with significant reduction in tumor burden (CLL evaluated per iwCLL 2008 criteria)
71% (12 of 17) ORR, including 24% CRs, in patients with heavily pretreated relapsed/refractory Follicular Lymphoma (FL) & Marginal Zone Lymphoma (MZL) treated in the higher dose cohort of TG-1303
35% (6 of 17) ORR in patients with relapsed/refractory DLBCL and Richter's transformation (large cell lymphoma) treated in the higher dose cohort of TG-1303
TGR-1202 based combination therapy with the glycoengineered anti-CD20 mAb, obinutuzumab, plus chlorambucil achieved 100% (15 of 15) ORR in treatment naïve CLL patients, with 33% of patients
achieving a CR, and 47% of patients achieving MRD negativity
Dr.
The following summarizes the posters presented this weekend:
Ublituximab + TGR-1202 Demonstrates Activity and Favorable Safety Profile in Relapsed/Refractory B-Cell NHL and High-Risk CLL: Phase I Results (Abstract Number 1538)
This poster was presented yesterday,
Highlights from this poster include:
- 80% (8 of 10) ORR in patients with
CLL/SLL, including 1 CR and 7 PRs
- Remaining 2 patients had stable disease, one of which remains on study and the other, an ibrutinib refractory patient, progressed after 2 cycles
- 75% of CLL patients had high-risk cytogenetics (17p and/or 11q del)
- Data supports the current Phase 3 UNITY-CLL Study of TG-1101 + TGR-1202 in CLL
- 71% (12 of 17) ORR in heavily pretreated patients with indolent
NHL (FL & MZL), including 4 CRs (24%) and 8 PRs, with 4 of the remaining 5 patients achieving stable disease - 35% (6 of 17) ORR in patients with DLBCL and Richter's Transformation, 3 of which achieved a CR, with 2 additional patients achieving stable disease
- 94% of DLBCL patients were refractory to prior therapy with 69% of patients rituximab refractory, including one patient with triple hit lymphoma
- Of the 16 DLBCL patients, 9 were GCB subtype, 3 were
ABC subtype, and 4 patients' subtype was unknown, with notable activity (ORR and PFS) observed in patients with confirmed GCB subtype
- Combination of 1303 was well tolerated, with only 8% of patients discontinuing due to an adverse event:
- Notably, the only Grade 3/4 adverse event occurring in > 5% of patients was neutropenia. Of the 71 patients available for safety, only 6 patients (8%) discontinued due to a TGR-1202 related event
- Twenty-six patients have been on the combination of TG-1101 plus TGR-1202 for 6+ months, with no events of colitis reported to date
- Safety profile supports multi-drug regimens
A Phase I Trial of TGR-1202, a
The poster was presented today,
Highlights from this poster include:
- 100% (15 of 15) ORR in treatment naïve CLL patients, with 33% of patients achieving a CR, and 47% of patients achieving MRD negativity
- 95% (17 of 18) ORR in treatment naïve and relapsed/refractory CLL patients, with 28% of patients achieving a CR
- Remaining patient achieved a 45% nodal reduction and remains on study, progression-free
- Notably, all previously treated CLL patients were refractory to a prior BTK inhibitor and had at least one high-risk cytogenetic abnormality
- The combination demonstrated acceptable tolerability, which notably differed from that observed when TGR-1202 was combined with TG-1101 in patients with relapsed or refractory CLL, specifically regarding neutropenia (78% vs. 30%), thrombocytopenia (78% vs. < 10%), and transaminase elevations (39% vs. 8%)
- The median PFS has not been reached, with the longest patient on study now 20+ months on TGR-1202 daily maintenance at 800mg
POSTER Presentation details
A copy of the poster presentations are available on the Company's website at www.tgtherapeutics.com, located on the Publications Page, within the Pipeline section.
TG THERAPEUTICS INVESTOR & ANALYST EVENT DETAILS
ABOUT TG THERAPEUTICS, INC.
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, and the anti-PD-L1 and anti-GITR antibodies 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. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101, TGR-1202, the IRAK4 inhibitor program and the anti-PD-L1 and anti-GITR antibodies will not be reproduced in additional patients or in future studies; the risk that trends observed which underlie certain assumptions of future performance of TGR-1202 will not continue, the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current Phase 1 study; the risk that the combination of TG-1101 and TGR-1202, referred to as TG-1303, will not prove to be a safe and efficacious backbone for triple and quad combination therapies; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the 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.
TGTX-G
CONTACT:Source:Jenna Bosco Director- Investor RelationsTG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
News Provided by Acquire Media