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TG Therapeutics, Inc. Announces Presentation of Single Agent Data for Both TG-1101 and TGR-1202 in Ongoing Phase I Clinical Studies
May 30, 2014
Highlights from TG-1101 Data Include:
- 100% of CLL patients achieved a peripheral response with 67% achieving a partial response
- 44% of Indolent NHL patients achieved a complete response (22%) or partial response (22%)
- Well tolerated at highest doses tested, with infusion time averaging 90 minutes in later infusions
Highlights from TGR-1202 Data Include:
- 100% of evaluable CLL patients treated at ≥ 800 mg exhibited significant nodal reductions, with approximately 80% achieving a partial response or a nodal partial response with lymphocytosis
- Additional responses seen in Hodgkin's Lymphoma and Indolent NHL
- No drug related hepatic toxicity or colitis observed to date, with patients on study for over 1 year
Today's poster presentations include data from 35 patients with rituximab relapsed and refractory hematologic malignancies treated with TG-1101 at doses ranging from 450 mg to 1200 mg, and from 40 patients with relapsed and refractory hematologic malignancies treated with TGR-1202 at doses ranging from 50 mg to 1800 mg QD.
Overview of the data presented on TG-1101:
Safety and Tolerability
TG-1101 (ublituximab) was well tolerated at all dose levels tested in 35 patients evaluable for safety, with Day 1 infusion related reactions (IRR) being the most frequently reported adverse event. All IRR's were Grade 1 or 2 in severity, were manageable and occurred more frequently in patients with CLL. Infusion times for the fourth and later infusions of TG-1101 averaged approximately 90 minutes.
Clinical Activity
The overall response rate (ORR) for the Phase 1 dose escalation component and expansion cohort was 43% (30% PR, 13% CR) among the 30 rituximab relapsed/refractory patients evaluable for efficacy. TG-1101 displayed marked clinical activity as a single agent in a variety of lymphoma subtypes, reporting a 67% (4/6) response rate in patients with CLL and 44% (8/18) response rate in iNHL (22% CR, 22% PR). A breakdown of response by lymphoma subtype is below:
Lymphoma Type |
Pts (n) |
CR n (%) |
PR n (%) |
ORR n (%) |
CLL | 6 | -- | 4 (67) | 4 (67) |
iNHL | 18 | 4 (22) | 4 (22) | 8 (44) |
aNHL | 6 | -- | 1 (17) | 1 (17) |
Total | 30 | 4 (13) | 9 (30) | 13 (43) |
Among patients with CLL, depletion of circulating lymphocytes was rapid and profound with 100% of patients achieving a peripheral response (defined as either a normalization in absolute lymphocyte count (ALC) or > 50% reduction in ALC from baseline) with a median time to peripheral response of 1 Day and a median reduction in ALC at the first response assessment in excess of 90%.
A graph accompanying this release is available at http://media.globenewswire.com/cache/8790/file/26740.pdf
Responses have been durable, with a median progression free survival (PFS) among patients who achieved SD or better not yet reached, and a median PFS for all patients on study of 34 weeks (n=30). A number of patients in SD or better have continued on TG-1101 maintenance therapy, with improved responses observed over time with continued treatment.
Commenting on the Phase I data, Dr. Owen A. O'Connor, Director of Lymphoid Malignancies, Professor of Medicine and Experimental Therapeutics at
Overview of the data presented on TGR-1202:
Safety and Tolerability
TGR-1202 has been well-tolerated with no dose-related trends in adverse events observed and no MTD reached to date. Grade 3 events continue to be limited. Notably, of the 40 patients evaluable for safety, no drug related transaminase elevations or events of colitis have been observed, with several patients on daily TGR-1202 for over 1 year.
Clinical Activity
Clinical activity was observed in patients with CLL treated at doses ≥ 800 mg with all (9/9) patients exhibiting significant nodal reductions. Seven of nine evaluable patients (78%) exhibited a nodal response ( > 50% reduction in nodal size) of which three of these patients achieved a partial response per the IWCLL 2008 criteria. The remaining two patients exhibited > 40% reductions in nodal size at first efficacy assessment and remain on study awaiting upcoming efficacy assessments.
Among all disease types, 26 patients had been treated at doses ≥ 800 mg and were evaluable for efficacy (including patients who started at lower doses and were escalated), with 20/26 (77%) achieving a reduction in nodal size with TGR-1202. In addition to CLL, responses were observed in patients with follicular lymphoma (1 PR of 2 evaluable patients started at ≥ 800 mg) and Hodgkin's lymphoma (1 PR of 4 evaluable patients started at ≥ 800 mg).
Enrollment into the study continues as dose escalation of a recently introduced micronized formulation of TGR-1202 dosed in a fed state is ongoing. We project these modifications will provide exposures 3-4 fold greater than those seen with equivalent doses of the previous formulation of TGR-1202 dosed in a fasting state.
Dr.
Presentation details are as follows:
Title: A phase I trial of ublituximab (TG-1101), a novel glycoengineered anti-CD20 monoclonal antibody in B-cell non-Hodgkin lymphoma patients with prior exposure to rituximab.
- Abstract Number: 8524
- Presentation Date & Time: Friday, May 30, 2014, 1:00 PM - 4:00 PM CT
- Poster Display: Room S405, Poster Board #4
-
Presenter: Owen A. O'Connor, MD, PhD, Columbia University Medical Center, New
York, NY -
Discussion Session: 4:30 -
5:45 PM CT ; Room S406 - Link to Poster: www.tgtherapeutics.com/ASCO2014-Poster-8524.pdf
Title: Activity of TGR-1202, a novel once-daily PI3K delta inhibitor, in patients with relapsed or refractory hematologic malignancies.
- Abstract Number: 2513
- Presentation Date & Time: Friday, May 30, 2014, 1:00 PM - 4:00 PM CT
- Poster Display: Room E354b, Poster Board #27
- Presenter: Howard A. Burris, MD, Sarah Cannon Research Institute, Nashville, TN
-
Discussion Session: 4:30 -
5:45 PM CT ;E Arie Crown Theater - Link to Poster: www.tgtherapeutics.com/ASCO2014-Poster-2513.pdf
ABOUT
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials, the timing of commencing, completing or reporting such trials, the business prospects for TG-1101 and TGR-1202, the potential benefits of combining TG-1101 and TGR-1202 and the potential benefits that might be achieved with the micronized formulation and fed-state dosing 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 and TGR-1202; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that the enhanced absorption seen in the healthy human volunteer bioequivalence studies will not be seen in whole or in part when the modified formulation and fed-state dosing are studied in patients with B-cell malignancies; 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 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
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