TG Therapeutics Announces Data Presentations at Upcoming Medical Meetings
TG Therapeutics (NASDAQ: TGTX) announced data presentations scheduled for the ASCO and EHA annual meetings in May and June 2020. The company will present results from three combination trials, highlighting the GENUINE Phase 3 trial's final results that show a PFS benefit for ublituximab in high-risk CLL patients compared to ibrutinib alone. Additionally, long-term results from umbralisib and ibrutinib combinations will be discussed. The presentations emphasize the ongoing development of TGTX's novel therapies targeting B-cell malignancies.
- Final results from the GENUINE Phase 3 trial demonstrate a PFS benefit of ublituximab combined with ibrutinib in high-risk CLL patients.
- Encouraging long-term results from umbralisib and ibrutinib highlight umbralisib's potential versatility.
- TG-1701 shows clinical activity across all evaluated dose levels.
- None.
NEW YORK, May 14, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the schedule of upcoming data presentations at the 56th American Society of Clinical Oncology (ASCO) annual meeting, to be held virtually May 29 – June 1, 2020 and the 25th European Hematology Association (EHA) annual congress, to be held virtually June 11 – 14, 2020. Details of the data presentations are included below.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased to present data from three combination trials at the upcoming June conferences, which we believe underscores the progress we have made in our combinatorial approach, as well as the potential utility of our lead drug candidates in oncology. We are particularly excited to share the final results from the GENUINE Phase 3 trial, evaluating ublituximab in high-risk CLL patients, which is the first randomized trial to demonstrate a PFS benefit with the addition of an anti-CD20 antibody to ibrutinib, compared to ibrutinib monotherapy. Additionally, it is encouraging to see long-term results from the combination of umbralisib and ibrutinib continue to show the potential versatility of umbralisib in combination regimens.“ Mr. Weiss continued, “Lastly, we look forward to presenting updated results from our proprietary triple combination of ublituximab, umbralisib, and our highly selective, BTK inhibitor, TG-1701, which to date has shown encouraging clinical activity at all dose levels evaluated.”
Data to be presented at the ASCO meeting:
Presentation Title: Effect of adding ublituximab to ibrutinib on PFS, ORR, and MRD negativity in previously treated high-risk chronic lymphocytic leukemia: Final results of the GENUINE phase III study
- Abstract Number: 7506
- Available on Demand: Friday, May 29, 2020 at 8:00 AM ET
- Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
- Lead Author: Jeff P. Sharman, MD, Willamette Valley Cancer Institute, US Oncology Research, Eugene, OR
The above abstract is now available via the ASCO meeting website at www.asco.org.
Data to be presented at the EHA meeting:
Presentation Title: Long term results of a Phase I/Ib study of ibrutinib in combination with umbralisib in patients with relapsed/refractory CLL or MCL
- Abstract Number: EP689
- Available on Demand: Friday, June 12, 2020 at 8:30 CEST
- Session Title: Chronic lymphocytic leukemia and related disorders - Clinical
- Lead Author: Matthew Davids, MD, MMSc, Medical Oncology, Dana Farber Cancer Institute, Boston, MA
Presentation Title: Safety and activity of the once daily selective bruton tyrosine kinase (BTK) inhibitor TG-1701 in patients with chronic lymphocytic leukemia (CLL) and lymphoma
- Abstract Number: EP705
- Available on Demand: Friday, June 12, 2020 at 8:30 CEST
- Session Title: Chronic lymphocytic leukemia and related disorders - Clinical
- Lead Author: Chan Cheah, MD, Haematology, Linear Clinical Research, and Sir Charles Gardiner Hospital, Nedlands, Australia
The above abstracts are now available via the EHA meeting website at www.ehaweb.org.
Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing multiple therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) 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 umbralisib (TGR-1202), an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon, which may lead to a differentiated safety profile. Both ublituximab and umbralisib, or the combination of which is referred to as "U2", are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.
Cautionary Statement
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. For these 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 our ongoing and planned clinical trials; the risk that early clinical trial results (both safety and efficacy), that may have supported the acceptance of our data for presentation or influenced our decision to proceed with additional clinical trials, will not be reproduced in the final analyses of the trials or in future studies; 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.
Jenna A. Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com
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