TG Therapeutics Announces Final Long-Term Results from the Phase 3 GENUINE Study Demonstrated that Ublituximab in Combination with Ibrutinib Improved Progression-Free Survival in Patients with High-Risk Relapsed/Refractory Chronic Lymphocytic Leukemia as Compared to Ibrutinib Monotherapy
Combination was well tolerated with no new safety signals identified with median follow-up of >4 years
GENUINE met its primary endpoint of improved overall response rate, as previously reported
TG plans to present these final data at a future medical conference and share these results with the
The Company plans to present these final data at a future medical conference, as well as share the results with the
ABOUT THE PHASE 3 GENUINE STUDY
The Phase 3 GENUINE study is a randomized, open label, multicenter clinical trial to evaluate the safety and efficacy of ublituximab in combination with ibrutinib compared to ibrutinib monotherapy in adult patients with high-risk chronic lymphocytic leukemia (CLL) who received at least one prior therapy for their disease. In this study, high-risk was defined as having any one or more of the following: 17p deletion, 11q deletion or p53 mutation.
The study was conducted at 160 clinical trial sites in the US and
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 two 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 inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. 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 its anti-PD-L1 monoclonal antibody, TG-1501, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1 development. TG Therapeutics is headquartered in New York City.
Some of the statements included in this press release 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. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost effectively complete preclinical and clinical trials; the risk that the combination of ublituximab and ibrutinib studied in the GENUINE Phase 3 trial, will not prove to be a safe and efficacious combination; the risk the company does not share the final GENUINE data with the
Senior Vice President,
Source: TG Therapeutics, Inc.