TG Therapeutics Announces Positive Outcome from UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Feb 28, 2019
Study met the primary endpoint of Overall Response Rate (ORR)
Interim data to be presented in an oral presentation at the 2019
Umbralisib was previously granted Breakthrough Therapy Designation based on interim data from the marginal zone lymphoma (MZL) cohort of the UNITY-
Conference call to be held today,
Interim safety and efficacy data from this study will be presented in an oral presentation at the upcoming
Mr. Weiss continued, “There are no fully approved drugs for MZL, and thus remains an unmet medical need and we are excited by the potential to offer a novel treatment for this underserved population. We look forward to discussing the results with the
About the UNITY-NHL Phase 2b Study—Marginal Zone Lymphoma Cohort
The multicenter, open-label, UNITY-NHL Phase 2b study - Marginal Zone Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, the Company’s novel, once daily, PI3K delta inhibitor, in patients with MZL who have received at least one prior anti-CD20 regimen. The primary endpoint is overall response rate (ORR) as determined by Independent Review Committee (IRC) assessment. The primary analysis of ORR will be conducted once all treated patients have had at least 9 cycles (Cycle = 28 days) of follow-up. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).
The MZL cohort completed enrollment in
2019 AACR Oral Presentation Details
Abstract titles are now available online and can be accessed on the AACR meeting website at www.aacr.org. The complete text of the abstract will be available on the meeting website on
- Title: Umbralisib monotherapy demonstrates efficacy and safety in patients with relapsed/refractory marginal zone lymphoma: A multicenter, open-label, registration directed Phase II study
• Session Date and Time:
Monday April 1, 2019 3:00 PM - 5:00 PM ET
• Session Title: The Next Generation of Clinical Trials in Molecularly-driven Therapy
• Session Location:
Marcus Auditorium- Bldg A-GWCC
Nathan Fowler, MD, Associate Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX
• Abstract Number: 7821
Following the 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.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, Thursday, February 28, 2019 at 8:30 AM ET to discuss the UNITY-NHL MZL results.
In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call.
A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
ABOUT MARGINAL ZONE LYMPHOMA
Marginal zone lymphoma (MZL) comprises a group of indolent (slow growing) B-cell non-Hodgkin lymphomas (NHLs) that begin forming in the marginal zone of lymphoid tissue. With an annual incidence of approximately 7,500 newly diagnosed patients, MZL is the third most common B-cell
ABOUT BREAKTHROUGH THERAPY DESIGNATION
The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over available therapies.
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 interim clinical trial results from the UNITY-NHL MZL cohort that supported Breakthrough Therapy Designation (BTD) or that were accepted for presentation at AACR will not be reproduced in the final data, or if positive, will not be sufficient to support a filing for approval; the risk that the positive data from the UNITY-NHL MZL cohort will not be reproduced in future studies or in other cohorts of the UNITY-
Senior Vice President,
i Denlinger NM, Epperla N, William BM. Management of relapsed/refractory marginal zone lymphoma: focus on ibrutinib. Cancer Manag Res. 2018 Mar 27;10:615-624. doi: 10.2147/CMAR.S133291. eCollection 2018
Source: TG Therapeutics, Inc.