Business
TG Therapeutics Reports Positive Interim Data from UNITY-NHL Phase 2b Trial Evaluating Umbralisib Monotherapy in Patients with Marginal Zone Lymphoma at the 2019 AACR Annual Meeting
Overall response rate (ORR) of 52% (N=42), with complete response (CR) rate of 19%, by central independent review committee (IRC) Responses were durable, with
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"Overall response rate (ORR) of 52% (N=42), with complete response (CR) rate of 19%, by central independent review committee (IRC) Responses were durable, with median duration of response (DOR) not reached at median 12.5 months follow-up, and all patients in complete response remain on study Umbralisib was well tolerated with a safety profile that appeared to be maintained with prolonged exposure Umbralisib previously granted Breakthrough Therapy Designation for the treatment of patients with relapsed/refractory MZLCompany to host conference call today, April 1, 2019 at 12:00pm (noon) ET, with Dr. Nathan Fowler of MD Anderson Cancer Center and Study Chair of the MZL cohort, to discuss the interim resultsNEW YORK, April 01, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) today reported positive interim data from the ongoing single-arm marginal zone lymphoma (MZL) cohort of its Phase 2b clinical trial known as UNITY-NHL. The MZL cohort of UNITY-NHL is designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. Umbralisib is an investigational, oral, once daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).The interim data were reported this morning by Dr. Nathan Fowler, Associate Professor of Medicine and Director of Clinical Research in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center and Study Chair of the UNITY-NHL MZL cohort, during this morning's official 2019 Press Program at the American Association of Cancer Research (AACR) Annual Meeting. Dr. Fowler will also present the data during an oral session this afternoon (details below).Summary of Data Presented:The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported today included safety and tolerability data on all 69 treated patients (safety population) and efficacy data on 42 patients who were enrolled at least 9 cycles (28 day cycles) prior to the data cut-off date (interim efficacy population). The primary endpoint is overall re...