TG Therapeutics Inc. (NASDAQ:TGTX) has announced two triple combination data presentation. The company’s first presentation evaluated the experimental combination of umbralisib and ublituximab plus venetoclax in R/R chronic lymphocytic leukemia patients. On the other hand, the second presentation included an evaluation of the investigational combination of U2 and TG-1701 in R/R CLL or B-cell lymphoma. TG-1701 is the company’s oral, once-daily BTK inhibitor.
UNITY-NHL study data to support NDA for umbralisib monotherapy
Michael Weis, TG Therapeutics’ CEO and Executive Chairman, stated that they are delighted with the triple therapy data they presented at the 62nd American Society of Haematology annual conference. Weis said that the data demonstrates U2’s potential both with TG’s BBTK inhibitor, TG-1701, and venetoclax. He added that the company’s mission is driving towards better outcomes for B-cell malignancies patients through multi-drug therapy combinations.
The first presentation was data from the phase 3 UNITY-CLL trial that evaluated U2 in CLL patients and also the UNITY-NHL Phase 2b trial that evaluated single-agent umbralisib in R/R marginal zone lymphoma, follicular lymphoma, and small lymphocytic lymphoma. Weis said that through the UNITY-NHL and UNITY-CLL studies’ data, they demonstrated umbralisib can be a dual PI3K-delta/CK1-epsilon inhibitor and a possible U2 regimen in CLL. He added that the UNITY-NHL data will support the company’s NDA for umbralisib monotherapy. TG Therapeutics is working towards its PDUFA goal date of February 15, 2021, for marginal zone lymphoma and June 15, 2021, for follicular lymphoma.
TG Therapeutics presents ULTIMATE I & II studies data
The company also presented the Phase 3 ULTIMATE I & II studies’ data to evaluate the company’s experimental glycoengineered anti-CD20 monoclonal antibody, ublituximab compared to teriflunomide in relapsing multiple sclerosis patients. The studies met the primary endpoint with ublituximab showing a statistically significant reduction in annualized relapse rate. The studies evaluated the efficacy and safety of one-hour 450 mg of ublituximab infusion every six months after the first infusion. The company conducted the studies under the Special Protocol Assessment agreement with the FDA. Data from the studies will support a Biologics License Application (BLA) for ublituximab in RMS by mid-2021.