Exhibit 99.1
TG Therapeutics Highlights Data Selected for Presentation at the 62nd American Society of Hematology (ASH) Annual Meeting
UNITY-CLL: U2 significantly improved progression-free survival over obinutuzimab plus chlorambucil (HR=0.54, p<0.0001) as well as ORR (p<0.001) in patients with CLL; with consistent PFS improvement across treatment naïve CLL (HR=0.48) and relapsed/refractory CLL (HR=0.60)
UNITY-NHL: Umbralisib monotherapy demonstrated ORR of 49.3% in patients with relapsed/refractory MZL and 45.3% in relapsed/refractory FL patients
U2 plus venetoclax demonstrated 100% ORR, 80% uMRD in the peripheral blood and 68% uMRD in the bone marrow in patients with relapsed/refractory CLL at cycle 12 of therapy (n=19)
TG-1701(BTK inhibitor) monotherapy in the 200mg expansion cohort (n=21) demonstrated an 85% ORR in patients with relapsed/refractory CLL
Umbralisib monotherapy and the U2 combination across all abstract trials exhibited a manageable safety profile with low incidence of immune-mediated toxicities and AE-related discontinuations
Conference call with leading investigators from the UNITY-NHL and UNITY-CLL trials to be held tomorrow, November 5, 2020 at 8:45 AM ET
NEW YORK, NY (November 4, 2020) - TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the release of four abstracts that will be presented at the upcoming 62nd American Society of Hematology (ASH) annual meeting and exposition, to be held virtually December 5 – 8, 2020. Abstracts are now publicly available online via the ASH meeting website at www.hematology.org. The Company is also hosting a zoom conference call tomorrow, November 5, 2020, at 8:45 AM ET, with leading investigators from the UNITY-NHL and UNITY-CLL trials. Abstract highlights, as well as details about the ASH presentations and the conference call are outlined below.
Michael S. Weiss, Executive Chairman and Chief Executive Officer, stated, “We are excited to share the first data from the pivotal UNITY-CLL Phase 3 trial evaluating the combination of ublituximab and umbralisib (U2) in treatment naïve and relapsed/refractory CLL, which is the first randomized trial with a PI3K inhibitor in treatment naïve CLL. In addition, we are equally excited to present updated data from the UNITY-NHL trial which supported our NDA for umbralisib, and updated data from two triple therapy datasets, including U2 plus TG-1701, our BTK inhibitor, and U2 plus venetoclax in CLL. Importantly, we believe these data showcase the differentiated tolerability profile of umbralisib, our once daily, dual PI3K-delta and CK1-epsilon inhibitor and the potential of umbralisib monotherapy and the U2 combination in FL, MZL, and CLL. We look forward to discussing these data sets during tomorrow’s call with some of our leading investigators from the UNITY-CLL and UNITY-NHL trials.”