{"id":394517,"date":"2020-12-07T10:18:10","date_gmt":"2020-12-07T15:18:10","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=394517"},"modified":"2020-12-07T10:18:10","modified_gmt":"2020-12-07T15:18:10","slug":"tg-therapeutics-announces-pivotal-data-from-the-unity-cll-and-unity-nhl-clinical-trials-presented-at-the-62nd-american-society-of-hematology-annual-meeting","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tg-therapeutics-announces-pivotal-data-from-the-unity-cll-and-unity-nhl-clinical-trials-presented-at-the-62nd-american-society-of-hematology-annual-meeting\/","title":{"rendered":"TG Therapeutics Announces Pivotal Data from the UNITY-CLL and UNITY-NHL Clinical Trials Presented at the 62nd American Society of Hematology Annual Meeting"},"content":{"rendered":"
\n

\n UNITY-CLL: U2 significantly improved progression-free survival over <\/em>
\n obin<\/em>
\n utuz<\/em>
\n u<\/em>
\n mab<\/em>
\n plus chlorambucil (HR=<\/em>
\n 0<\/em>
\n .54, p<<\/em>
\n 0<\/em>
\n .0001) as well as ORR (p<<\/em>
\n 0<\/em>
\n .001) in patients with CLL; with consistent PFS improvement across treatment na\u00efve CLL (HR=<\/em>
\n 0<\/em>
\n .48) and relapsed\/refractory CLL (HR=<\/em>
\n 0<\/em>
\n .60)<\/em>
\n \n <\/p>\n

\n UNITY-NHL: <\/em>
\n Umbralisib<\/em>
\n monotherapy demonstrated ORR of 49.3% in patients with rel<\/em>
\n apsed<\/em>
\n \/<\/em>
\n refractory <\/em>
\n MZL<\/em>
\n and 45.3% in <\/em>
\n relapsed\/refractory <\/em>
\n FL <\/em>
\n patients <\/em>\n <\/p>\n

\n U<\/em>
\n mbralisib<\/em>
\n monotherapy and the U2 combination exhibited a manageable safety profile with low incidence of immune-mediated toxicities and AE-related discontinuations <\/em>\n <\/p>\n

NEW YORK, Dec. 07, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the presentation of data from the UNITY-CLL Phase 3 trial evaluating the investigational combination of umbralisib and ublituximab (U2) in patients with chronic lymphocytic leukemia (CLL) and the UNITY-NHL Phase 2b trial evaluating single agent umbralisib in patients with relapsed or refractory marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL) and follicular lymphoma (FL), at 62nd<\/sup> American Society of Hematology (ASH) annual meeting and exposition. Presentation highlights are included below.<\/p>\n

Michael S. Weiss, the Company\u2019s Executive Chairman and Chief Executive Officer, stated, \u201cWe are extremely pleased by the pivotal data presented today for our two lead hematology programs, the UNITY-NHL and the UNITY-CLL trials. We believe these data showcase the differentiated profile of umbralisib as a dual PI3K-delta\/CK1-epsilon inhibitor and the potential of the U2 regimen in CLL.\u201d Mr. Weiss continued, \u201cThe UNITY-NHL data presented today supported our current NDA for umbralisib monotherapy, and we continue to work towards our PDUFA goal date of February 15, 2021 for MZL and June 15, 2021 for FL. Additionally, we plan to complete our BLA\/NDA submission for the U2 combination in CLL in the first half of 2021.\u201d<\/p>\n

Speaking to the UNITY-CLL data presented, John Gribben, MD, DSc, Professor of Medical Oncology at St Bartholomew’s Hospital, Barts Cancer Institute, Queen Mary, University of London, and Global Study Chair for the UNITY-CLL Phase 3 trial stated, “Despite recent advances, CLL remains an incurable disease and new treatment options are still very much needed for both relapsed or refractory and treatment na\u00efve patients. The data presented today highlight the first successful Phase 3 trial evaluating a PI3K-delta inhibitor in treatment na\u00efve CLL, a setting where previous PI3K inhibitors have not been able to be safely administered.\u201d Dr. Gribben continued, \u201cThe successful outcome of the UNITY-CLL trial therefore introduces a novel mechanism of action for treatment na\u00efve CLL patients, and if approved, I believe the U2 combination will be a valuable addition to our armamentarium of treatment options for patients with CLL.\u201d<\/p>\n

Speaking to the UNITY-NHL data presented, Pier Luigi Zinzani, MD, PhD, Professor, Institute of Hematology, \u201cL. e A. Ser\u00e0gnoli\u201d, University of Bologna, and Global Chair of the UNITY-NHL study stated, \u201cThe data presented today demonstrate that umbralisib was active and generally well tolerated in patients with heavily pre-treated indolent non-Hodgkin lymphoma.\u00a0Patients with advanced relapsed follicular or marginal zone lymphoma have limited treatment options.\u00a0Umbralisib produced durable responses with a manageable safety profile, and low rates of adverse event related discontinuations.\u00a0Of particular importance is the depth of response achieved in relapsed or refractory MZL, where no patients who achieved a CR have progressed to date at a median follow-up of over two years.\u201d<\/p>\n

\n
\n PRESENTATION<\/u>
\n <\/strong>
\n
\n HIGHLIGHTS: <\/u>
\n <\/strong>\n <\/p>\n

\n
\n Oral Presentation Title<\/u>
\n <\/strong>
\n : <\/strong>
\n
\n Umbralisib<\/strong>
\n <\/a>
\n
\n Plus <\/strong>
\n <\/a>
\n
\n Ublituximab<\/strong>
\n <\/a>
\n
\n (U2) Is Superior to <\/strong>
\n <\/a>
\n
\n Obinutuzumab<\/strong>
\n <\/a>
\n
\n Plus Chlorambucil (<\/strong>
\n <\/a>
\n
\n O+Chl<\/strong>
\n <\/a>
\n
\n ) in Patients with Treatment Na\u00efve (TN) and Relapsed\/Refractory (R\/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study<\/strong>
\n <\/a>\n <\/p>\n