On January 30, 2019 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from the multicenter Phase 1 triple combination trial of ublituximab (TG-1101), the Company’s anti-CD20 monoclonal antibody, umbralisib (TGR-1202), the Company’s oral once-daily PI3K delta inhibitor, and ibrutinib, the oral Bruton’s tyrosine kinase (BTK) inhibitor, in The Lancet Haematology (Press release, TG Therapeutics, JAN 30, 2019, View Source [SID1234532958]).
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The paper includes safety and efficacy information from patients with relapsed or refractory B-cell malignancies, including 23 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and 23 patients with non-Hodgkin lymphoma (NHL). Safety data was available from all 46 patients and the triple combination of ublituximab, umbralisib, and ibrutinib was well tolerated with a manageable adverse event profile, and no maximum tolerated dose achieved for the combination. Efficacy data was available from 44 patients and showed the triple combination to be highly active. The overall response rate (ORR) amongst all evaluable patients was 84%, with 100% (22 of 22) of patients with CLL/SLL achieving a response, including 36% achieving a Complete Response (CR). Among patients with NHL, 68% (15 of 22) achieved a response, including a 71% Overall Response Rate (ORR) in follicular lymphoma (FL) (n=7), a 100% ORR in marginal zone lymphoma (MZL) (n=3), and a 100% ORR in mantle cell lymphoma (MCL) (n=6).
These data are described further in the manuscript entitled, "Tolerability and activity of ublituximab, umbralisib, and ibrutinib in patients with chronic lymphocytic leukemia and non-Hodgkin lymphoma: a phase 1 dose escalation and expansion trial," which was featured as the cover article in the February issue of The Lancet Hematology published yesterday. The online version of the article can be accessed at https://www.thelancet.com/journals/lanhae/article/PIIS2352-3026(18)30216-3/fulltext
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated "We want to thank Dr. Loretta Nastoupil and the MD Anderson Cancer Center, as well as each of the participating trial sites and most importantly the patients who participated in this study. Umbralisib has demonstrated unique combinability with other targeted agents, and the data included in this publication further support our goal of developing a proprietary triple combination of ublituximab, umbralisib and our own BTK inhibitor, TG-1701, for which we target commencing clinical trials later this year."