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TG Therapeutics Announces Publication of Clinical Data from the Phase I/Ib Combination Trial of Ublituximab and Umbralisib (“U2”) in Blood
U2 combination was generally well-tolerated with relatively low rates of immune-mediated toxicities Combination treatment resulted in median progression free
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"U2 combination was generally well-tolerated with relatively low rates of immune-mediated toxicities\n Combination treatment resulted in median progression free survival (PFS) of ~28 months in relapsed/refractory chronic lymphocytic leukemia (CLL) NEW YORK, Sept. 30, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced the publication of results from the multicenter first-in-human Phase I/Ib combination trial of ublituximab, the Company’s anti-CD20 monoclonal antibody, and umbralisib, the Company’s oral once-daily PI3K delta inhibitor in Blood, the Journal of the American Society of Hematology. Dr. Matthew Lunning, of the Fred and Pamela Buffett Cancer Center at the University of Nebraska Medical Center and lead enroller on this trial stated, “I have been involved in the development of umbralisib and ublituximab since 2014, and at our institution we have treated over 60 patients on clinical trials with umbralisib and ublituximab (U2) and/or in combination with other agents. In this dose-escalation study with U2, our goal was to identify the optimal dose for future studies. From a safety standpoint, the combination was generally well-tolerated. Some notable findings included that colitis and hepatic toxicity were nearly absent in this population and overall, we observed relatively low rates of immune-mediated toxicities and opportunistic infections, in contrast to the experience with other PI3K delta class members. We also saw activity across all B-cell lymphomas treated. Taken together, I believe the toxicity, tolerability and efficacy profile make this combination a promising treatment option across B-cell lymphomas and a potential backbone for future triple and quad combinations.” Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “We are extremely pleased to see the U2 Phase I/Ib dose escalation study published in Blood. These data demonstrate the activity of the U2 combination across multiple B-cell cancers and we believe the efficacy demonstrated in our lead indications continue to support our on-going registration programs. Of note, the approximately 28 months of PFS for the CLL cohort at therapeutic doses of umbralisib in this Phase I/Ib study is consistent with our projections for the PFS of U2 in relapsed/refractory patients in our UNITY-CLL study.” Mr. Weiss c...