On June 4, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX), reported updated clinical data from its ongoing Phase 2 study evaluating umbralisib (TGR-1202), the Company’s PI3K delta inhibitor, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy (Press release, TG Therapeutics, JUN 4, 2018, View Source [SID1234527143]). Data from this trial are being presented today during the 54th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.
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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased with the data presented today during the ASCO (Free ASCO Whitepaper) annual meeting. We believe there is a need for novel treatment options for patients who are intolerant to the currently approved BTK and PI3K therapies and believe the data shown today demonstrates that umbralisib can be used effectively in these patients." Mr. Weiss, continued, "We continue to be pleased with the safety and efficacy profile of umbralisib and believe umbralisib single agent, or umbralisib plus ublituximab referred to as ‘U2’, can become important treatment options across multiple b-cell malignancies. We also look forward to presenting updated umbralisib integrated safety data at the European Hematology Association (EHA) (Free EHA Whitepaper) annual congress in a couple of weeks, as well as the topline response rate data from the UNITY-CLL Phase 3 trial by the end of summer 2018."
Highlights from today’s presentation include the following:
Poster Presentation: KI Intolerance Study: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) In Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-delta Inhibitor Therapy (Abstract Number 4314)
This poster presentation includes data from patients with CLL who are intolerant to prior BTK or PI3K delta inhibitor therapy who were then treated with single agent umbralisib (TGR-1202). To be eligible for the study patients had to have received prior treatment with a BTK inhibitor (ibrutinib, acalabrutinib) or a PI3K delta inhibitor (idelalisib, duvelisib) and discontinued therapy due to intolerance within 12 months of starting treatment on this study. Forty-seven patients were evaluable for safety of which 46 were evaluable for Progression Free Survival (PFS), (1 patient had a confirmed Richter’s Transformation (RT) at enrollment which did not meet eligibility criteria).
Highlights from this poster include:
●Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK or PI3K therapy
●Only 13% discontinued due to an adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) also experienced with prior KI therapy
●Nodal reductions were seen in nearly all patients evaluable for response with 3 patients achieving complete resolution of nodal disease, of which 1 patient with 17p del achieved a bone marrow confirmed Complete Response (CR)
●Median progression free survival (PFS) has not been reached with a median follow-up of 9.5 months
●In this relapsed/refractory CLL population, of which 77% required treatment within 6 months of prior KI discontinuation, 68% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, significant clinical activity has been observed
PRESENTATION DETAILS
The above referenced presentation is now available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.