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TG Therapeutics Announces Data Presentations at the XVIII International Workshop on Chronic Lymphocytic Leukemia (iwCLL)
Phase 2 study of umbralisib monotherapy in BTK/PI3K-delta intolerant CLL reports an estimated median progression-free survival (PFS) of 23.5 months (n=50)
About this update from Tg Therapeutics, Inc.
[{"type":"text","content":"Phase 2 study of umbralisib monotherapy in BTK/PI3K-delta intolerant CLL reports an estimated median progression-free survival (PFS) of 23.5 months (n=50) with 58% of patients on umbralisib longer than their prior kinase inhibitor therapy\n Phase 1/2 study of U2 + Pembrolizumab reports 83% (5 of 6) ORR in BTK refractory CLL patients, with 4 of 5 responders achieving a response to U2 alone prior to introduction of pembrolizumab NEW YORK, Sept. 23, 2019 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that data from two Phase 1/2 trials were presented at the XVIII International Workshop on Chronic Lymphocytic Leukemia (iwCLL), currently being held in Edinburgh, Scotland. These data were previously presented earlier this year at the 15th International Conference on Malignant Lymphoma (ICML), held in Lugano, Switzerland. Highlights from the presentations are included below. Presentation Title: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy This 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. To be eligible for the study patients had to have received prior treatment with a BTK inhibitor or a PI3K delta inhibitor and discontinued therapy due to intolerance and were in need of subsequent therapy. Fifty-one patients were evaluable for safety of which 50 were evaluable for Progression Free Survival (PFS). Data highlights include: Umbralisib demonstrated a favorable safety profile in patients intolerant to prior BTK (ibrutinib or acalabrutinib) or PI3K delta (idelalisib) therapyOnly 12% discontinued due to an umbralisib adverse event, of which only one patient discontinued due to a recurrent adverse event (AE) previously experienced with prior kinase inhibitor therapy (ibrutinib)In this previously treated CLL population, 67% had a high-risk molecular / genetic marker and 6% had an ibrutinib resistance mutation, the estimated median progression free survival (PFS) was 23.5 months and overall survival (OS) not reached at a median follow-up of 15.7 monthsAs of the cut-off date, 58% of patients have been on umbralisib for a duration longer than their prior BTK or PI3k inh...