On September 23, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from an integrated safety analysis of UKONIQ (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory lymphoid malignancies in Blood Advances, a journal of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, TG Therapeutics, SEP 23, 2021, View Source [SID1234590247]).
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Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, "We are pleased that the integrated safety analysis of 371 patients treated with UKONIQ has been published in Blood Advances. We believe these data further support the differentiated safety profile of UKONIQ, the first and only PI3k-delta and CK1-epsilon inhibitor, which is now commercially available to patients with relapsed or refractory marginal zone lymphoma and follicular lymphoma. As we strive toward obtaining FDA approval of the investigational combination of UKONIQ and ublituximab, U2, in CLL by the PDUFA goal date of March 25, 2022, furthering our understanding of the safety and tolerability profile of UKONIQ remains paramount to us."
Matthew S. Davids, MD, MMSc, lead author of the integrated safety study and Director of Clinical Research in the Division of Lymphoma at Dana-Farber Cancer Institute stated, "Historically, the use of PI3K-delta inhibitors has been limited by high discontinuation rates. The integrated safety data analysis of umbralisib published [today/yesterday] is encouraging for patients, especially given the low rate of discontinuations due to adverse events observed. Our analysis further underscores the potential role of umbralisib in the treatment of relapsed or refractory marginal zone and follicular lymphoma and may support the future utilization of umbralisib in combination therapies for patients with lymphoid malignancies."
The manuscript includes integrated comprehensive toxicity data from 4 open-label phase 1 and 2 studies that included 371 adult patients with relapsed or refractory non-Hodgkin lymphoma (NHL), including patients with follicular lymphoma (n=147), marginal zone lymphoma (n=81), diffuse large B-cell lymphoma/mantle cell lymphoma (n=74), chronic lymphocytic leukemia (n=43) and other (n=25). All patients were treated with umbralisib at 800mg or higher once daily. At data cutoff, median duration of umbralisib treatment was 5.9 months (range, 0.1-75.1), and 107 patients (28.8%) received umbralisib for ≥12 months.
Key highlights from this manuscript include:
The most common grade ≥3 treatment-emergent adverse events (TEAEs) were neutropenia (11.3%), diarrhea (7.3%), and increase aminotransferases (5.7%).
AEs of special interest were limited and included pneumonia in 29 patients (7.8%), noninfectious colitis in 9 patients (2.4%), and pneumonitis in 4 patients (1.1%).
Treatment-emergent serious AEs occurred in 95/371 patients (25.6%).
AEs led to discontinuation of umbralisib in 51 patients (13.7%).
No cumulative toxicity over time was observed.
These data are described further in the manuscript entitled, "Integrated safety analysis of umbralisib, a dual PI3Kδ/CK1ε inhibitor, in relapsed/refractory lymphoid malignancies," which was published online in Blood Advances. The online version of the article can be accessed at View Source