On March 9, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported the publication of results from the UNITY-NHL Phase 2b trial evaluating UKONIQ (umbralisib), the Company’s inhibitor of PI3k-delta and CK1-epsilon, in patients with relapsed or refractory indolent non-Hodgkin Lymphoma (NHL) in the Journal of Clinical Oncology (JCO) (Press release, TG Therapeutics, MAR 9, 2021, View Source [SID1234576327]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, "We are extremely pleased that the results of the UNITY-NHL trial which supported the recent approval of umbralisib, now called UKONIQ, in relapsed or refractory marginal zone and follicular lymphoma, have been published in the prestigious Journal of Clinical Oncology. The data published yesterday, and previously presented at the ASH (Free ASH Whitepaper) 2020 conference, highlight the utility of UKONIQ across these diseases. As the first and only inhibitor of both PI3K-delta and CK1-epsilon, which is now commercially available, we believe UKONIQ offers an important new treatment option for patients."

Pier Luigi Zinzani, MD, PhD, Professor, Institute of Hematology, "L. e A. Seràgnoli", University of Bologna, and Global Chair of the UNITY-NHL Phase 2b study stated, "The data published yesterday as well as the recent U.S. FDA approval of umbralisib in relapsed or refractory marginal zone lymphoma and follicular lymphoma, are encouraging for patients suffering from these diseases, especially given the lack of a standard of care in these settings. As we see from the UNITY-NHL publication, umbralisib offers meaningful clinical activity across both marginal zone and follicular lymphoma and a manageable safety profile with relatively low rates of immune mediated toxicities and discontinuations due to adverse events."

The manuscript includes data from 208 patients with relapsed or refractory iNHL, including 69 marginal zone lymphoma (MZL), 117 follicular lymphoma (FL), and 22 small lymphocytic lymphoma (SLL) patients who were unresponsive to prior treatments (≥1 MZL; ≥2 FL/SLL), including anti-CD20–based therapy. Patients were administered umbralisib 800 mg orally once-daily until disease progression, unacceptable toxicity, or study withdrawal. The primary end point was overall-response-rate (ORR) as assessed by an independent review committee (IRC) based on the Lugano classification.

Key highlights from this manuscript include:

The ORR was 47.1% across all relapsed or refractory iNHL patients treated (n=208)
At a median follow-up of 27.8 months patients with relapsed or refractory MZL demonstrated:
• 49.3% ORR with 16% Complete response (CR) rate (IRC assessed)
• Median duration of response (DOR) was not reached (95% CI, 10.3 – not estimable) and
• Median Progression Free Survival (PFS) was not reached (95% CI, 12.1 – not estimable)
At a median follow-up of 27.5 months patients with relapsed or refractory FL demonstrated:
• 45.3% ORR with 5.1% achieving a CR (IRC assessed)
• Median DOR of 11.1 months (95% CI, 8.3–15.6)
• Median PFS was 10.6 months
Grade ≥3 treatment emergent adverse events (TEAEs) reported in ≥10% of patients included: neutropenia (11.5%) and diarrhea (10.1%). Increased ALT/AST (grade ≥3) occurred in 6.7%/7.2% of patients.
Other AEs of special interest included pneumonitis (1.4%; grade >3 1.0%) and non-infectious colitis (1.9%; grade >3 0.5%).
A total of 31 patients (14.9%) discontinued due to a treatment-related adverse event.
These data are described further in the manuscript entitled, "Umbralisib, a Dual PI3Kδ/CK1ε Inhibitor in Patients with Relapsed/Refractory Indolent Lymphoma," which was published online yesterday in the Journal of Clinical Oncology. The online version of the article can be accessed at View Source