TG Therapeutics Reports Positive Results for Subcutaneous Briumvi Therapy

By Philip Seaworth • Wednesday, June 03 10:54 • Permanent Link

TG Therapeutics said its phase 1 study of subcutaneous Briumvi generated data that support the quarterly dosing regimen now being tested in phase 3, with more than 100 patients treated in the program and over 225 subcutaneous injections administered.

The company said more than 80 patients received subcutaneous Briumvi across dose levels from 50 mg to 400 mg, and more than 75% of the subcutaneous injections were the 400 mg/2 mL dose. The formulation showed mean bioavailability of greater than 60% versus IV dosing, with the lower bound of the 95% confidence interval above 55%.

TG Therapeutics said modeling based on the phase 1 results points to non-inferior 24-week drug exposure for both phase 3 subcutaneous regimens. For the quarterly regimen, the company cited an estimated geometric mean ratio of 1.21, with the lower bound of the 90% confidence interval at 1.15. For the every-other-month regimen, it cited a geometric mean ratio of 1.58, with the lower bound of the 90% confidence interval at 1.50.

On safety, local injection-site reactions were reported in less than 5% of patients, while systemic injection-related reactions occurred in about 21%. The company said those reactions were not dose dependent, mostly occurred at the first injection, and resolved in 100% of patients. No serious injection-site reactions were observed.

The trial included over 100 patients overall, and the company said B-cell depletion with the subcutaneous version was consistent with IV Briumvi.

In the phase 3 study, the IV arm receives 150 mg on day 1 and 450 mg on day 15, then 450 mg at week 24, for 600 mg total through week 24. The every-other-month subcutaneous arm receives 400 mg on day 1, day 15, week 8 and every 8 weeks thereafter, for 1,600 mg total through week 24. The quarterly subcutaneous arm receives 400 mg on day 1 and 15, week 12 and every 12 weeks thereafter, for 1,200 mg total through week 24.

TG Therapeutics said the phase 3 trial has completed enrollment, with topline data expected in late 2026 or early 2027. It also said a separate device-bridging study for the 400 mg, 2 mL autoinjector format is set to begin later this year. Following these announcements, the company's shares moved 10.25%, and are now trading at a price of $40.395. For more information, read the company's full 8-K submission here.

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