TG Therapeutics reports seven-year BRIUMVI disability and safety findings
Confirmed disability progression affected 11.7 per cent with continuous treatment versus 17.4 per cent after an initial comparator.
Adrian Kessler
Confirmed disability progression affected 11.7 per cent of continuously treated BRIUMVI patients over seven years, as TG Therapeutics, Inc. NASDAQTGTX reported updated multiple-sclerosis findings on Wednesday. The rate was 17.4 per cent among patients who started on teriflunomide before switching, with p=0.0148.
The follow-up extends two randomized Phase 3 trials into an open-label period in which both groups received BRIUMVI, using a Dec. 31, 2025 cutoff. TG also presented findings on simplifying infusions and developing an injected formulation, potentially expanding the commercial options for its relapsing-MS franchise.
TG is a New York biotechnology company with a growing commercial business focused on immune-mediated diseases.
Shares closed at US$54.53 on Nasdaq on Tuesday, according to NASDAQTGTX at 4:00 p.m. EDT, before Wednesday's announcement. The next scheduled presentation is Friday's initial azer-cel readout in primary progressive MS.
Long-Term Follow-Up Has Limits
The ULTIMATE follow-up poster reports that the original trials randomized 1,094 participants. Subsequently, 422 continuous-treatment patients and 429 switch patients entered the extension. At the cutoff, 271 and 292, respectively, had completed the extension's fifth year.
The reported 88.3 per cent remaining free of confirmed disability progression is a Kaplan-Meier estimate, rather than a simple count of everyone originally randomized. Disability worsening had to persist for at least 24 weeks to qualify.
The comparison tracks earlier versus later initiation of BRIUMVI because the control group switched treatments after the randomized period. It does not provide seven years of comparison against continued teriflunomide treatment.
"BRIUMVI's safety profile remained consistent through seven years of treatment, with no apparent increase in exposure-adjusted adverse event rates over time," TG said in the release.
The poster's safety analysis excluded COVID events. The annualized relapse rate in the continuous-treatment group was 0.018 in year seven.
Simpler Dosing Faces Established Competitors
The Phase 3 ENHANCE poster adds detail to dosing results TG announced on Aug. 3. The randomized, double-blind trial assigned 62 patients to a consolidated start and 61 to the conventional regimen.
The experimental arm received 600 mg initially, while the conventional arm split treatment into 150 mg and 450 mg doses. The trial met its primary endpoint of bioequivalent drug exposure, and neither arm recorded infusion reactions of Grade 3 or higher.
TG describes the single-infusion start as proposed, while the poster identifies the split-dose start as the approved regimen. The materials reviewed supplied no FDA feedback on the study design.
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Roche Holding AG SWXROP OTCMKTSRHHBY already offers intravenous and subcutaneous OCREVUS. Its April 2, 2025 update describes both formulations as six-monthly treatments, illustrating the established alternatives TG faces as it develops another route of administration.
Novartis AG SWXNOVN NYSENVS secured FDA approval for Kesimpta on Aug. 20, 2020, offering a monthly injection patients can administer at home. TG's extension does not establish superiority over either competitor's medicine.
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TG's Aug. 3 financial results reported US$612.3 million in cash, equivalents and investment securities at June 30. United States BRIUMVI sales reached US$227.7 million in the second quarter. Management said the cash balance and projected BRIUMVI revenue would fund its operating plan, without specifying a calendar runway.
That August timetable placed subcutaneous Phase 3 results at year-end 2026 or in the first quarter of 2027. The program is fully enrolled.
The next scheduled presentation is Oct. 23, when TG will report initial Phase 1 azer-cel results in primary progressive MS. The early-stage readout will offer an initial test of its separate cell-therapy approach in progressive disease.
