See below the announcement released on 24/09/2025 by our partner, TG Therapeutics. The full press release is attached.
New Data for BRIUMVI® Demonstrate 89.9% of Patients with Relapsing Multiple Sclerosis Were Free from Disability Progression After 6 Years of Continuous BRIUMVI Treatment
September 24, 2025
During year 6 of continuous treatment with BRIUMVI the annualized relapse rate was 0.012, equivalent to one relapse occurring every 83 years of patient treatment
Overall safety profile of BRIUMVI remained consistent over 6 years of continuous treatment, with no new safety signals emerging with prolonged treatment
NEW YORK, Sept. 24, 2025 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced updated data presentations including new six-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS), at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, where we and our Ex-U.S. partner, Neuraxpharm, are exhibiting. Links to each presentation as well as highlights from the presentations are outlined below.
Bruce Cree, MD, PhD, MAS, Zimmermann Endowed Professor in Multiple Sclerosis, and Professor of Neurology at UCSF Weill Institute for Neurosciences, University of California, San Francisco stated, “The data for BRUIMVI at six years of continuous therapy provides compelling evidence of durable efficacy, with sustained protection against not only relapses but also disability progression. These data also underscore the benefit of early treatment with ublituximab compared to delayed treatment on disability outcomes. Furthermore, the consistency of outcomes in clinical trials compared with emerging data from observational studies is striking and strongly supports use of ublituximab in clinical practice.”
Michael S. Weiss, the Company’s Chairman and Chief Executive Officer stated, “We are extremely pleased to share six years of continuous BRIUMVI treatment data demonstrating that nearly 90% of patients on BRIUMVI remained free from disability progression, coupled with one of the lowest relapse rates ever reported in a Phase 3 RMS study. These results, together with the encouraging data from our ongoing ENHANCE dosing trial and the ENABLE real-world observational study, reinforce our confidence in BRIUMVI’s potential to deliver both meaningful efficacy and real-world convenience for people with RMS.”
TG PRESENTATIONS:
Oral Presentation: Long-term Efficacy and Safety of Ublituximab in Relapsing Multiple Sclerosis: Results from Six Years of ULTIMATE I and II Open-label Extension
- Patients on continuous BRIUMVI treatment exhibited low and decreasing annualized relapse rate (ARR) throughout the observation period, ARR: 0.053, 0.032, 0.020, and 0.012 for Years 3, 4, 5, and 6 respectively.
- After 6 years of continuous BRIUMVI treatment, 10.1% of patients had Confirmed Disability Progression (CDP) lasting 24 weeks compared to 15.9% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 0.658; p=0.0238], and 89.9% remained progression free with continuous BRIUMVI treatment.
- 17% of patients treated with BRIUMVI continuously for 6 years achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks compared to 13.3% of patients who switched from teriflunomide to BRIUMVI [HR (95% CI): 1.414; p=0.0396].
- The overall safety profile of BRIUMVI remained consistent over 6 years of continuous treatment in an exposure-adjusted analysis of adverse events (AEs), with no new safety signals emerging with prolonged treatment.
- Immunoglobulin levels remained stable with prolonged BRIUMVI treatment, and the mean IgM and IgG levels remained above the lower limit of normal. There was no association between decreased immunoglobulin levels and risk of serious infections after 6 years of treatment.
ePoster Presentation: Safety and Tolerability of a Modified Ublituximab Dosing Regimen: Updates from the ENHANCE Study
- Consolidating Day 1 (150 mg) and Day 15 (450 mg) BRIUMVI infusions into a single 600 mg dose on Day 1 was well-tolerated across a range of infusion durations, from 1 hour to 4 hours.
- The 4 hour 600 mg BRIUMVI Day 1 infusion was associated with the lowest infusion related reaction (IRR) rate and is currently being evaluated in a double-blinded, randomized, label-enabling trial design compared to standard dosing.
ePoster Presentation: Real-World Clinical Experience from ENABLE: the First Phase 4 Observational Study for Patients with Relapsing Multiple Sclerosis Initiating Ublituximab
- These data demonstrate consistent clinical outcomes with previously conducted pivotal clinical studies. The cohort’s diversity along racial, ethnic, and geographic demographics, provides further understanding of real-world populations on BRIUMVI.
- On-treatment ARR was 0.015 in RMS patients (132.4 patient-years) transitioning to BRIUMVI in real-world clinical setting, with 99.5% of participants reporting no relapses on BRIUMVI.
- Infusion durations in real-world were consistent with the expected infusion times.
- BRIUMVI was well tolerated in real-world clinical setting. IRRs were significantly lower compared to the pivotal ULTIMATE I & II studies.
- Significant improvements in patient-reported outcomes were observed at Day 15 (2nd infusion) and week 24 (3rd infusion).
- The overall safety profile remained consistent in observational study compared to ULTIMATE I and II.
Following the presentations, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.
ABOUT THE ULTIMATE I & II PHASE 3 TRIALS
ULTIMATE I & II are two randomized, double-blind, double-dummy, parallel group, active comparator controlled clinical trials of identical design, in patients with RMS treated for 96 weeks. Patients were randomized to receive either BRIUMVI, given as an IV infusion of 150 mg administered in four hours, 450 mg two weeks after the first infusion administered in one hour, and 450 mg every 24 weeks administered in one hour, with oral placebo administered daily; or teriflunomide, the active comparator, given orally as a 14 mg daily dose with IV placebo administered on the same schedule as BRIUMVI. Both studies enrolled patients who had experienced at least one relapse in the previous year, two relapses in the previous two years, or had the presence of a T1 gadolinium (Gd)-enhancing lesion in the previous year. Patients were also required to have an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline. The ULTIMATE I & II trials enrolled a total of 1,094 patients with RMS across 10 countries. These trials were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University. Additional information on these clinical trials can be found at www.clinicaltrials.gov (NCT03277261; NCT03277248).
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in the EU and UK for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.
The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here Briumvi | European MedicinesAgency (europa.eu).
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) in Europe, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom,
Swissmedic in Switzerland, and Australia’s Therapeutic Goods Administration (TGA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.