TG Therapeutics announced it will present comprehensive long-term data for BRIUMVI® (ublituximab-xiiy) at the 2025 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, scheduled for September 24-26, 2025 in Barcelona, Spain. The presentations will showcase six years of follow-up data from pivotal clinical trials and real-world experience in treating patients with relapsing forms of multiple sclerosis (RMS).
Six-Year Efficacy and Safety Results
The centerpiece presentation will feature long-term efficacy and safety results from the ULTIMATE I and II open-label extension studies, representing six years of treatment data. Dr. Bruce Cree from the Weill Institute for Neurosciences at the University of California, San Francisco, will deliver the oral presentation on Wednesday, September 24th at 14:55 CEST.
The ULTIMATE I & II Phase 3 trials were randomized, double-blind, double-dummy, parallel group, active comparator-controlled clinical trials of identical design that treated patients with RMS for 96 weeks. The studies enrolled a total of 1,094 patients with RMS across 10 countries and were led by Lawrence Steinman, MD, Zimmermann Professor of Neurology & Neurological Sciences, and Pediatrics at Stanford University.
Modified Dosing and Real-World Evidence
Two additional ePoster presentations will provide insights into BRIUMVI's clinical application. Barry A. Singer, MD, Director of The MS Center for Innovations in Care at Missouri Baptist Medical Center, will present safety and tolerability data from the ENHANCE study, which evaluated a modified ublituximab dosing regimen.
Dr. Carrie Hersh from the Lou Ruvo Center for Brain Health at Cleveland Clinic will present real-world clinical experience from ENABLE, described as the first Phase 4 observational study for patients with relapsing multiple sclerosis initiating ublituximab treatment.
BRIUMVI's Unique Mechanism
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. The drug is uniquely designed through glycoengineering, a process that removes certain sugar molecules normally expressed on the antibody, allowing for efficient B-cell depletion at low doses.
In the original ULTIMATE trials, patients were randomized to receive either BRIUMVI as an IV infusion of 150 mg administered in four hours, followed by 450 mg two weeks later administered in one hour, and then 450 mg every 24 weeks administered in one hour, or teriflunomide as the active comparator given orally as a 14 mg daily dose.
Safety Profile and Clinical Considerations
The clinical trial data revealed specific safety considerations for BRIUMVI treatment. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively, with three infection-related deaths reported in BRIUMVI-treated patients.
Infusion reactions occurred in 48% of BRIUMVI-treated patients who received premedication prior to each infusion, with the highest incidence within 24 hours of the first infusion. Serious infusion reactions occurred in 0.6% of BRIUMVI-treated patients, with some requiring hospitalization.
The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). The most common adverse reactions in RMS trials with an incidence of at least 10% were infusion reactions and upper respiratory tract infections.
Regulatory Approvals and Market Access
BRIUMVI has received approval from the U.S. Food and Drug Administration for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug has also received approval by the European Commission in Europe, the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, Swissmedic in Switzerland, and Australia's Therapeutic Goods Administration for treating adult patients with RMS who have active disease defined by clinical or imaging features.
The ULTIMATE I & II trials 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-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.
