TG Therapeutics presented updated data from the ENHANCE Phase 3b trial at the 2024 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meeting, showcasing the efficacy and tolerability of rapid 30-minute infusions of BRIUMVI® (ublituximab-xiiy) in patients with relapsing forms of multiple sclerosis (RMS). The study also explored the possibility of eliminating the initial infusion for patients switching from other anti-CD20 therapies. These findings could significantly improve patient convenience and tolerability.
Rapid Infusion Tolerability
The ENHANCE study evaluated optimized dosing regimens for BRIUMVI, focusing on the elimination of the initial 150 mg infusion in B-cell depleted patients and exploring shorter infusion durations for the full 450 mg dose. Notably, 12 patients received 450 mg BRIUMVI infusions in just 30 minutes at week 24. All infusions were completed without interruption or slowing, and infusion-related reactions (IRRs) were limited to Grade 1 (n=2), indicating excellent tolerability.
Streamlined Treatment Transition
The data further support that 450 mg of BRIUMVI can be safely administered in 1 hour as an initial infusion for B-cell depleted participants, with 97% of infusions completed without interruption. This suggests that patients transitioning from prior anti-CD20 therapies may not require the initial 150 mg, 4-hour infusion, simplifying the treatment process.
Management Perspective
Michael S. Weiss, Chairman and CEO of TG Therapeutics, stated, “We are excited to present an update from our ENHANCE Phase 3b study which is evaluating potential optimized dosing regimens for BRIUMVI. We believe the data emerging from this study continues to support that these patients can successfully make that transition conveniently and safely without the initial 150 mg, 4-hour BRIUMVI infusion.” He added, “Separately, we are excited to present, for the first time, data exploring even faster infusions of BRIUMVI, from 1 hour down to 30 minutes for full doses starting at week 24. Notably, these rapid infusions are being accomplished with non-drowsy pre-medications and no required post-infusion observation time as per the protocol, consistent with the BRIUMVI prescribing information. We look forward to continuing to find ways to improve patient tolerability and convenience and working with regulatory agencies to transition these efforts into label-enabling studies.”
About BRIUMVI
BRIUMVI (ublituximab-xiiy) is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. It is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The ULTIMATE I & II phase 3 trials demonstrated its efficacy over teriflunomide in reducing relapse rates and disability progression in RMS patients.
