Core Insights - TG Therapeutics announced significant efficacy results for BRIUMVI (ublituximab-xiiy) in treating highly active relapsing multiple sclerosis (RMS) based on a post hoc pooled analysis of Phase 3 ULTIMATE I and II studies [1][2] Group 1: Efficacy Results - The analysis included 168 participants with highly active disease, showing BRIUMVI reduced the annualized relapse rate (ARR) to 0.145 compared to 0.496 for teriflunomide, a 70.8% relative reduction (P<0.001) [6] - At Week 12, BRIUMVI reduced the least squares mean number of gadolinium-enhancing (Gd+) T1 lesions by 83.3% compared to teriflunomide (0.114 vs 0.683; P<0.001) [6] - Over 96 weeks, Gd+ T1 lesions were reduced by 95.6% with BRIUMVI versus teriflunomide (0.038 vs 0.875; P<0.001) [6] - NEDA-3 rates at Week 12 were 29.5% for BRIUMVI versus 10.1% for teriflunomide, indicating a 4.8-fold higher likelihood of achieving NEDA-3 with BRIUMVI during Weeks 24-96 (77.9% vs 16.4%; P<0.001) [6] Group 2: Study Design and Population - ULTIMATE I and II trials were randomized, double-blind, and included 1,094 patients across 10 countries, with participants receiving either BRIUMVI or teriflunomide for 96 weeks [5][8] - Patients had to have experienced at least one relapse in the previous year or had a T1 gadolinium-enhancing lesion, with an Expanded Disability Status Scale (EDSS) score from 0 to 5.5 at baseline [5] Group 3: Company Overview - TG Therapeutics is focused on developing and commercializing treatments for B-cell diseases, with BRIUMVI approved for various forms of RMS [8][10] - The company emphasizes the importance of early, high-efficacy treatment for patients with aggressive disease, as highlighted by the study results [2][3]

Core Insights - TG Therapeutics announced five-year data from the ongoing open-label extension of the Phase 3 ULTIMATE I and II studies for BRIUMVI, demonstrating durable clinical efficacy and a consistent safety profile over extended treatment [1][2][3] Efficacy Results - The annualized relapse rate (ARR) for patients on BRIUMVI decreased significantly over five years, with rates of 0.053, 0.032, and 0.020 for Years 3, 4, and 5 respectively, indicating one relapse every 50 years of treatment [4] - 97.7% of continuous-treatment participants and 95.0% of switch participants remained relapse-free at Year 5 [4] - After five years, only 8% of patients on continuous BRIUMVI treatment experienced Confirmed Disability Progression (CDP) lasting 24 weeks, compared to 14.3% for those who switched from teriflunomide [4] - 17% of patients on continuous BRIUMVI achieved Confirmed Disability Improvement (CDI) lasting at least 24 weeks, compared to 12.2% for switch participants [4] Safety Profile - The overall safety profile of BRIUMVI remained consistent over five years, with no new safety signals emerging during prolonged treatment [1][4][5] - Immunoglobulin levels were stable, with no association found between decreased levels and serious infections [5] Study Details - The ULTIMATE I & II trials involved over 3,600 participant-years of ublituximab exposure, with more than 85% of eligible participants opting for the long-term open-label extension [3][6] - The trials enrolled a total of 1,094 patients with relapsing forms of multiple sclerosis across 10 countries [6] Company Overview - TG Therapeutics is focused on developing and commercializing novel treatments for B-cell diseases, with BRIUMVI approved for treating adult patients with relapsing forms of multiple sclerosis [7][10]