Long-term follow-up results from the phase 2 multicenter study of ublituximab (UTX), a novel glycoengineered anti-CD20 monoclonal antibody (mAb), in patients with relapsing multiple sclerosis (RMS)
ECTRIMS Online Library. Fox E. Sep 12, 2019; 278225; P1023
Edward Fox
Edward Fox

Abstract: P1023

Type: Poster Sessions

Abstract Category: Therapy - Long-term treatment monitoring

E. Fox1, S. Wray2, R. Shubin3, A. Lovett-Racke4, D. Huang5, A. Bass6, M. Weiss7, S. Power7, J. Bosco7, K. Mok7

1Central Texas Neurology Consultants, Round Rock, TX, 2Hope Neurology, Knoxville, TN, 3Arcadia Neurology Center, Arcardia, CA, 4Department of Microbial Infection and Immunity, The Ohio State University, Columbus, 5Center for Multiple Sclerosis, Mount Carmel Health System, Westerville, OH, 6Neurology Center of San Antonio, San Antonio, TX, 7TG Therapeutics, New York, NY, United States

Objective: To evaluate the long-term safety and tolerability and disability outcomes of ublituximab (UTX) treatment in RMS patients enrolled in the Open Label Extension (OLE) of a phase 2 trial.
Background: UTX is a novel mAb targeting a unique epitope on the CD20 antigen and glyco-engineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC). The greater ADCC potency may offer benefits over currently available anti-CD20s in terms of lower doses and shorter infusion times.
Methods: TG1101-RMS201 was a 52-week, phase 2, placebo-controlled, multicenter study designed to assess the optimal dose and infusion time of UTX in RMS subjects. Subjects who completed the RMS201 study were eligible to continue treatment in the OLE, receiving one-hour 450mg UTX infusions every 24 weeks for an additional 96 weeks. Safety and efficacy are monitored throughout the OLE.
Results: Forty-eight subjects were enrolled in the Phase 2 study. The primary endpoint at Week 48 of the Phase 2 study was to evaluate B-cell depletion. Median B-cell depletion of >99% was observed at Week 4 and maintained at Week 48. At Week 48, key observations included the following: 100% reduction in T1-Gd enhancing lesions; 10.6% mean decrease in T2 lesion volume; 93% of subjects relapse free, and an annualized relapse rate (ARR) of 0.07 was observed. Ublituximab was well tolerated, with the most common adverse event (AE) being infusion related reactions (all grade 1-2). No discontinuations due to AEs were reported. As of the cut-off date, ublituximab continues to be well tolerated, with no discontinuations due to AEs. At the time of presentation, it is anticipated that all patients remaining on the OLE study will have completed week 48 treatment in OLE thus having 96 weeks of total follow-up, and that long-term safety and efficacy will be presented.
Conclusion: The Phase 2 OLE data support that ublituximab continues to be safe, well tolerated and effective with one-hour infusions. These results support the ongoing Phase 3 ULTIMATE program in patients with RMS.
Disclosure: Dr. Edward Fox has received compensation for research, Consulting, Speakers' Bureau, and/or Advisory work from Biogen, Celgene, Chugai, EMD Serono, Genentech/Roche, MedDay, Novartis, Sanofi, Genzyme, Teva, and TG Therapeutics. Dr. Sibyl Wray has conducted research and have been a consultant and speaker for Abbvie, Biogen, EMD Serono, Genentech/Roche, and Genzyme/Sanofi; has conducted research and been a consultant for Novartis; and has conducted research for Celgene and TG Therapeutics. Richard Shubin, MD has no disclosures. DeRen Huang, MD, PhD, served as a consultant for Biogen, Celgene and Novartis; and received speaker honoraria from Biogen, Genentech, Novartis and Teva Neuroscience. Ann Bass, MD has received research funding, advisory board, and/or speaker bureau for Actelion, Biogen, EMD Serono, Genentech-Roche, Mallinckrodt, Novartis, Sanofi-Genzyme and TG Therapeutics. Dr. Amy Lovett-Racke's disclosures include Novartis and TG Therapeutics. Michael S. Weiss, Sean Power, Jenna Bosco, and Koby Mok: Employed by TG Therapeutics

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