DMT04
Efficacy and Safety of Ublituximab Versus Teriflunomide in Relapsing Multiple Sclerosis: Results of the Phase 3 Ultimate I and II Trials

Tuesday, October 26, 2021: 3:30 PM
Gatlin A3/A4 (Rosen Shingle Creek)
Lawrence Steinman, MD , Stanford University School of Medicine, Stanford, CA
Edward J. Fox, MD, PhD , Central Texas Neurology Consultants and Dell Medical School, The University of Texas at Austin, Round Rock, TX
Hans-Peter Hartung, M.D. , Department of Neurology, Medical Faculty, Heinrich Heine University, Dusseldorf, Germany
Enrique Alvarez, MD, PhD , University of Colorado School of Medicine, Aurora, CO
Peiqing Qian, MD , Swedish Neuroscience Institute, Seattle, WA
Sibyl Wray, MD , Hope Neurology, Knoxville, TN
Derrick Robertson, MD , University of South Florida, Morsani College of Medicine, Tampa, FL
DeRun Huang, MD, PhD , MDH Research, Westerville, OH
Krysztof Selmaj, MD, PhD , Medical Academy of Lodz, Lodz, Poland
Daniel Wynn, MD , Consultants in Neurology MS Center, Northbrook, IL
Michael S Weiss, J.D. , TG Therapeutics, New York, NY
Jenna Bosco, BA , TG Therapeutics, New York, NY
Sean Power, BA , TG Therapeutics, New York, NY
Koby Mok, PhD , TG Therapeutics, New York, NY
Bruce A.C. Cree, MD, PhD, MAS , Department of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA



Background: Ublituximab, a novel monoclonal antibody, targets a unique epitope on the CD20 antigen and is glycoengineered for enhanced B-cell cytolysis through anti-body-dependent cellular cytotoxicity (ADCC). The potent ADCC activity is thought to enhance B-cell depletion, and may allow for lower doses and shorter infusion times versus other presently available anti-CD20s mAbs.

Objectives: ULTIMATE I (NCT03277261) and ULTIMATE II (NCT03277248), are identical Phase 3, randomized, multi-center, double-blinded, active-controlled studies evaluating the efficacy and safety of UTX in patients with relapsing multiple sclerosis (RMS).

Methods:

Patients are randomized (1:1) to receive either 450mg UTX via a one-hour intravenous infusion every 24 weeks (following day 1 infusion of 150mg UTX) or 14mg oral teriflunomide once daily, throughout a 96-week treatment period. Eligible patients have diagnosis of RMS (McDonald Criteria 2010), Expanded Disability Status Scale (EDSS) score of 0-5.5, and age of 18-55 years. Subjects are required to have at least 2 documented relapses within the two years prior, one relapse in the year prior, and/or > 1 or more Gd-enhancing lesions in the year prior to screening. The primary endpoint is annualized relapse rate (ARR). Key secondary endpoints include MRI-related outcomes, no evidence of disease activity (NEDA), and 3-month confirmed disability progression. Safety and tolerability are also assessed.

Results: Overall, 1094 patients were randomized in 10 countries (ULTIMATE I, N=549; ULTIMATE II, N=545). Baseline demographic and disease characteristics were previously reported including a mean age of ~37 and ~35 years, a mean MS duration since diagnosis of 4.7 and 5 years, and a mean EDSS of 2.9 and 2.9, respectively in ULTIMATE I&II. Efficacy and safety results from ULTIMATE I&II will be available at the Congress.

Conclusions: ULTIMATE I&II results will evaluate the therapeutic potential of a one-hour 450mg ublituximab infusion every six months, for patients with RMS

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