A phase 2 multicenter study of ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing forms of multiple sclerosis

Ublituximab, a novel monoclonal antibody (mAb) targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC). Greater ADCC may allow lower doses and shorter infusion times versus other anti-CD20 mAbs. The obje...

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Published in:Multiple sclerosis Vol. 27; no. 3; p. 420
Main Authors: Fox, Edward, Lovett-Racke, Amy E, Gormley, Matthew, Liu, Yue, Petracca, Maria, Cocozza, Sirio, Shubin, Richard, Wray, Sibyl, Weiss, Michael S, Bosco, Jenna A, Power, Sean A, Mok, Koby, Inglese, Matilde
Format: Journal Article
Language:English
Published: England 01.03.2021
Subjects:
gadolinium-enhancing lesions
magnetic resonance imaging
relapse
multiple sclerosis
TG-1101
Ublituximab
ISSN:1477-0970, 1477-0970
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Summary:Ublituximab, a novel monoclonal antibody (mAb) targeting a unique epitope on the CD20 antigen, is glycoengineered for enhanced B-cell targeting through antibody-dependent cellular cytotoxicity (ADCC). Greater ADCC may allow lower doses and shorter infusion times versus other anti-CD20 mAbs. The objective was to determine optimal dose, infusion time, and activity of ublituximab in relapsing multiple sclerosis. This is a phase 2, placebo-controlled study. Patients received three ublituximab infusions (150 mg over 1-4 hours on day 1 and 450-600 mg over 1-3 hours on day 15 and week 24) in six dosing cohorts. The primary endpoint was B-cell depletion. In all cohorts (  = 48), median B-cell depletion was >99% by week 4, maintained at weeks 24 and 48. Most common adverse events (AEs) were infusion-related reactions (all grade 1-2), with no apparent increased incidence at shorter infusion times. There were no AE-related discontinuations. At weeks 24 and 48, no T1 gadolinium-enhancing lesions (  = 0.003) and a 10.6% decrease in T2 lesion volume (  = 0.002) were detected. The annualized relapse rate was 0.07; 93% remained relapse free on study. Overall, 74% of patients had no evidence of disease activity (NEDA). Ublituximab was safely infused as rapid as 1 hour, producing robust B-cell depletion and profound reductions in magnetic resonance imaging (MRI) activity and relapses.
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ISSN:1477-0970
1477-0970
DOI:10.1177/1352458520918375