Efficacy of Ozanimod Versus Interferon β-1a by Prior Treatment and Baseline Disability in Two Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled, Double-Dummy Phase 3 Studies in Relapsing Multiple Sclerosis (SUNBEAM and RADIANCE Part B) (S36.005)

Objective: Evaluate efficacy of ozanimod in pre-planned patient subgroups.

Background: Ozanimod is an oral, once-daily immunomodulator selectively targeting sphingosine 1-phosphate receptors 1 and 5.

Design/Methods Two studies of ozanimod HCl 1 mg or 0.5 mg versus intramuscular interferon (IFN) beta-1a 30 μg for ≥12 months (SUNBEAM, NCT02294058, n=1346) or 24 months (RADIANCE, NCT02047734, n=1313) in relapsing multiple sclerosis (RMS).

Results: In SUNBEAM, adjusted annualized relapse rate (ARR) over the treatment period was lower with ozanimod 1 mg (0.195) and 0.5 mg (0.210) than IFN β-1a (0.338) among disease-modifying treatment (DMT)-naïve patients (69.5% of the population). ARR was also lower for ozanimod 1 mg (0.154) and 0.5 mg (0.299) than IFN β-1a (0.365) among DMT-experienced patients. Based on baseline Expanded Disability Status Scale (EDSS) category (≤3.5 or >3.5), ARR was lower with ozanimod 1 mg (0.170) and 0.5 mg (0.214) than IFN β-1a (0.369) in patients with baseline EDSS ≤3.5 (81.0% of population) and also lower with ozanimod 1 mg (0.145) and 0.5 mg (0.210) than IFN β-1a (0.215) among patients with EDSS >3.5. In RADIANCE, ARR over 24 months was lower with ozanimod 1 mg (0.157) and 0.5 mg (0.228) than IFN β-1a (0.246) among DMT-naïve patients (71.1% of population) and also lower for ozanimod 1 mg (0.205) and 0.5 mg (0.191) than IFN β-1a (0.357) among DMT-experienced patients. ARR was lower with ozanimod 1 mg (0.146) and 0.5 mg (0.183) than IFN β-1a (0.237) among patients with baseline EDSS ≤3.5 (84.6% of population) and lower with ozanimod 1 mg (0.334) and 0.5 mg (0.414) than IFN β-1a (0.531) among patients with EDSS >3.5. Additional subgroup analyses will be presented.

Conclusions: Ozanimod was effective in reducing ARR in DMT-naïve and -experienced patients and across baseline EDSS subgroups of mild and moderate disability, supporting its potential as an effective oral treatment in patients with RMS.

Study Supported by: Celgene

Disclosure: Dr. Kappos has received research support from Bayer HealthCare Pharmaceuticals, Biogen, F. Hoffmann-La Roche Ltd and Genentech,Novartis, Research grants from: the European Union, Roche Research Foundation, Swiss Multiple Sclerosis Society and Swiss National Research Foundation. Dr. Selmaj has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Celgene, Novartis, Merck, Roche. Dr. Bar-Or has nothing to disclose. Dr. Comi has nothing to disclose. Dr. Arnold has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acorda, Biogen, F. Hoffmann-La Roche Ltd, MedDay, MedImmune, Mitsubishi, Novartis, Receptos/Celgene, Sanofi-Aventis. Dr. Arnold has received compensation for serving on the Board of Directors of NeuroRx Research. Dr. Steinman has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Celgene, Merck, Coherus, Atreca. Dr. Steinman has received compensation for serving on the Board of Directors of Atreca, Tolerion. Dr. Steinman has received royalty, license fees, or contractual rights payments from Tolerion. Dr. Steinman has received research support from Coherus, Celgene. Dr. Hartung has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen Idec, GeNeuro, Sanofi Genzyme, Merck, Novartis Pharmaceuticals, Octapharma, Opexa Therapeutics, Teva Pharmaceuticals, MedImmune, Bayer HealthCare, Forward Pharma, and Roche. Dr. Montalban has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Oryzon, Roche, Sanofi and Teva Pharmaceutical.. Dr. Havrdova has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Biogen, Celgene, Merck, Novartis, Sanofi Genzyme and Teva.. Dr. Sheffield has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Celgene. Dr. Raghupathi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Celgene. Dr. Cree has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Abbvie, Biogen, EMD Serono, GeNEuro, Novartis, Sanofi Genzyme. Dr. Cree has received research support from Acorda, Hoffman La Roche, MedImmune, Novartis, Receptos and Teva. Dr. Cohen has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Adams, Celgene.