Additional phase III analysis shows consistent impact of RPC 1063 in relapsing multiple sclerosis.- Celgene.

Celgene Corporation announced additional phase III data analyses evaluating the efficacy and safety of RPC 1063 (ozanimod) versus Avonex (interferon beta-1a or IFN beta-1a) in patients with relapsing multiple sclerosis (RMS). The phase III SUNBEAM and RADIANCE Part B studies evaluated two doses of oral ozanimod (1 mg and 0.5 mg ozanimod HCl) compared with IFN beta-1a in patients with RMS. In the new analyses, several pre-specified subgroups, including disability severity at baseline (EDSS at or less than 3.5 vs. EDSS greater than 3.5), presence of gadolinium-enhanced lesions at baseline and prior treatment with disease-modifying therapies, were assessed. Data from these analyses show dose-dependent effects of ozanimod on annualized relapse rates (ARR) versus IFN beta-1a across these subgroups that were consistent with the primary endpoint of both SUNBEAM and RADIANCE Part B. As previously reported for SUNBEAM at one year and for RADIANCE Part B at two years, whole brain volume loss was reduced relative to IFN beta-1a for both the 1 mg dose of ozanimod and the 0.5 mg dose. For both doses, all comparisons were nominally significant.

Additional data in the presentations from exploratory endpoints examined volume loss of specific segments of the brain. Increasing evidence suggests that disease-related damage to grey matter is of major importance in MS. The data analyses to be presented show reductions in cortical grey matter loss and thalamic volume loss are consistent with the reductions in whole brain volume loss seen in SUNBEAM at one year for ozanimod compared with IFN beta-1a. Likewise, reductions in cortical grey matter loss and thalamic volume loss are consistent with the reductions in whole brain volume loss seen in RADIANCE Part B at two years.

In the clinical trials, adverse reactions that occurred in at least 5 percent of patients in either ozanimod treatment group, with at least a 1 percent difference greater than the IFN beta-1a group, were nasopharyngitis, headache, increased alanine aminotransferase, upper respiratory tract infection, hypertension, increased gamma-glutamyltransferase, pharyngitis and urinary tract infections. These additional data analyses from the SUNBEAM and RADIANCE Part B trials are being presented at the 2018 American Academy of Neurology Annual Meeting.