Phase III SUNBEAM trial shows ozanimod superior in efficacy and safety to Avonex for treatment of multiple sclerosis.- Celgene.

Celgene Corporation announced detailed results from the phase III SUNBEAM trial evaluating the efficacy and safety of ozanimod, a novel, oral, selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator, versus a first-line treatment, Avonex (interferon beta-1a) (IFN), in patients with relapsing multiple sclerosis (RMS). The results were presented at the MSParis2017 - 7th Joint ECTRIMS - ACTRIMS Meeting, which is being held in Paris, October 25-28, 2017.

The SUNBEAM study evaluated two doses (1 mg and 0.5 mg) of oral ozanimod in 1,346 patients with RMS in 20 countries treated for at least one year. A significant reduction in annualized relapse rate (ARR) was demonstrated for ozanimod 1 mg (ARR=0.18, p < 0.0001) and for ozanimod 0.5 mg (ARR=0.24, p=0.0013) compared with IFN (ARR=0.35) over an average of 13.6 months of treatment. Ozanimod demonstrated a significant reduction in new or enlarging T2 lesions over one year for 1 mg (48 percent, p < 0.0001) and 0.5 mg (25 percent, p=0.0032) compared with IFN. A significant reduction in gadolinium-enhanced MRI lesions at 1 year was also demonstrated for ozanimod 1 mg (63 percent, p < 0.0001) and ozanimod 0.5 mg (34 percent, p=0.0182) compared with IFN. In SUNBEAM, a reduction in brain volume loss, a measure associated with MS disease progression, was observed for the ozanimod dose groups compared with the IFN group. Whole brain volume loss was reduced by 33 percent with the 1 mg dose of ozanimod (median percent change from baseline to 1 year:-0.39, nominally significant p < 0.0001) and by 12 percent in the 0.5 mg group (-0.50, p=0.06) versus IFN (-0.57) at one year. In a pre-specified pooled analysis of the SUNBEAM and RADIANCE Part B studies, ozanimod did not reach statistical significance compared with IFN in the time to 3-month confirmed disability progression. A very low rate of disability progression was observed across all treatment groups. In SUNBEAM, the number of patients with 3-month confirmed disability progression by the end of the study was 13 (2.9 percent) in the ozanimod 1 mg group and 17 (3.8 percent) in the ozanimod 0.5 mg group compared with 19 (4.2 percent) in the IFN group. Treatment-emergent adverse events (AEs) were experienced by 59.8 percent of patients on ozanimod 1 mg, 57.2 percent on ozanimod 0.5 mg and 75.5 percent on IFN. The percentages of patients who discontinued study drug due to AEs were 2.9 percent for ozanimod 1 mg, 1.5 percent for 0.5 mg and 3.6 percent for IFN. The overall safety and tolerability profile was consistent with results from the previously reported phase II RADIANCE Part A study in RMS.