Celgene Corporation has announced that its phase III RADIANCE trial, evaluating the efficacy and safety of ozanimod, an investigational oral, selective S1P 1 and 5 receptor modulator, in patients with relapsing multiple sclerosis (RMS), met the primary endpoint in reducing annualized relapse rate (ARR), compared to weekly interferon (IFN) β-1a (Avonex).
The company said that RADIANCE evaluated two doses (0.5 mg and 1 mg) of oral ozanimod, with patients treated for two years. The trial enrolled 1,313 RMS patients in 21 countries. Both ozanimod 0.5 mg and 1 mg doses demonstrated statistically significant and clinically meaningful reductions in the primary endpoint of ARR and the key secondary endpoints of the number of new or enlarging T2 MRI lesions over 24 months of treatment compared to Avonex and the number of gadolinium-enhancing MRI lesions at 24 months of treatment compared to Avonex.
In a pre-specified pooled analysis of the time to confirmed disability progression in both the RADIANCE and SUNBEAM phase III trials, a very low rate of disability progression was observed across the three treatment groups, and ozanimod did not reach statistical significance compared to Avonex. Additionally, both doses of ozanimod demonstrated statistically significant reductions in brain atrophy compared to Avonex in each phase III trial.
The overall safety and tolerability profile was consistent with results from the recently completed phase III SUNBEAM RMS trial and previously reported phase II trials.
“The results of the phase III RADIANCE trial confirm the data observed in SUNBEAM and are consistent with the long-term phase II RADIANCE trial,” said Bruce Cree, MD, Ph.D., Associate Professor of Neurology, Multiple Sclerosis Center, University of California, San Francisco. “The significant effects seen with ozanimod on relapse and MRI outcomes, including brain volume loss, coupled with the safety and tolerability profile observed in the two phase III trials, represent an exciting advancement for a disease which needs additional oral therapies with favorable benefit-risk profiles.”
Terrie Curran, President of Celgene Inflammation and Immunology said that the company plans to begin submitting global registration dossiers by the end of the year to bring this oral therapy to patients with relapsing multiple sclerosis.
The company noted that further analyses of the RADIANCE trial are ongoing. In February 2017, Celgene announced positive top-line results from the second active comparator phase III, SUNBEAM, in RMS. Detailed results from the RADIANCE and SUNBEAM trials will be presented at an upcoming medical congress. A New Drug Application submission to the U.S. Food and Drug Administration, based on the combined SUNBEAM and RADIANCE trials for RMS, is expected by the end of 2017.