PARIS — Full findings from the phase 3 SUNBEAM and RADIANCE trials expand on previously released topline results showing that the investigational oral agent ozanimod (RPC1063, Celgene) reduces disease progression in patients with relapsing multiple sclerosis (RMS).
Full data from both multicenter, randomized controlled trials were presented for the first time here at the 7th Joint European Committee for Treatment and Research in Multiple Sclerosis-Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2017 meeting.
In SUNBEAM, which included more than 1300 patients, those who received once-daily ozanimod 0.5 mg or 1 mg for 1 year had significantly greater reductions in annualized relapse rate (ARR, the primary endpoint) than patients who received weekly 30-µg intramuscular injections of interferon β-1a (IFN; Avonex, Biogen).
MRI findings showed that the ozanimod group also had greater reductions in gadolinium-enhancing (GdE) lesions and new or enlarging T2 lesions.
“A dose response was consistently demonstrated across efficacy endpoints,” Giancarlo Comi, MD, San Raffaele Scientific Institute at Vita-Salute San Raffaele University in Milan, Italy, told attendees.
In RADIANCE part B, which also included more than 1300 patients with RMS, the groups receiving 0.5 or 1 mg daily of ozanimod had greater ARR reductions at 2 years than the group receiving IFN.
In addition, the number of new or enlarging T2 lesions was reduced by 34% and 42% for the two doses, respectively, compared with IFN, and the number of GdE lesions was reduced by 47% and 53%.
In both trials, there were few serious adverse events (SAEs), which did not differ significantly between treatment groups, and no serious cardiac-related AEs, serious opportunistic infections, or treatment-related deaths occurred.
Jeffrey A. Cohen, MD, Mellen Center for MS Treatment and Research, Cleveland Clinic, Ohio, presented these findings in the meeting’s Late Breaking News session.
“The results of the two trials were largely similar. Both showed benefit on relapse, which was the primary endpoint, and supported secondary endpoints. Importantly, they also showed excellent safety and tolerability,” Dr Cohen told Medscape Medical News.
Celgene notes in a press release that, on the basis of these data, it will be filing a regulatory submission for ozanimod in the United States by the end of this year and in the European Union in the first half of 2018.
SUNBEAM: Primary, Secondary Outcomes
Ozanimod is an immunomodulator that selectively targets sphingosine 1-phosphate 1 (S1P) and 5 receptors. Preliminary topline results from SUNBEAM were reported by the pharmaceutical company in February 2017, and topline results from RADIANCE were reported in May 2017.