Results from the ORATORIO trial, exploring Ocrevus (ocrelizumab) for the treatment of primary progressive forms of multiple sclerosis (MS), showed that the drug stopped disease progression for more than two years in more patients than a placebo.
The findings, a highlight at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress, Sept. 14-17, in London, raised hope that a treatment for patients with progressive MS may soon be available.
Xavier Montalban, a professor from the Vall d’Hebron University Hospital in Spain presented the study “Evaluation of no evidence of progression using composite disability outcome measures, in patients with primary progressive multiple sclerosis in the ORATORIO trial,” during a Sept. 16 session.
The Phase 3 trial ORATORIO (NCT01194570) randomized 732 primary progressive MS patients to receive either 600 mg of Ocrevus as two 300 mg intravenous infusions 14 days apart (461 patients), or placebo, every 24 weeks (230 patients).
Patients were evaluated every 12 weeks. The treatment was continued for 120 weeks, or until patients experienced a predetermined number of disability progression events.
Researchers measured disability with the Expanded Disability Status Scale (EDSS), but patients were also tested with the 25-foot walk test (T25-FW) and the 9-hole peg test (9-HPT).
The results showed that significantly more patients receiving Ocrevus had no evidence of progression at 120 weeks in comparison to placebo — 42.7 percent and 29.1 percent, respectively. A larger proportion of the treated patients with no disease activity also did better on the additional tests.
“No Evidence of Progression (NEP) is a novel composite endpoint that measures the proportion of patients with no confirmed progression of disability status (EDSS), walking speed (T25-FW) and upper extremity function (9-HPT) and may represent a new outcome for people with PPMS. OCREVUS treatment significantly increased the proportion of PPMS patients with NEP by 47% at 120 weeks compared with placebo in a post-hoc analysis of the ORATORIO study (p=0.0006).” Peter Chin, Principal Medical Director at Genentech Roche, said to Multiple Sclerosis News Today. “Emerging combination endpoints give us a fuller, more comprehensive picture of the MS in clinical trials, and may eventually find their way into clinical practice to help doctors make treatment decisions.”
Ocrevus has also been analyzed in Phase 3 clinical trials for relapsing forms of MS. Those positive results were also recently announced by Roche at ECTRIMS 2016.
The U.S. Food and Drug Administration and the European Medicines Agency have both accepted marketing applications for Ocrevus.