Ocrelizumab significantly reduced both relapses and disability progression in two Phase III studies in MS

Roche has announced positive results from two pivotal studies evaluating the investigational medicine ocrelizumab compared with interferon beta-1a (Rebif), a standard-of-care therapy, in people with relapsing multiple sclerosis (MS).

The studies (called OPERA I and OPERA II) met their primary and major secondary endpoints.

Treatment with ocrelizumab significantly reduced the annualised relapse rate (ARR) over a two-year period compared with interferon beta-1a, the primary endpoint in both studies. Ocrelizumab also significantly reduced the progression of clinical disability compared with interferon beta-1a, as measured by the Expanded Disability Status Scale (EDSS). Additionally, treatment with ocrelizumab led to a significant reduction in the number of lesions in the brain (areas of disease activity) compared with interferon beta-1a, as measured by MRI.

Overall, the incidence of adverse events associated with ocrelizumab was similar to interferon beta-1a in both studies; the most common adverse events were mild-to-moderate infusion-related reactions. The incidence of serious adverse events associated with ocrelizumab, including serious infections, was also similar to interferon beta-1a.

Roche plan to submit data for ocrelizumab to the US and EU regulatory authorities next year

“Ocrelizumab showed remarkable improvements over a standard-of-care medicine across clinical and imaging endpoints in two pivotal studies,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Ocrelizumab has the potential to make a meaningful difference for people with MS, a chronic and debilitating disease. Based on these compelling results, we plan to submit the data for review to US and EU regulatory authorities in the first quarter of 2016.”

Further analyses of the OPERA studies are ongoing and detailed data will be presented at an upcoming medical congress.

Results from a Phase III study of ocrelizumab in people with primary progressive MS (PPMS), a different form of MS, are expected later this year.