Phase III trials of ocrelizumab report positive results in multiple sclerosis- Genentech

Genentech 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 most common form of the disease. The studies (called OPERA I and OPERA II) met their primary and major secondary endpoints. Treatment with ocrelizumab significantly reduced the annualized 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. Based on these results, the company plans to submit the data for review to U.S. and EU regulatory authorities in the first quarter of 2016.

Comment: 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.