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Ocrelizumab Reduces Relapses and Disability Progression in Pivotal MS Trials

Monoclonal antibody superior to Rebif

Positive results have been reported from two pivotal studies evaluating the investigational medication ocrelizumab (Genentech/Roche) compared with interferon beta-1a (Rebif, EMD Serono), a standard-of-care therapy, in subjects with relapsing multiple sclerosis (MS), the most common form of the disease. The studies (OPERA I and OPERA II) met their primary and major secondary endpoints.

Treatment with ocrelizumab significantly reduced the annualized relapse rate (ARR) during a 2-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). In addition, 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 magnetic resonance imaging (MRI) scans.

Overall, the incidence of adverse events associated with ocrelizumab was similar to that of 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 that of interferon beta-1a.

OPERA I and OPERA II were phase III, randomized, double-blind, double-dummy, global multicenter studies evaluating the efficacy and safety of ocrelizumab (600 mg administered by intravenous infusion every 6 months) compared with interferon beta-1a (44 mcg administered by subcutaneous injection three times per week) in 1,656 subjects with relapsing forms of MS. The primary endpoint of both studies was the ARR at 2 years (96 weeks). Secondary endpoints included the time to onset of confirmed disability progression; the total number of T1 gadolinium-enhancing lesions; and the total number of new and/or enlarging T2 hyperintense lesions, as detected by brain MRI.

Ocrelizumab is an investigational, humanized monoclonal antibody designed to selectively target CD20-positive B cells. These cells are a specific type of immune cell thought to be key contributors to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS. Ocrelizumab binds to CD20 cell- surface proteins expressed on certain B cells, but not on stem cells or plasma cells. Therefore, the ability to make new B cells is preserved in patients treated with ocrelizumab.

Source: Genentech; June 29, 2015.

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