Ocrelizumab Shows Positive Results in Phase III Trials
Positive Phase III trial results were announced yesterday (June 30, 2015) for the experimental medication ocrelizumab, a monoclonal antibody presently being studied for the treatment of different forms of MS. According to a press release issued by Genentech and its parent company Roche, ocrelizumab met both the primary and major secondary endpoints in the Phase III, OPERA I and OPERA II studies.
The total combined enrollment for both studies was 1,656, which included individuals with relapsing forms of MS who either had relapsing-remitting MS or secondary-progressive MS with relapses. Please note that this medication is not being studied in people with secondary-progressive MS who do not experience relapses. Taking place at 307 sites in 40 countries, individuals received either 600 mg of ocrelizumab via intravenous (IV) infusion every six months, or the approved 44-mcg dose of Rebif® (interferon beta-1a), given via subcutaneous injection three-times weekly.
Both the OPERA I and OPERA II studies were randomized, double-blinded, and double-dummy, so neither the patients nor the treating professionals knew which treatment each participant was taking. “Double-dummy” refers to two different treatments for each participant – one with an active drug and one with a placebo. This method is used when the two active treatments being compared cannot be given in an identical manner, which is the case in these trials, where one medication is given via IV every six months, and the other is given via subcutaneous injection three-times weekly.
According to Genentech, when compared to Rebif, ocrelizumab showed “significant reductions” in:
- annualized relapse rate (ARR) over a two-year period
- progression of clinical disability, as measured by the Expanded Disability Status Scale (EDSS)
- number of lesions in the brain (areas of disease activity) as measured by MRI
Please note that specific figures relating to these benefits were not available at the time of publication. The trial results continue to be analyzed and more details on these findings are expected to be announced later in the year, presumably at the upcoming ECTRIMS conference in the fall.
The press release states that mild-to-moderate infusion reactions were the most common adverse events occurring with ocrelizumab, and the incidence of adverse events was similar between both medications. The incidence of more serious adverse events, which included serious infections, was also similar between both medications.
Given the effectiveness and safety data reported, Genentech and Roche plan to submit the data on ocrelizumab to the United States Food and Drug Administration (FDA) as well as the European regulatory authorities in the first quarter of 2016. While headquartered in Switzerland, the Roche Group owns Genentech, which is a pharmaceutical company in the United States.
In addition to the OPERA I and OPERA II studies, Roche is also conducting a study for individuals with primary-progressive MS (PPMS). The Phase III ORATORIO is a safety and efficacy trial of ocrelizumab in 630 patients with PPMS. Results from this study are expected later this year.
For more information about this experimental treatment, please visit the section on ocrelizumab from MSAA’s 2015 edition of the MS Research Update.
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Written by Susan Wells Courtney, MSAA Senior Writer and Creative Director
Reviewed by Jack Burks, MD, MSAA Chief Medical Officer