- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Ocrelizumab significantly reduced both relapses and disability progression in two Phase III studies in MS
30 June 2015 • Author: Victoria White
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.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics