- Phase III study meets primary endpoint in debilitating form of multiple sclerosis with no approved treatments
- Ocrelizumab is the first investigational medicine to show positive study results in both primary progressive and relapsing forms of multiple sclerosis
- Genentech will submit data to the U.S. Food and Drug Administration for both forms of multiple sclerosis in early 2016
South San Francisco, CA — September 27, 2015 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from a pivotal Phase III study that evaluated the investigational medicine ocrelizumab in people with primary progressive multiple sclerosis (PPMS). The study (called ORATORIO) met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo, as measured by the Expanded Disability Status Scale (EDSS).
Overall, the incidence of adverse events associated with ocrelizumab was similar to placebo; 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 placebo.
“People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease, and there are no approved treatments for this debilitating condition,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in primary progressive MS.”
The positive study results observed with ocrelizumab in both people with PPMS (ORATORIO) as well as those with relapsing forms of MS (OPERA I and OPERA II) validate the hypothesis that B cells are central to the underlying biology of the disease.
Top-line data from the ORATORIO study will be presented as a late-breaking abstract at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) by Xavier Montalban, M.D., Ph.D., chair of the Scientific Steering Committee of the ORATORIO study and professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital and Research Institute, Barcelona, Spain on Saturday, October 10th (Abstract #228, 8:52 – 9:03 am CET) in Barcelona, Spain.
Additionally, Phase III results in people with relapsing MS (OPERA I and OPERA II studies) will be presented at ECTRIMS by Stephen Hauser, M.D., chair of the Scientific Steering Committee of the OPERA studies and chair of the Department of Neurology at the University of California San Francisco School of Medicine on Friday, October 9th(Abstract #190, 14:40 – 14:52 pm CET).
Genentech plans to pursue marketing authorization for ocrelizumab in relapsing MS and in PPMS. Data from the OPERA I and II studies and from the ORATORIO study will be submitted to the U.S. Food and Drug Administration in early 2016.
About the ORATORIO study
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