Roche’s ocrelizumab first investigational medicine to show positive pivotal study results in both relapsing and primary progressive forms of multiple sclerosis

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The FINANCIAL — Roche on October 8 announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).

Data from two identical studies (called OPERA I and OPERA II) in people with relapsing MS, which affects approximately 85 percent of people with MS at the time of diagnosis, showed ocrelizumab was superior to interferon beta-1a (Rebif), a well-established MS therapy, in reducing the three major markers of disease activity over the two-year controlled treatment period.

In a separate study (called ORATORIO) in people with PPMS, a form of the disease marked by steadily worsening symptoms and typically without distinct relapses or periods of remission, ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks (the primary endpoint) and 24 weeks (a secondary endpoint) compared with placebo. Additionally, the study met other secondary endpoints of reducing the time required to walk 25 feet, the volume of chronic inflammatory brain lesions, and brain volume loss, according to Roche.

“The results of these three pivotal trials have the potential to transform the treatment of MS,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Ocrelizumab is the first investigational medicine to significantly reduce disability progression in people with relapsing MS and people with primary progressive MS – a form of MS with no approved treatments. We are eager to work with regulatory authorities to bring this investigational medicine to the MS community as soon as possible.”

“These results redefine our understanding of MS by highlighting the central role of the B cell,” said 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. “The findings may also encourage the MS community to look more closely at earlier treatment of the disease. Currently, many doctors reserve what are considered highly effective MS medicines until a patient’s disease becomes more advanced. Patients and their doctors need new treatment options that offer the potential for greater efficacy than a standard-of-care interferon with a similar safety profile.”

“This is an important moment for the MS community,” said 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. “For decades, trial after trial has failed to show the benefit of any medicine for people with primary progressive MS. Now, for the first time, we have a positive Phase III study result for people with this debilitating form of the disease.”

Roche plans to pursue marketing authorisation for ocrelizumab in relapsing MS and in PPMS. Data from the ocrelizumab OPERA I and OPERA II studies and from the ORATORIO study will be submitted to global regulatory authorities in early 2016.


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