Genentech’s ocrelizumab shows efficacy in phase III trial
pharmafile | September 30, 2015 | News story | Research and Development | Genentech, MS, Roche, ocrelizumab
Roche subsidiary Genentech has announced positive results from a pivotal phase III study of its investigational medicine ocrelizumab in people with primary progressive multiple sclerosis (PPMS).
The double-blind Oratorio study of 732 people 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).
Genentech said the incidence of adverse events associated with ocrelizumab was similar to placebo, with the most commonly-reported being 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,” says Sandra Horning, 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.
MS affects an estimated 2.3 million people worldwide, and occurs when the immune system abnormally attacks the insulation and support around the nerve cells in the brain, spinal cord and optic nerves, causing inflammation and consequent damage.
Initial symptoms typically occur between the age of 20 and 40, making MS the leading cause of non-traumatic disability in younger adults.
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, chair of the Scientific Steering Committee of the Oratorio study and professor of Neurology and Neuroimmunology on October 10.
Genentech plans to pursue marketing authorisation for ocrelizumab in relapsing MS and in PPMS. Data from both Opera studies and from Oratorio will be submitted to the US Food and Drug Administration in early 2016.
Roche was previously forced to abandon ocrelizumab in the treatment of rheumatoid arthritis due to a high incidence of opportunistic infections in participants.
Joel Levy
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