Roche Touts MS Drug Ocrelizumab Results in Two Phase 3 Trials
Roche announced positive results from two Phase 3 studies pitting its investigational multiple sclerosis drug ocrelizumab against the standard-of-care in patients with relapsing MS, the most common form of the disease.
The studies met their primary and major secondary endpoints, the firm said.
Treatment with ocrelizumab significantly reduced the relapse rate of MS over a two-year period compared with interferon beta-1a, the primary endpoint in both studies. It also significantly reduced the progression of clinical disability as measured by the Expanded Disability Status Scale, and reduced the number of lesions in the brain compared with interferon beta-1a, the Swiss drugmaker said.
The studies — which enrolled 1,656 people with relapsing MS across 307 sites in 40 countries — also showed the occurrence of adverse events was similar to the control, with the most common being mild to moderate infusion-related reactions, Roche said.
Roche will submit the data to the FDA and European Medicines Agency in support of an approval application in the first quarter of 2016, said Sandra Horning, chief medical officer and head of global product development.
An additional Phase 3 study of ocrelizumab in patients with primary progressive MS is also underway, with results expected later this year. — Kellen Owings