OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ORATORIO study in primary progressive multiple sclerosis (PPMS) are published in NEJM.- Genentech/Roche

Genentech, a member of the Roche Group announced that data from three Phase III studies of its investigational medicine Ocrevus (ocrelizumab) � the OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ORATORIO study in primary progressive multiple sclerosis (PPMS) � were published in the December 21, 2016 online issue of the New England Journal of Medicine (NEJM).

Data from the Ocrevus Phase III studies showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif (interferon beta-1a) in RMS and with placebo in PPMS. The primary endpoint was met in all three studies, which includes relative reduction of annualized relapse rate in the RMS studies and relative reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study. Key secondary endpoints in all three studies were also met, including multiple measures of disability progression and brain lesion activity.

Data from two identical studies (OPERA I and OPERA II) in RMS showed Ocrevus was superior to high-dose Rebif (interferon beta-1a), a well-established MS therapy, in reducing three major markers of disease activity: relapses (primary endpoint), disability progression, brain lesion activity over the two-year controlled treatment period. In a separate PPMS study (ORATORIO), Ocrevus significantly reduced the risk of confirmed disability progression sustained for at least 12 weeks (primary endpoint) and 24 weeks (a key secondary endpoint) compared with placebo. Ocrevus treatment was also superior to placebo on other key measures of disease progression in PPMS patients including the time required to walk 25 feet, the volume of chronic brain lesions and brain volume loss.

See- "Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis"- Xavier Montalban, M.D., Stephen L. Hauser, M.D., Ludwig Kappos, M.D., Douglas L. Arnold, M.D., et.,al. for the ORATORIO Clinical Investigators December 21, 2016DOI: 10.1056/NEJMoa1606468.

See-"Ocrelizumab versus Interferon Beta-1a in Relapsing Multiple Sclerosis"-Stephen L. Hauser, M.D., Amit Bar-Or, M.D., Giancarlo Comi, M.D., Gavin Giovannoni, M.D., Hans-Peter Hartung, M.D. et.,al. for the OPERA I and OPERA II Clinical Investigators December 21, 2016DOI: 10.1056/NEJMoa1601277.