Positive Phase III Results of Genentech’s Investigational Medicine Ocrevus™ (Ocrelizumab) Published in New England Journal of Medicine
- OCREVUS is the first and only investigational medicine to show superior efficacy versus comparators in both relapsing and primary progressive multiple sclerosis in clinical studies
- OCREVUS demonstrated a favorable safety profile in three large Phase III studies
South San Francisco, CA -- December 21, 2016 --
SOUTH SAN FRANCISCO, Calif. – December 21, 2016 – Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today 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.
“These publications that indicate that B cells play a central role in MS are the result of a longstanding collaboration between the scientific community and industry for the benefit of people with MS,” said Stephen Hauser, M.D., Chair of the Scientific Steering Committee of the OPERA studies, Director of the Weill Institute for Neurosciences and Chair of the Department of Neurology at the University of California, San Francisco. “In the OPERA I and OPERA II RMS studies, OCREVUS consistently and significantly reduced disease activity and disability progression compared with a standard-of-care high-dose interferon while demonstrating a favorable safety profile. The consistency of these pioneering data, the effect seen in these clinical studies and the favorable safety profile may support treating MS earlier with a high-efficacy disease-modifying medicine.”