Positive phase III results of Genentech’s investigational medicine Ocrevus (ocrelizumab) published in New England Journal of Medicine.
Genentech, a member of the Roche Group, 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 last week in the 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,” Hauser said.
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 and 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.
“Ocrevus is the first and only investigational medicine to significantly reduce the progression of physical disability in primary progressive MS in a large Phase III study,” 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, Research Institute and Cemcat, Barcelona, Spain. “Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for Ocrevus mark an important step in our understanding of this highly disabling form of the disease.”
The Ocrevus safety profile was evaluated in the three Phase III studies. In the RMS studies, the proportion of patients with serious adverse events and serious infections was similar between the Ocrevus and interferon beta-1a treatment groups. In the PPMS study, the proportion of patients with adverse events and serious adverse events was similar between the Ocrevus and placebo treatment groups. Safety analyses continue in the open-label extension studies in both RMS and PPMS.
Marketing applications for Ocrevus, submitted for RMS and PPMS, have been accepted and are currently under review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). As previously announced, Ocrevus was granted Priority Review Designation by the FDA with a targeted action date of March 28, 2017.
Ocrevus is the proprietary name submitted to the FDA for the investigational medicine ocrelizumab.
(Source: Business Wire)