June 30, 2015 | By Márcio Barra
Genentech, a member of the Roche Group, announced today that its Multiple Sclerosis (MS) agent Ocrelizumab, for people with relapsing multiple sclerosis, met its main endpoints in two final-stage Phase III clinical trials (the OPERA I and OPERA II studies)
Ocrelizumab is a humanized anti-CD20 monoclonal antibody that acts as a suppressor of CD20-positive B cells, a type of cell thought to be behind myelin destruction in MS. Other monoclonal antibody treatments for MS include Daclizumab (currently in clinical trial phase) and Alemtuzumab (commercialized as Lemtrada).
The OPERA I and OPERA II phase III studies recruited a total of 1656 participants with relapsing remitting MS who took either ocrelizumab 600mg every 6 months or interferon beta 1a (Rebif, an injectable MS treatment marketed by Merck Serono) three times per week for approximately two years. Both studies shared the same set of endpoints. Primary endpoint was annualized protocol-defined relapse rate (ARR) at two years (96 weeks). Secondary endpoints included time to onset of confirmed disability progression, and safety related endpoints such as the total number of T1 Gadolinium-enhancing lesions, and total number of new and/or enlarging T2 hyperintense lesions as detected by brain MRI.
In the press release, Roche stated that ocrelizumab “significantly reduced” relapses, alongside a reduction of disability progression compared with Rebif, as measured by the Expanded Disability Status Scale (EDSS), the standard MS evaluation tool.
Regarding the safety endpoints, Roche stated the drug showed a similar number of adverse effects as Rebif, the most common being infusion-related reactions involving the immune system. Ocrelizumab infusion also led to a significant reduction in the number of lesions in the brain compared with Rebif, as observed by MRI scans.
However, no “real” results were shared by Roche, as the company declared that further analyses of the OPERA studies are ongoing, and detailed data will be presented at an upcoming medical congress. Roche is also preparing to start filling for regulatory approval in 2016, according to Sandra Horning, M.D., chief medical officer and head of Global Product Development:
“Ocrelizumab showed remarkable improvements over a standard-of-care medicine across clinical and imaging endpoints in two pivotal studies. Ocrelizumab has the potential to make a meaningful difference for people with MS, a chronic and debilitating disease. Based on these compelling results, we plan to submit the data for review to U.S. and EU regulatory authorities in the first quarter of 2016.”
Alongside the OPERA studies, Ocrelizumab is also being studied in a currently ongoing Phase III clinical study entitled ORATORIO, a placebo-controlled study in people with Primary Progressive Multiple Sclerosis.