Ocrelizumab superior to interferon beta-1a (Rebif) in OPERA I and OPERA II studies for primary progressive MS- Genentech + Roche

Genentech has announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). Data from the ORATORIO study in primary progressive multiple sclerosis was announced on 28 September. The other two comparable studies are called OPERA I and OPERA II in people with relapsing MS, which affects approximately 85% of people with MS at the time of diagnosis.

The OPERA studies showed ocrelizumab was superior to interferon beta-1a (Rebif), a well-established MS therapy, in reducing the three major markers of disease activity over the two-year controlled treatment period. Results from the OPERA I and OPERA II studies will be presented at ECTRIMS 2015 on Friday 9 October (Abstract #246).

OPERA I and OPERA II are Phase III, randomised, double-blind, double-dummy, global multi-centre studies evaluating the efficacy and safety of ocrelizumab (600 mg administered by intravenous infusion every six months) compared with interferon beta-1a (44µg administered by subcutaneous injection three times per week) in 1,656 people with relapsing forms of MS (i.e. relapsing-remitting MS and secondary-progressive MS with relapses). In the OPERA I and OPERA II studies, ocrelizumab significantly reduced the annualised relapse rate (ARR) – the primary endpoint of both studies – by nearly 50% compared with interferon beta-1a over the two-year period. Additionally, ocrelizumab met secondary endpoints of the study, significantly delaying confirmed disability progression (CDP; loss of physical abilities, measured by the Expanded Disability Status Scale, or EDSS) by approximately 40% sustained for both 12 and 24 weeks compared with interferon beta-1a in pre-specified, pooled analyses of the two studies (p=0.0006 and 0.0025, respectively). Ocrelizumab also significantly reduced acute MS-related inflammation and brain injury (total number of T1-gadolinium-enhancing lesions measured by magnetic resonance imaging, or MRI) at 24, 48 and 96 weeks by more than 90% and the emergence of more chronic or growing areas of MS-related brain injury (T2 hyperintense lesions) at 24, 48 and 96 weeks by around 80% compared with interferon beta-1a.

Overall, the proportion of patients in the ocrelizumab group with adverse events was similar to interferon beta-1a in a pooled analysis of both studies (83% in each treatment group).