Positive new data from Phase 3 clinical trials assessing Ocrevus (ocrelizumab) as a treatment for both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS) were recently announced by Roche, the company responsible for marketing and developing this investigational therapy.
The results are being presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), taking place in London on Sept. 14–17. A complete list of presentations regarding the results of the trial can be found here.
The Phase 3 clinical program for Ocrevus is composed of three studies, OPERA I and OPERA II (NCT01412333), and the ORATORIO trial. The first two are evaluating outcomes in relapsing MS patient using No Evidence of Disease Activity (NEDA) as a parameter. NEDA is achieved when there are no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions, and no new or enlarging MRI lesions.
In OPERA, 600 mg of Ocrevus were administered intravenously every six months, and its effects compared to that of Rebif (interferon beta-1a) in more than 1,600 RRMS patients. Researchers in the pooled-data analyses found that Ocrevus treatment significantly increased the proportion of relapsing MS patients achieving NEDA in comparison to interferon beta-1a. In the first 24 weeks of the study, 60.8% of patients receiving Ocrevus reached NEDA; this proportion increased to 72.2% during weeks 24–96.
ORATORIO (NCT01194570) evaluated the efficacy and safety of Ocrevus in 732 patients with PPMS, with effectiveness measured by No Evidence of Progression (NEP). This parameter looks at three measures of physical disability — confirmed disease progression, walking speed, and upper extremity function — and reflects no evidence of worsening disability. Post-hoc analyses showed that, compared to the placebo, Ocrevus treatment (600 mg intravenous injection every six months) significantly increased the proportion of PPMS patients (47%) with NEP at almost two years of treatment (120 weeks).
In all studies, the most frequent side effects were mild to moderate reactions and infections related to the treatment’s injection.
“These new data suggest that ocrelizumab consistently impacts disease progression and has the potential to change how we approach treating both relapsing and primary progressive MS,” Professor Gavin Giovannoni, with the committee for the OPERA studies, said in a news release.
Ocrevus exerts its effect by targeting CD20-positive B-cells, a type of immune system cells believed to contribute to myelin degeneration and neuronal damage, the hallmarks of MS.
“With no approved treatment options, primary progressive MS remains a challenge for physicians and people with MS,” said Xavier Montalban, MD, PhD, a professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital, Research Institute and Cemcat, in Barcelona, Spain. “OCREVUS significantly impacted three key disability measurements, which further highlight its clinical significance in people with primary progressive MS.”
According to Roche, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have accepted marketing applications for Ocrevus, each submitted for RRMS and PPMS.
The drug is being developed in the U.S. through Genentech, a wholly owned member of the Roche Group.