Genentech announced new study analyses from ORCHESTRA, the Phase 3 clinical development program for Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Data will be presented at the 32nd congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on September 14–17, 2016.
The ORCHESTRA program for Ocrevus consists of three Phase 3 studies. OPERA I and OPERA II are identical, randomized, double-blind, double-dummy, global, multicenter trials evaluating the efficacy and safety of Ocrevus 600mg every 6 months vs. interferon beta-1a (Rebif; EMD Serono) 44mcg 3 times a week in 1,656 patients with RMS. ORATORIO is a randomized, double-blind, global, multicenter trial evaluating the efficacy and safety of Ocrevus 600mg every 6 months vs. placebo in 732 patients with PPMS. The composite endpoints are No Evidence of Disease Activity (NEDA) in patients with RMS and No Evidence of Progression (NEP) in patients with PPMS.
New analyses from OPERA I and OPERA II showed that treatment with Ocrevus significantly increased the proportion of RMS patients achieving NEDA by 75% vs. interferon beta-1a over 96 weeks (P<0.0001). NEDA is achieved when a patient presents with no relapses, no confirmed disability progression, no gadolinium-enhancing MRI lesions and no new or enlarging MRI lesions. In addition, Ocrevus significantly increased the relative proportion of patients achieving NEDA by 33% in weeks 0-24 and by 72% in weeks 24-96 (both P<0.0001).
New data from ORATORIO showed that Ocrevus significantly increased the proportion of PPMS patients achieving NEP by 47% vs. placebo at week 120 (P=0.0006). NEP is achieved when a patient presents with no evidence of confirmed disability progression sustained for at least 12 weeks and less than 20% worsening of performance on the timed 25-foot walk and 9-hole peg test.
The most common adverse events associated with Ocrevus in all studies were infusion-related reactions and infections, which were mostly mild to moderate in severity.
The FDA recently accepted with Priority Review the Biologics License Application (BLA) of Ocrevus for the treatment of RMS and PPMS. The agency designated an action date of December 28, 2016 to make a decision on the application.
Ocrevus is a humanized monoclonal antibody that selectively targets CD20-positive B cells.
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