Ocrelizumab: Additional Phase III data

Additional data from the double-blind, double-dummy, international Phase III OPERA I trial in 821 RRMS patients showed that 300 mg IV ocrelizumab on day 1 and 15 of the first 24-week cycle followed by 600 mg ocrelizumab on day 1 of each cycle thereafter reduced ARR, the primary endpoint, by 46% from baseline to week 96 vs. Rebif interferon beta-1a (p<0.0001). On secondary endpoints, ocrelizumab reduced the progression of clinical disability sustained for >=12 weeks as measured by EDSS score by 43% (p=0.0139) and for >=24 weeks by 43% (p=0.0278) vs. Rebif. Ocrelizumab also reduced the total number of T1 gadolinium-enhancing lesions by 94% (p<0.0001) and the total number of new and/or newly enlarging T2 hyperintense lesions by 77% (p<0.0001) vs. Rebif. Data were presented at the European Committee for Treatment and Research in Multiple Sclerosis meeting in Barcelona. Previously reported data showed that ocrelizumab met the primary endpoint (see BioCentury, July 13). ...