Half-Year 2022 Financial and Clinical Trials Update slide image

Half-Year 2022 Financial and Clinical Trials Update

Ocrevus (ocrelizumab, RG1594) Humanized monoclonal antibody selectively targeting CD20+ B cells Indication Relapsing multiple sclerosis (RMS) Primary progressive multiple sclerosis (PPMS) Phase/study # of patients Design Primary endpoint Status Phase III OPERA I N=821 96-week treatment period: ▪ ARM A: Ocrevus 2x300mg IV followed by 600mg IV every 24 weeks ARM B: Interferon ẞ-1a (Rebif) ▪ Annualized relapse rate at 96 weeks versus Rebif Phase III OPERA II N=835 96-week treatment period: ▪ ARM A: Ocrevus 2x300mg IV followed by 600mg IV every 24 weeks ARM B: Interferon ẞ-1a (Rebif) Annualized relapse rate at 96 weeks versus Rebif " Primary endpoint met Q2 2015, OLE ongoing Primary data presented at ECTRIMS 2015 Phase III ORATORIO N=732 120-week treatment period: " " ARM A: Ocrevus 2x300mg IV every 24 weeks ARM B: Placebo ▪ Updated data presented at AAN and ECTRIMS 2017, AAN and EAN 2018 Data published in NEJM 2017; 376:221-234 Data published on COVID-19 in Mult Scler Relat Disord on Ocrevus treated people with MS, doi.org/10.1016/j.msard.2020.102725 " Sustained disability progression versus placebo by EDSS Primary endpoint met Q3 2015 Primary data presented at ECTRIMS 2015, updated data presented at AAN and ECTRIMS 2017, AAN and EAN 2018 Data published in NEJM 2017; 376:209-220 CT Identifier NCT01247324 ■ Approved in US Q1 2017 and EU Q1 2018 NCT01412333 NCT01194570 IV-intravenous; EDSS-Expanded Disability Status Scale; OLE=Open label extension; ECTRIMS-European Committee for Treatment and Research in Multiple Sclerosis; AAN=Annual Meeting of the American Academy of Neurology; 106 EAN-European Academy of Neurology; NEJM-New England Journal of Medicine Roche Neuroscience
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