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
NeuroscienceView entire presentation