Roche Pharmaceutical Development and Sales Overview
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
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)
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)
Phase III
ORATORIO
N=732
120-week treatment period:
ARM A: Ocrevus 2x300mg IV every 24 weeks
ARM B: Placebo
Primary endpoint
Annualized relapse rate at 96 weeks
versus Rebif
Annualized relapse rate at 96 weeks
versus Rebif
"
Sustained disability progression versus placebo by EDSS
Primary endpoint met Q2 2015, OLE ongoing
Primary data presented at ECTRIMS 2015
"
Primary endpoint met Q3 2015
CT Identifier
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
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
NCT01247324
Approved in US Q1 2017 and EU Q1 2018
NCT01412333
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;
EAN-European Academy of Neurology; NEJM-New England Journal of Medicine
NCT01194570
00
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