Roche Pharmaceutical Development and Sales Overview
Ocrevus (ocrelizumab, RG1594)
Humanized monoclonal antibody selectively targeting CD20+ B cells
Indication
Primary progressive multiple sclerosis
(PPMS)
Relapsing multiple sclerosis (RMS)
Phase/study
# of patients
Design
Primary endpoint
Status
CT Identifier
Phase IIIb
GAVOTTE
N-699
Phase IIIb
MUSETTE
N-786
PPMS & RMS
Phase III
Ocarina II1
N-232
120-week treatment period:
ARM A: Ocrevus 600mg IV every 24 weeks
ARM B: Ocrevus 1200mg if body weight
<75kg or 1800mg if body weight > or equal
to 75kg every 24 weeks
Superiority of Ocrevus higher dose versus
approved dose on CCDP
FPI Q4 2020
"
"
120-week treatment period:
ARM A: Ocrevus 600mg IV every 24 weeks
ARM B: Ocrevus 1200mg if body weight <75kg or
1800mg if body weight > or equal to 75kg every
24 weeks
ARM A: Ocrevus IV
ARM B: Ocrevus SC
Superiority of Ocrevus higher dose versus
approved dose on CCDP
FPI Q4 2020
Recruitment completed Q4 2021
Serum Ocrevus area under the concentration-
time curve (AUCW1-12) at week 12
FPI Q2 2022
NCT04548999
1SC with Halozyme's rHuPH20/ Halozyme's human hyaluronidase
CCDP-composite confirmed disability progression; IV-intravenous; SC-Subcutaneous
NCT04544436
NCT05232825
98
86
Roche
NeuroscienceView entire presentation