Roche Pharmaceutical Development and Sales Overview
MS franchise: Subcutaneous dosing and higher dose Ocrevus
Q6M SC dosing readout expected in 2023
Ocrevus SC will retain Q6M dosing
Administration and observation schedule
Total time
Regular IV
IV pre-
medication 30-
60 min
Shorter IV
=Infusion
=Observation
Roche
OCREVUS
ocrelizumab
Ocrevus higher dose vs 600 mg in RMS and PPMS
Double-blind treatment (min. of ≥120 weeks)
Ocrevus higher dose 1,200/1,800 mg
Additional
5.5-6h
enen
Dose 1
3.5-4h
Screening
2:1
Dose 2 Dose 3 Dose 4
Ocrevus 600 mg
Dose 5
doses of
blinded
treatment
Onon On
et
Dose 1
Dose 2
Dose 3 Dose 4
Dose 5
Additional
doses of
blinded
treatment
Primary
analysis
~1h
SC injection
Oral pre-
medication*
Dose 1-2
10min+
Dose >2
*1-2 h pre injection
=Infusion
|=Observation (first two doses only)*
⚫ Ph III (OCARINA II) evaluating subcutaneous Q6M dosing of Ocrevus for non-
inferiority vs Ocrevus IV in RMS & PPMS with data expected in 2023
•
Increases potential for Ocrevus use in centers with IV capacity constraints
.
Open label treatment (total of 96 weeks)
Ocrevus higher dose 1,200/1,800 mg
Safety Follow Up
Dose 1
Dose 2
Dose 3
Dose 4
B-Cell Monitoring
Two double-blind, randomized Ph III studies were designed to test
higher dose Ocrevus (MUSETTE in RMS and GAVOTTE in PPMS)1
Exposure/response analysis of Ph III data suggests a higher dose could
lower the risk of disability progression without compromising safety
1 Hauser S.L. et al, ACTRIMS-ECTRIMS 2020; *Expected, but may vary based on clinical results; MS-multiple sclerosis; IV-intra-venous; SC-Subcutaneous; RMS=relapsing multiple sclerosis; PPMS=primary progressive MS;
Q6M-dosing every 6 months
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