Roche Pharmaceutical Development and Sales Overview
Gazyva (obinutuzumab, RG7159)
Immunology development program
Indication
Lupus nephritis
Membranous nephropathy
Roche
Phase/study
# of patients
Design
Phase II
NOBILITY
N=126
ARM A: Gazyva 1000mg IV plus mycophenolate
mofetil/mycophenolic acid
ARM B: Placebo IV plus mycophenolate mofetil/
mycophenolic acid
Phase III
REGENCY
N=252
ARM A: Gazyva 1000mg IV (6 doses through
Week 52) plus mycophenolate mofetil
ARM B: Gazyva 1000 mg IV (5 doses through
Week 52) plus mycophenolate mofetil
ARM C: Placebo IV plus mycophenolate
mofetil
"
Phase III
MAJESTY
N=140
ARM A: Gazyva 1000mg IV dosed at baseline
and weeks 0, 2, 24, and 26 on top of renin-
angiotensin inhibitors
ARM B: Tacrolimus treatment for 12 months
Primary endpoint
Percentage of participants who achieve complete
renal response (CRR)
Recruitment completed Q4 2017
"
Primary endpoint met Q2 2019
ā
BTD granted by the FDA Q3 2019
Status
CT Identifier
Data presented at ASN and ACR 2019
Published in Ann Rheum Dis 2022 Jan;81(1):100-
107
NCT02550652
Percentage of participants who achieve
complete renal response (CRR)
ā
FPI Q3 2020
Percentage of patients who achieve complete
remission at week 104
FPI Q2 2021
NCT04221477
In collaboration with Biogen
BTD=Breakthrough therapy designation; IV=Intravenous; ASN=American Society of Nephrology; ACR=American College of Rheumatology
NCT04629248
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ImmunologyView entire presentation