Pharma Update
Gazyva with best-in-disease potential in lupus nephritis
Potential benefit in autoimmune diseases through sustained B cell depletion
Gazyva
(glycoengineered anti-CD20 mAb)
Ph II (NOBILITY) results in LN1
Complete renal response
Clinical trial program
Type II anti-CD20 region
50%
•
Increased direct cell death
Decreased CDC
.
Reduced internalization
Indication
Phl
Ph II
Ph III
p<0.05
p<0.05
40%
p<0.2
LN
REGENCY
40%
41%
30%
35%
MN
MAJESTY
20%
23%
23%
18%
Glycoengineered Fc region
10%
SLE
ALLEGORY
•
Higher FCYR affinity
0%
Increased ADCC/ADCP
Week 52
Week 76
Week 104
INS
INShore
Gazyva + MMF
Placebo + MMF
Roche
·
Greater potency than Rituxan in depleting
•
peripheral and tissue B-cells
Ph II (NOBILITY) in LN met both primary and key secondary endpoints with no new safety signals;
Placebo-corrected CRR of 22% at week 762,3
•
Studies suggest that tissue based B-cells play a
⚫
Ph III (REGENCY) in LN fully recruited with results expected in 2024
major role in lupus nephritis
•
MN, SLE and INS: Complementary indications of the Gazyva program, with best-in-disease potential in
MN, SLE and childhood onset INS
1. Furie R, et al. Ann Rheum Dis 2022; 81:100-107; 2.Furie R et al. Lupus Science & Medicine 2020;7 (Suppl 1):A27; 3.Furie R. et al; ACR 2019; mAb-monoclonal antibody; LN-lupus nephritis; MMF=mycophenolate mofetil;
MN=membranous nephropathy; SLE-systemic lupus erythematosus; INS-Idiopathic nephrotic syndrome (Childhood onset INS also known as PNS-Pediatric nephrotic syndrome); CDC=complement-dependent cytotoxicity;
ADCC-antibody-dependent cell-mediated cytotoxicity; ADCP-antibody-dependent cellular phagocytosis; CRR=complete renal response; IV-intravenous
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