Half-Year 2022 Financial and Clinical Trials Update slide image

Half-Year 2022 Financial and Clinical Trials Update

Gazyva (obinutuzumab) 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 Status Percentage of participants who achieve complete renal response (CRR) ▪ Recruitment completed Q4 2017 Primary endpoint met Q2 2019 ■ BTD granted by the FDA Q3 2019 Data presented at ASN and ACR 2019 ■ Published in Ann Rheum Dis 2022 Jan;81(1):100- 107 CT Identifier NCT02550652 Percentage of participants who achieve complete renal response (CRR) 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 113 Immunology
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