- Gazyva met primary endpoint in phase III INShore study for idiopathic nephrotic syndrome.
- Study involved children and young adults aged 2-25 years.
- No new safety signals identified; safety profile consistent with adult use.
- Data to be presented to US FDA and European Medicines Agency.
Study Overview
Roche announced significant results from the phase III INShore study of Gazyva (obinutuzumab) in children and young adults with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, showing more patients achieved sustained complete remission at week 52 compared to mycophenolate mofetil (MMF).
Patient Impact
Gazyva may help reduce the need for corticosteroids, which are linked to serious side effects. The study involved participants aged 2-25 years, and no new safety signals were identified, aligning with the known safety profile in adults.
Secondary Endpoints
Key secondary endpoints showed benefits with Gazyva, including increased relapse-free survival, longer median time to relapse or death, reduced cumulative corticosteroid dose, and fewer relapses compared to MMF.
Regulatory Plans
Data from the study will be presented at an upcoming medical meeting and shared with health authorities, including the US FDA and the European Medicines Agency.
Broader Implications
INShore data add to evidence from other studies, like the phase III REGENCY study in lupus nephritis, suggesting that targeting B cells with Gazyva may address disease activity in various immune-mediated kidney diseases.
