Roche’s Gazyva scores Phase III win in idiopathic nephrotic syndrome

Roche (ROG: SIX) has reported positive top-line results from the Phase III INShore study of Gazyva (obinutuzumab) in children and young adults with idiopathic nephrotic syndrome (INS), adding to the recent momentum following its US approval for lupus nephritis earlier this month.

The trial met its main goal, with significantly more participants on Gazyva achieving sustained complete remission at one year compared with those on mycophenolate mofetil. Key secondary endpoints were also met, showing benefits across relapse-free survival, time to relapse or death, cumulative corticosteroid use and relapse rates. No new safety issues emerged.

Levi Garraway, Roche’s chief medical officer, said the findings suggest Gazyva could deliver durable disease control with less reliance on corticosteroids, which can cause serious long-term effects. He added that idiopathic nephrotic syndrome remains an area of high unmet need, particularly in children.