Genentech's Gazyva Meets Primary Endpoint In Idiopathic Nephrotic Syndrome Phase III Trial

(RTTNews) - Genentech, a member of the Roche Group (RHHBY), announced that its Phase III INShore study evaluating Gazyva (obinutuzumab) in children and young adults aged 2 to 25 years with idiopathic nephrotic syndrome (INS) achieved statistically significant and clinically meaningful results.

The study met its primary endpoint, with more participants achieving sustained complete remission at one year (week 52) with Gazyva compared to mycophenolate mofetil (MMF). Sustained complete remission was defined as the absence of relapses and a urine protein-to-creatinine ratio of 0.2 or less at week 52. Several key secondary endpoints were also met.

No new safety signals were identified, and the safety profile remained consistent with Gazyva's established use in adults.

In addition to idiopathic nephrotic syndrome, Gazyva is being investigated in membranous nephropathy, lupus nephritis, rare immune-mediated kidney diseases and systemic lupus erythematosus.

Gazyva is also approved in 100 countries for various types of hematological cancers. In the U.S., Gazyva is part of a collaboration between Genentech and Biogen.

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