By: IPP Bureau
Last updated : October 30, 2025 10:26 am
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva
Roche announced statistically significant and clinically meaningful results from the Phase III INShore study evaluating Gazyva (obinutuzumab) in children and young adults aged 2 to 25 years with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, showing that a significantly higher proportion of patients treated with Gazyva achieved sustained complete remission at one year (week 52) compared with those receiving mycophenolate mofetil (MMF). Sustained complete remission was defined as the absence of relapses throughout the study and a protein-to-creatinine ratio of 0.2 or less at week 52.
Key secondary endpoints also demonstrated statistically significant and clinically meaningful benefits with Gazyva, including improvements in relapse-free survival, median time to relapse or death, reduction in cumulative corticosteroid dose from baseline to week 52, and fewer relapses compared with MMF. No new safety signals were identified, and the safety profile was consistent with that previously established in adults.
“These results show that Gazyva may achieve robust disease control with a reduced need for corticosteroids, which are associated with serious long-term side effects,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Idiopathic nephrotic syndrome is a severe and chronic kidney disease often diagnosed in early childhood, yet meaningful treatment progress has remained limited. As a targeted therapy, Gazyva has the potential to address this significant unmet medical need, and we look forward to sharing the data with health authorities.”
For decades, treatment for idiopathic nephrotic syndrome has primarily relied on steroids, but relapse rates remain high and long-term steroid use is associated with serious adverse effects. Newer therapeutic approaches that target specific immune cells—such as B cells, which are believed to drive disease activity—may offer a more effective and sustainable way to manage symptoms and maintain remission.
The INShore study is the first global Phase III trial evaluating a targeted therapy in idiopathic nephrotic syndrome, a chronic kidney disease most commonly diagnosed in early childhood. Data from the study will be presented at an upcoming medical meeting and shared with health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The INShore results add to a growing body of evidence, including data from the Phase III REGENCY study in lupus nephritis, demonstrating that targeting disease-causing B cells with Gazyva may help reduce disease activity across a range of immune-mediated kidney and kidney-related conditions. In October 2025, Gazyva was approved in the United States for the treatment of adults with active lupus nephritis receiving standard therapy, based on findings from the REGENCY and NOBILITY studies.