Genentech, which is part of the Roche Group, announced that its Phase III INShore study of Gazyva (obinutuzumab) for children and young adults aged 2 to 25 with idiopathic nephrotic syndrome (INS) has reached its main goal. The results show that patients who received Gazyva were more likely to stay in complete remission for one year compared to those who took mycophenolate mofetil (MMF). Complete remission was measured as no signs of the disease returning and low levels of urine protein at week 52. Several important secondary outcomes were also positive, and there were no new safety issues. The safety of Gazyva was similar to what has been seen in adults.
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“These findings suggest that Gazyva could offer strong disease control and help reduce the need for long-term corticosteroid use, which can have serious side effects,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech. “Idiopathic nephrotic syndrome is a serious and often long-term kidney condition that usually starts in early childhood, but treatment options have been limited. As a targeted therapy, Gazyva may provide a new treatment option for this unmet need, and we are looking forward to sharing these results with regulatory bodies,” he added.
For many years, the standard treatment for idiopathic nephrotic syndrome has been corticosteroids, but relapses are common, and long-term use is limited due to harmful side effects. New treatments that target specific immune cells, like B cells that are involved in the disease, could offer better management of symptoms and better long-term results.
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Looking at the secondary outcomes from the INShore trial showed more benefits of Gazyva, including a higher chance of staying relapse-free, longer time before a relapse or death, less corticosteroid use from the start to week 52, and fewer relapses compared to MMF. Some other secondary outcomes did not show big differences between the two groups. Genentech plans to share the full data at upcoming medical meetings and send the results to health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency.
The INShore trial follows evidence from the Phase III REGENCY study in lupus nephritis, showing that Gazyva can help control disease-causing B cells and treat autoimmune kidney conditions. In October 2025, Gazyva was approved in the U.S. for adults with active lupus nephritis who are already on standard treatment, based on results from the REGENCY Phase III and NOBILITY Phase II studies. In addition to idiopathic nephrotic syndrome, Gazyva is being studied for membranous nephropathy, lupus nephritis, rare immune-related kidney disorders, and systemic lupus erythematosus. Genentech aims to lead in developing treatments for immune-related kidney diseases and related conditions, offering new options for patients facing difficult health challenges.
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