Genentech, part of the Roche Group, announced that the Phase III MAJESTY study in adults with primary membranous nephropathy successfully met its primary endpoint, demonstrating statistically significant and clinically meaningful results with Gazyva (obinutuzumab). The trial showed that a significantly higher number of patients achieved complete remission at 104 weeks compared with those treated with tacrolimus. The safety profile of Gazyva was consistent with previous studies, and no new safety concerns were identified.
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Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development at Genentech, emphasized that these results indicate Gazyva may enable more patients to reach complete remission, maintain kidney function for longer periods, and potentially prevent serious complications associated with the disease. He noted that if approved, Gazyva could become the first therapy specifically indicated for primary membranous nephropathy, offering a new treatment option for a condition with limited available therapies.
Secondary endpoints also showed statistically significant and clinically meaningful improvements with Gazyva versus tacrolimus, including overall remission at week 104 and complete remission at week 76. The company plans to present the full data at an upcoming medical conference and share it with regulatory agencies such as the U.S. Food and Drug Administration and the European Medicines Agency.
Primary membranous nephropathy is a chronic autoimmune disease that can lead to irreversible kidney damage and reduced kidney function, affecting more than 96,000 people in the United States. Up to 30 percent of patients may progress to kidney failure within ten years, requiring dialysis or transplant and placing significant burden on patients, families, and healthcare systems. Gazyva targets the underlying cause of the condition, potentially delaying disease progression and preventing life-threatening complications.
The MAJESTY trial represents the fourth positive Phase III study of Gazyva in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus, and INShore in idiopathic nephrotic syndrome. These studies build a growing body of evidence supporting Gazyva’s potential across a spectrum of immune-mediated disorders. Gazyva is already approved in the United States and European Union for adults with active lupus nephritis and is being evaluated in a global Phase II study in children and adolescents. Beyond Gazyva, Genentech continues to develop a broad pipeline focused on immunology, particularly in immune-mediated and kidney-related conditions.
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