Genentech, a member of the Roche Group, has announced that its Phase III MAJESTY trial evaluating Gazyva (obinutuzumab) in adults with Primary Membranous Nephropathy (PMN) successfully met its primary endpoint.
The study demonstrated that a significantly higher proportion of patients treated with Gazyva achieved complete remission at two years (104 weeks). The safety profile of Gazyva remained consistent with previously reported data, with no new safety signals identified.
Levi Garraway, Chief Medical Officer and Head of Global Product Development at Genentech, said the findings highlight Gazyva’s potential to help more patients achieve sustained remission, preserve kidney function and delay or prevent life-threatening complications associated with PMN. He added that, if approved, Gazyva would become the first therapy specifically indicated for primary membranous nephropathy, a condition with limited treatment options.
In addition to meeting the primary endpoint, the trial demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints. These included higher overall remission rates (complete or partial remission) at week 104 and improved complete remission rates at week 76 compared with tacrolimus.
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