Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy

Roche has recently announced that the phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva/Gazyvaro. Results show that significantly more people achieved complete remission at two years with Gazyva/Gazyvaro versus tacrolimus.

“These results demonstrate that Gazyva/Gazyvaro may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “If approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.”

Note that primary membranous nephropathy is a chronic autoimmune condition that causes potentially irreversible kidney damage and reduced kidney function, and it is estimated that it affects  nearly 88,000 people in the EU and over 96,000 in the US. Up to 30% of people with primary membranous nephropathy will develop kidney failure over 10 years, which requires invasive intervention like dialysis or transplant and has a significant impact on patients and their families, as well as carrying substantial cost to health systems.

In addition, the MAJESTY is the fourth positive phase III study of Gazyva/Gazyvaro in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus and INShore in idiopathic nephrotic syndrome. This growing body of evidence supports Gazyva/Gazyvaro’s potential in addressing disease activity across a spectrum of immune-mediated diseases.

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Related Topics and Keywords

Gazyva/Gazyvaro, membranous nephropathy, Roche