Roche 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® (obinutuzumab).
Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva/Gazyvaro versus tacrolimus. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro and no new safety signals were identified.
“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.”
Analysis of key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro versus tacrolimus in overall remission (complete or partial remission) at week 104 and complete remission at week 76.
Data will be presented at an upcoming medical meeting and shared with health authorities including the US Food and Drug Administration and the European Medicines Agency.
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. Gazyva/Gazyvaro has the potential to address this by targeting an underlying cause of the condition, which may help maintain kidney function for longer and prevent the onset of life-threatening complications.
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.
Gazyva/Gazyvaro is approved in the US and EU for the treatment of adults with active lupus nephritis based on data from the REGENCY and NOBILITY studies and is being investigated in a global phase II study of children and adolescents with lupus nephritis.
