Roche's Gazyva Meets Primary Endpoint in Phase III Kidney Disease Trial

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.

The MAJESTY study, the first global phase III study in primary membranous nephropathy, enrolled 142 people who were randomised 1:1 to receive Gazyva/Gazyvaro or tacrolimus. The primary endpoint is the percentage of people who achieve complete remission at two years (week 104). 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.

The Chief Medical Officer and Head of Global Product Development stated that if approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options. The 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.

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. Roche plans regulatory submissions in the US and EU.

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 membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this. The condition 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.

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. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

Gazyva/Gazyvaro (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC). CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is a glycoengineered, anti-CD20 monoclonal antibody designed to achieve deep tissue B cell depletion and has the potential to address primary membranous nephropathy by targeting an underlying cause of the condition, which may help maintain kidney function for longer and prevent the onset of life-threatening complications.