Gazyva Meets Primary Endpoint in Phase III Trial for Primary Membranous Nephropathy

The Phase III MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with Gazyva (obinutuzumab). Results show that significantly more people achieved complete remission at two years (104 weeks) with Gazyva versus tacrolimus. Safety was in line with the well-characterized profile of Gazyva and no new safety signals were identified.

MAJESTY is the first global Phase III study in primary membranous nephropathy. If approved, Gazyva 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 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 U.S. 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 over 96,000 people in the U.S. 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 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.

Primary membranous nephropathy is a chronic autoimmune condition where the body's immune system attacks the filtering units of the kidney, the glomeruli, causing protein to leak into the urine and potentially a gradual decline in kidney function. Over time, the damage to the kidneys can become irreversible, increasing the risk of life-threatening complications, such as kidney failure, idiopathic nephrotic syndrome, blood clots and cardiovascular disease.

MAJESTY is 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. This growing body of evidence supports Gazyva's potential in addressing disease activity across a spectrum of immune-mediated diseases.

Gazyva is approved in the U.S. and European Union 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 is also approved in 100 countries for various types of hematological cancers.

Gazyva (obinutuzumab) is a humanized 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.

MAJESTY [NCT04629248] is a Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of Gazyva (obinutuzumab) in people with primary membranous nephropathy. The study enrolled 142 people who were randomized 1:1 to receive Gazyva or tacrolimus. The primary endpoint is the percentage of people who achieve complete remission at two years (week 104).