Roche's Gazyva Meets Primary Endpoint in Phase III Trial for Primary Membranous Nephropathy

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-characterized 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 the company'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.

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. Achieving complete remission is critical to help maintain kidney function and delay or prevent the onset of serious and potentially fatal 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. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

Gazyva/Gazyvaro (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, multicentre study designed to evaluate the efficacy and safety of Gazyva/Gazyvaro (obinutuzumab) in people with primary membranous nephropathy. The study enrolled 142 people who were randomized 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).

In a separate announcement, Roche announced the appointment of a new Head of Roche Pharma Research and Early Development (pRED), effective 1 May 2026. Based in Basel, he will also become a member of the Enlarged Corporate Executive Committee. The new head joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research. A leading expert in cancer biology, his work on chromatin regulation and epigenetics has been instrumental in defining the molecular mechanisms that drive cancer initiation and progression. In addition to his clinical and research leadership, he holds a professorial appointment at the University of Melbourne and is an elected member of the Australian Academy of Science, the Australian Academy of Health and Medical Sciences, and the European Molecular Biology Organisation (EMBO). He earned his medical degree from the University of Melbourne in 1999, followed by specialist training in haematology and a Ph.D. from the University of Cambridge. His career is marked by prestigious international honors, including the Prime Minister's Prize for Science (Life Scientist of the Year, 2020), the Paul Marks Prize for Cancer Research, the William Dameshek Prize (American Society of Hematology), and Howard Hughes International Research Scholar.