Roche’s Phase III MAJESTY Study Shows Gazyva Superior To Tacrolimus In Primary Membranous Nephropathy

Roche announced that its Phase III MAJESTY study evaluating Gazyva®/Gazyvaro® (obinutuzumab) in adults with primary membranous nephropathy (PMN) achieved its primary endpoint. The study demonstrated that significantly more patients treated with Gazyva/Gazyvaro reached complete remission at two years (104 weeks) compared with those receiving tacrolimus. The safety profile was consistent with the established profile of Gazyva/Gazyvaro, and no new safety concerns were identified.

Key secondary endpoints also showed statistically significant and clinically meaningful improvements. Patients treated with Gazyva/Gazyvaro achieved higher overall remission rates (complete or partial) at Week 104 and higher complete remission rates at Week 76 than those treated with 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.”

Primary membranous nephropathy is a chronic autoimmune kidney disease that can lead to progressive and irreversible kidney damage. It affects an estimated 88,000 people in the European Union and over 96,000 in the United States. Up to 30% of patients may develop kidney failure within 10 years, requiring dialysis or kidney transplantation. By targeting an underlying cause of the disease, Gazyva/Gazyvaro has the potential to help preserve kidney function and delay or prevent life-threatening complications.

MAJESTY marks the fourth positive Phase III study of Gazyva/Gazyvaro in immune-mediated diseases. Previous successful trials include REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus, and INShore in idiopathic nephrotic syndrome. The therapy is already approved in the US and EU for adults with active lupus nephritis based on data from REGENCY and NOBILITY, and it is currently being evaluated in a global Phase II study in pediatric lupus nephritis. Roche stated that these results further strengthen its immunology pipeline, particularly in immune-mediated and kidney-related diseases.