Biotechnology company Genentech, a member of the Roche Group (SIX: RO, ROG) (OTCQX: RHHBY), on Monday reported positive Phase III results from the MAJESTY study evaluating Gazyva (obinutuzumab) in adults with primary membranous nephropathy.

MAJESTY, the first global Phase III study in this indication, met its primary endpoint, with significantly more patients achieving complete remission at two years (104 weeks) compared with tacrolimus. Key secondary endpoints, including overall remission at week 104 and complete remission at week 76, also demonstrated statistically significant and clinically meaningful benefits. Safety profile was consistent with established data, with no new safety signals identified.

Primary membranous nephropathy is a chronic autoimmune kidney disease affecting an estimated 96,000 people in the United States. Up to 30% of patients progress to kidney failure within 10 years despite current treatments, often requiring dialysis or transplantation. Achieving complete remission is considered critical to delaying or preventing irreversible kidney damage.

Gazyva, a glycoengineered anti-CD20 monoclonal antibody designed for deep tissue B cell depletion, could become the first approved therapy for primary membranous nephropathy. Data will be presented at an upcoming medical meeting and submitted to regulators including the U.S. Food and Drug Administration and the European Medicines Agency.

MAJESTY enrolled 142 patients in a randomised, open-label, multicentre design. Study represents the fourth positive Phase III programme for Gazyva in immune-mediated diseases, following REGENCY in lupus nephritis, ALLEGORY in systemic lupus erythematosus and INShore in idiopathic nephrotic syndrome.

Gazyva is approved in the United States and European Union for adults with active lupus nephritis and in more than 100 countries for certain haematological cancers.