South San Francisco, California — February 16, 2026 — Leads & Copy — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the Phase III MAJESTY study of Gazyva® (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint.
The study showed statistically significant and clinically meaningful results, with significantly more people achieving complete remission at two years (104 weeks) with Gazyva versus tacrolimus. The safety profile of Gazyva was consistent with previous findings, and no new safety signals were identified.
Dr. Levi Garraway, chief medical officer and head of Global Product Development, stated that the results demonstrate Gazyva’s potential to help more people with primary membranous nephropathy achieve complete remission, maintain kidney function longer, and delay or prevent life-threatening complications. If approved, Gazyva would be the first therapy specifically indicated for primary membranous nephropathy, where treatment options are limited.
Analysis of key secondary endpoints revealed statistically significant and clinically meaningful benefits with Gazyva compared to tacrolimus in overall remission (complete or partial) at week 104 and complete remission at week 76.
The 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 affecting an estimated 96,000 people in the U.S. It causes potentially irreversible kidney damage and reduced kidney function. Up to 30% of those affected develop kidney failure within 10 years, requiring interventions like dialysis or transplant.
Gazyva targets an underlying cause of the condition, potentially helping to maintain kidney function longer and prevent life-threatening complications. 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.
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. Genentech has a broad pipeline in immunology, focused on immune-mediated and kidney-related diseases.
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 increased antibody-dependent cellular cytotoxicity (ADCC). It is approved for adults with lupus nephritis in the US and EU and in 100 countries for various types of hematological cancers.
The MAJESTY study [NCT04629248] is a Phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of Gazyva 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).
Primary membranous nephropathy is a chronic autoimmune condition where the body’s immune system attacks the filtering units of the kidney, 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.
GAZYVA® (obinutuzumab) is a prescription medicine used to treat chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and active lupus nephritis (LN) in adults.
Patients should inform their doctor about any side effects, including Hepatitis B Virus (HBV), Progressive Multifocal Leukoencephalopathy (PML), allergic reactions, Infusion-Related Reactions, Hypersensitivity Reactions Including Serum Sickness, Tumor Lysis Syndrome (TLS), Serious Infections, Low White Blood Cell Count, Low Platelet Count, and Disseminated Intravascular Coagulation (DIC).
Before receiving GAZYVA, patients should discuss immunizations, pregnancy, and breastfeeding with their doctor.
Genentech is committed to addressing unmet needs for patients with immune-mediated inflammatory diseases, with a pipeline of over a dozen clinical programs in immunology.
Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.
Source: Genentech
