Roche Reports Positive Phase III MAJESTY Results Showing Gazyva Potential in Primary Membranous Nephropathy

Roche Reports Positive Phase III MAJESTY Results Showing Gazyva Potential in Primary Membranous Nephropathy

(IN BRIEF) Roche reported that its phase III MAJESTY trial met its primary endpoint, showing that treatment with Gazyva/Gazyvaro enabled significantly more patients with primary membranous nephropathy to achieve complete remission at two years compared with tacrolimus. The study also demonstrated meaningful improvements in secondary remission outcomes and confirmed a safety profile consistent with previous research. Because a substantial proportion of patients with this chronic autoimmune kidney disease progress to kidney failure over time, achieving remission is key to preserving renal function and preventing severe complications. The results will be shared with regulators and presented at a forthcoming medical meeting, with the therapy potentially becoming the first approved treatment specifically targeting this condition.

(PRESS RELEASE) BASEL, 16-Feb-2026 — /EuropaWire/ — Roche has announced positive results from the phase III MAJESTY study evaluating Gazyva/Gazyvaro (obinutuzumab) in adults with primary membranous nephropathy, a rare autoimmune kidney disease with limited treatment options. The global trial met its primary endpoint, demonstrating that significantly more patients achieved complete remission at two years compared with those treated with tacrolimus, while maintaining a safety profile consistent with previous studies and identifying no new safety concerns.

Primary membranous nephropathy is a chronic condition in which immune-mediated damage to the kidney’s filtering structures leads to protein loss in the urine and gradual decline in kidney function. Despite current therapies, up to 30 percent of affected individuals may progress to kidney failure within a decade, often requiring dialysis or transplantation. Achieving complete remission is considered a critical clinical goal to preserve renal function and reduce long-term complications.

The MAJESTY study enrolled 142 participants in a randomized, open-label, multicentre design, comparing treatment with Gazyva/Gazyvaro against tacrolimus. In addition to meeting the primary endpoint at week 104, analyses of key secondary endpoints showed statistically significant improvements in overall remission rates and earlier complete remission at week 76 for patients receiving the antibody therapy.

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a humanised 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.

Gazyva/Gazyvaro is approved for adults with lupus nephritis in the US and EU. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

About the MAJESTY study
MAJESTY [NCT04629248] is a phase III, randomised, 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 randomised 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).

About primary membranous nephropathy
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.

About Roche in kidney and kidney-related diseases
For more than 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Today, our industry-leading programme includes Gazyva®/Gazyvaro® (obinutuzumab), approved in the US and EU for adults with active lupus nephritis, and more than 10 phase II-III clinical studies in immune-mediated kidney and kidney-related diseases with some of the highest unmet needs.

Our aim is to continue delivering meaningful value for those affected, healthcare systems and society, and help address this growing public health burden.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

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References
[1] Keri KC, et al.  Primary membranous nephropathy: comprehensive review and historical perspective. Postgrad Med L. 2019 Jan;95(1119). doi: 10.1136/postgradmedj-2018-135729.
[2] Kanigicherla DAK, et al. Long-term outcomes of persistent disease and relapse in primary membranous nephropathy. Nephrol Dial Transplant. 2016 Dec:31(12):2108-2114. doi: 10.1093/ndt/gfv435. Epub 2016 Jan 13.
[3] Furie RA, et al. B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2022 Jan;81(1):100-07.
[4] Furie RA, et al. Efficacy and safety of obinutuzumab in active lupus nephritis. N Engl J Med. 2025 Feb;392:1471-83.

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SOURCE: Roche