Roche's pMN Therapy Meets Primary Endpoint in Phase III Trial
The company has revealed that its humanized, glycoengineered Type II anti-CD20 mAb has achieved superior complete remission rates versus tacrolimus in the MAJESTY study.
Roche has unveiled positive Phase III data for obinutuzumab (Gazyva/Gazyvaro) as a treatment option for adults with autoimmune kidney disease, primary membranous nephropathy (pMN). The MAJESTY study met its primary endpoint, demonstrating a significantly higher rate of complete remission at two years in treated patients — as compared to those treated with tacrolimus — and could position the drug as the first targeted therapy approved specifically for pMN (1).
Obinutuzumab is a humanized, glycoengineered Type II anti‑CD20 monoclonal antibody that depletes B cells by inducing direct cell death and enhancing antibody‑dependent cellular cytotoxicity and phagocytosis. [The therapy] is approved for adults with lupus nephritis in the U.S. and EU, and for multiple B‑cell hematological cancers in about 100 countries worldwide (2,3).
In the randomized, head-to-head MAJESTY trial, adults with biopsy-confirmed pMN received either subcutaneous obinutuzumab or tacrolimus. At week 104, obinutuzumab achieved superior complete remission rates alongside robust overall remission (complete or partial). Secondary endpoints reinforced these findings, including higher complete remission at week 76 and durable responses without reliance on broad immunosuppressants, while the safety profile mirrored prior data for the drug, showing no new signals.
“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, in a company press release (1). “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 affects roughly 88,000 people in the EU and 96,000 in the U.S., often progressing silently to end-stage kidney failure in up to 30% of cases within a decade. Current immunosuppressive regimens, such as tacrolimus, offer partial relief but fall short on sustained complete remission, leaving patients vulnerable to chronic complications such as proteinuria and declining renal function. Roche's investigational use of obinutuzumab builds upon its established role in hematological malignancies and emerging indications in immune-mediated diseases.
Roche anticipates presenting the full MAJESTY dataset at an upcoming medical congress, with regulatory filings to follow for FDA and EMA review. If approved, obinutuzumab could redefine pMN care, offering a precision alternative amid rising interest in B-cell therapies for glomerular diseases. This fourth positive phase III readout for obinutuzumab in kidney immunology further cements Roche's leadership in autoimmune nephrology and could positively impact thousands facing progression to dialysis or transplant.
References
Roche. Roche Announces Positive Phase III Results for Gazyva/ Gazyvaro in Primary Membranous Nephropathy, Marking a Significant Milestone in this Autoimmune Disease. Press Release, Feb. 16, 2026.
Roche. European Commission Approves Roche’s Gazyva/ Gazyvaro for Adults with Active Lupus Nephritis. Press Release, Dec. 9, 2025.
NCI. Obinutuzumab (GAZYVA). dctd.cancer.gov, accessed Feb. 18, 2026.