Key Takeaways
- Phase III MAJESTY met primary endpoint: higher complete remission at week 104 with Gazyva/Gazyvaro vs. tacrolimus in pMN.
- Statistically significant overall remission (complete/partial) at week 104 and complete remission at week 76.
- Safety consistent with known profile; no new signals.
- Data for upcoming congress and regulators (FDA/EMA); potential first targeted pMN therapy.
Written By: Dr. Pavan Kumar Chikkula, PharmD
Reviewed By: Pharmacally Editorial Team
Roche on 16 February 2026 announced positive topline results from the phase III MAJESTY study, evaluating Gazyva®/Gazyvaro® (obinutuzumab) in adults with primary membranous nephropathy (pMN). The study met its primary endpoint, demonstrating statistically significant and clinically meaningful outcomes, with significantly more patients achieving complete remission at week 104 compared to tacrolimus. Safety aligned with the established profile of Gazyva/Gazyvaro, with no new signals identified.
“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.”
Key secondary endpoints also favored Gazyva/Gazyvaro, showing statistically significant and clinically meaningful improvements in overall remission (complete or partial) at week 104 and complete remission at week 76 versus tacrolimus.
Full data will be presented at an upcoming medical congress and submitted to regulatory authorities, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
MAJESTY Study
The MAJESTY study (NCT04629248) is a first global phase III, randomized, open-label, multicentre trial enrolling 142 adults with pMN. Participants were randomized 1:1 to receive Gazyva/Gazyvaro or tacrolimus, with the primary endpoint defined as the proportion achieving complete remission at week 104.
By targeting CD20 on B cells via its glycoengineered Fc region and Type II mechanism, Gazyva/Gazyvaro induces direct B-cell death and enhanced antibody-dependent cellular cytotoxicity (ADCC), potentially halting the autoimmune attack at its source.
This marks the fourth positive phase III readout for Gazyva/Gazyvaro in immune-mediated diseases, building on successes in REGENCY (lupus nephritis), ALLEGORY (systemic lupus erythematosus), and INShore (idiopathic nephrotic syndrome).
Gazyva/Gazyvaro is already approved in the US and EU for adults with active lupus nephritis based on REGENCY and NOBILITY data and is under study in pediatric lupus nephritis (phase II).
About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a humanized monoclonal antibody with a novel Type II anti-CD20 design for B-cell depletion and a glycoengineered Fc region boosting ADCC. Beyond pMN and lupus nephritis, it is approved in over 100 countries for various hematological malignancies, including follicular lymphoma and chronic lymphocytic leukemia.
These MAJESTY results position Gazyva/Gazyvaro as a frontrunner for pMN, addressing a critical unmet need in autoimmune nephrology.
Understanding Primary Membranous Nephropathy
Primary membranous nephropathy is a rare chronic autoimmune kidney disease affecting nearly 88,000 people in the EU and over 96,000 in the US. It occurs when the immune system attacks the kidney’s glomeruli the filtering units leading to protein leakage into the urine (proteinuria) and progressive decline in kidney function. Up to 30% of patients progress to end-stage kidney disease within 10 years.
Reference
Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease, 16 February 2026, Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants with Primary Membranous Nephropathy (MAJESTY), ClinicalTrials.gov ID NCT04629248, https://clinicaltrials.gov/study/NCT04629248