Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that its phase III MAJESTY study met its primary endpoint in adults with primary membranous nephropathy (PMN), demonstrating statistically significant and clinically meaningful results with Gazyva®/Gazyvaro® (obinutuzumab).
At 104 weeks, significantly more patients treated with Gazyva/Gazyvaro achieved complete remission compared with those receiving tacrolimus. The safety profile was consistent with the medicine’s well-established record, and no new safety signals were identified.
Potential First Approved Therapy for PMN
According to Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, the findings suggest Gazyva/Gazyvaro may help more patients achieve sustained remission, preserve kidney function longer, and delay or prevent life-threatening complications.
If approved, Gazyva/Gazyvaro would become the first therapy specifically indicated for primary membranous nephropathy, a condition currently managed with limited and often non-specific treatment options.
Key Secondary Endpoints Also Met
Beyond the primary endpoint, MAJESTY demonstrated statistically significant and clinically meaningful improvements across several secondary measures, including:
- Overall remission (complete or partial remission) at week 104
- Complete remission at week 76
Full data from the study will be presented at an upcoming medical congress and submitted to global regulators, including the U.S. Food and Drug Administration and the European Medicines Agency.
Understanding Primary Membranous Nephropathy
Primary membranous nephropathy is a chronic autoimmune kidney disease that can lead to progressive and irreversible damage.
- Approximately 88,000 people in the EU and over 96,000 in the US are estimated to be affected.
- Up to 30% of patients may progress to kidney failure within 10 years.
- Advanced disease often requires dialysis or kidney transplantation.
The disease not only imposes a significant clinical burden but also carries high costs for healthcare systems and a substantial impact on patients’ quality of life.
By targeting an underlying cause of the disease, Gazyva/Gazyvaro has the potential to alter the course of PMN rather than simply manage symptoms.
Expanding Evidence in Immune-Mediated Diseases
MAJESTY marks the fourth positive phase III trial for Gazyva/Gazyvaro in immune-mediated conditions, following:
- REGENCY in lupus nephritis
- ALLEGORY in systemic lupus erythematosus
- INShore in idiopathic nephrotic syndrome
Gazyva/Gazyvaro is already approved in the US and EU for adults with active lupus nephritis, supported by data from REGENCY and the NOBILITY trial. It is also being studied in a global phase II program for pediatric lupus nephritis.
Strategic Focus on Immunology and Kidney Disease
The positive MAJESTY results reinforce Roche’s broader strategy to expand its leadership in immunology, particularly across immune-mediated and kidney-related diseases. With a growing pipeline and multiple late-stage programs, Roche is positioning Gazyva/Gazyvaro as a potential foundational therapy across several autoimmune indications.
If regulators grant approval for PMN, the therapy could represent a significant shift in the treatment landscape for a disease where long-term kidney preservation remains a critical unmet need.
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