Roche Trial Offers Hope to Patients with Rare Kidney Disease
•February 16, 2026
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Why It Matters
The trial could deliver the first approved, targeted therapy for pMN, reducing reliance on toxic immunosuppressants and potentially lowering the risk of kidney failure for thousands of patients.
Key Takeaways
- •Gazyva achieved superior two‑year remission versus tacrolimus.
- •Primary membranous nephropathy affects ~184k patients in US/EU.
- •Up to 30% progress to kidney failure within ten years.
- •Safety profile aligns with previous anti‑CD20 data.
- •Roche forecasts $1.8 bn sales by 2030 with expanded indications.
Pulse Analysis
Primary membranous nephropathy remains one of the most challenging autoimmune kidney disorders, accounting for the majority of membranous nephropathy cases. Patients typically rely on broad‑acting immunosuppressants that carry risks of infection, bone‑marrow suppression, and even malignancy, while up to a third still progress to end‑stage renal disease within a decade. The lack of a targeted, disease‑modifying option has left clinicians navigating a narrow therapeutic window, underscoring the urgent need for safer, more effective interventions.
The MAJESTY phase 3 trial positioned Gazyva as a potential breakthrough by directly depleting CD20‑positive B cells that drive the pathogenic antibody response in pMN. Results demonstrated a statistically significant increase in complete remission at the two‑year mark, alongside consistent safety outcomes that mirror the drug’s established oncology and lupus nephritis profiles. Secondary endpoints, including partial remission and durability of response through week 104, also favored Gazyva, suggesting a robust and lasting therapeutic effect that could reshape treatment algorithms for this rare disease.
Beyond clinical impact, Roche’s data opens a sizable commercial opportunity. With an estimated 184,000 patients across the United States and Europe, and projected sales of $1.8 billion by 2030, the drug could become a cornerstone of Roche’s expanding kidney‑disease portfolio. The company’s parallel phase 3 successes in idiopathic nephrotic syndrome and systemic lupus erythematosus further signal a strategic push to dominate the anti‑CD20 space in renal indications. Regulatory submissions slated for the US and EU this year will be closely watched, as approval could set a new standard of care and stimulate additional research into B‑cell targeting for other autoimmune kidney disorders.
Roche trial offers hope to patients with rare kidney disease
A study of Roche's Gazyva has raised the prospect of a first approved therapy for primary membranous nephropathy (pMN), a rare autoimmune kidney disorder.
The phase 3 MAJESTY trial of anti‑CD20 antibody Gazyva (obinutuzumab), known as Gazyvaro in some markets, met its primary endpoint, with significantly more patients achieving disease remission with the drug compared to immunosuppressant tacrolimus, the active control.
In pMN, the immune system launches an attack on the glomeruli structures of the kidney responsible for its blood‑filtering function, leading to a gradual and progressive decline in renal function. It accounts for 70 % to 80 % of all membranous nephropathy cases and affects around 88 000 people in the EU and 96 000 in the US.
Up to 30 % of people with the disease progress to kidney failure over 10 years, despite current treatment approaches based on immune‑suppressing drugs that can also cause significant side effects, such as infections, bone‑marrow suppression, and cancer.
According to top‑line results announced by Roche this morning, significantly more people achieved complete remission at two years with Gazyva versus tacrolimus, with a safety profile that was in line with what has previously been reported with the anti‑CD20 antibody, which achieved a 25 % hike in sales to $1.28 billion last year.
The results – which will be presented at an upcoming medical meeting and submitted to regulators in the US, Europe, and other parts of the world – also showed a significant improvement with Gazyva on secondary endpoints, such as complete or partial remission at week 104 and complete remission at week 76.
“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, Roche's chief medical officer.
Originally developed as a more‑potent follow‑up to Roche's long‑established CD20‑directed antibody Rituxan (rituximab) for blood cancers and launched in 2013, Gazyva is seeing a spike in use thanks to its recent approval for lupus nephritis, a kidney complication of autoimmune disease systemic lupus erythematosus (SLE).
Roche has aspirations to add to the drug's indications in kidney diseases even further, and has also reported positive phase 3 results with the drug in idiopathic nephrotic syndrome and in reducing disease activity more broadly in SLE. GlobalData has predicted that sales of the drug could reach $1.8 billion or more in 2030, fuelled by expanded indications.
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