10.02.2025.

A new study published in the New England Journal of Medicine confirms that Roche’s Gazyva/Gazyvaro (obinutuzumab) is more effective than standard therapy in treating people with active lupus nephritis (LN).

The phase III REGENCY trial showed that nearly half (46.4%) of patients treated with Gazyva/Gazyvaro plus standard therapy achieved complete renal response (CRR) after 76 weeks, compared to 33.1% of those receiving standard treatment alone.

This marks a significant improvement in managing the disease.

Key findings

• Gazyva/Gazyvaro improved kidney function significantly more than standard treatment alone.
• The benefits were observed across different patient subgroups, suggesting it could help a wide range of lupus nephritis patients.
• Patients receiving Gazyva/Gazyvaro also showed reduced disease activity markers and were able to lower their corticosteroid use.
• The treatment’s safety profile was consistent with previous studies.

Addressing a critical need

Despite available treatments, up to one-third of patients develop end-stage kidney disease within 10 years, requiring dialysis or a transplant.

Dr. Levi Garraway, Roche’s Chief Medical Officer, emphasized the importance of this breakthrough, stating that Gazyva/Gazyvaro offers superior disease control compared to standard treatment.

Dr. Richard Furie, a leading rheumatology expert, also highlighted that the drug allows patients to achieve better results while reducing their reliance on corticosteroids.

Future Research

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate CRR benefits in a phase III lupus nephritis study. It has already received Breakthrough Therapy Designation from the U.S. FDA.

Further studies are underway to explore its benefits in children and adolescents with lupus nephritis, as well as other kidney-related conditions linked to lupus.

For more information, please visit www.roche.com