Roche announced positive topline results from the Phase III REGENCY study, which evaluated Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis. The study met its primary endpoint, demonstrating that a higher proportion of patients treated with Gazyva/Gazyvaro plus standard therapy achieved a complete renal response (CRR) at 76 weeks, compared to those receiving standard therapy alone. These results highlight the potential of Gazyva/Gazyvaro to provide a new treatment option for people living with lupus nephritis, a life-threatening complication of systemic lupus erythematosus.

Safety data was consistent with the known profile of Gazyva/Gazyvaro, with no new safety signals identified.

A Step Forward for Lupus Nephritis Treatment
“Gazyva/Gazyvaro achieved a robust complete renal response rate in lupus nephritis, which is associated with long-term preservation of kidney function and a reduced risk of progression to end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Given that dialysis or transplantation are often required for patients with advanced kidney disease, these findings could represent a significant advancement for people facing this devastating disease.”

Dr. Brad H. Rovin, Director of Nephrology at The Ohio State University Wexner Medical Center and investigator for the REGENCY study, echoed this sentiment: “The results of REGENCY are compelling, and obinutuzumab could offer the lupus community an effective new option to control this challenging disease.”

Key Findings from the REGENCY Study
In addition to meeting its primary endpoint, the REGENCY study demonstrated significant and clinically meaningful improvements in key secondary endpoints:

• Corticosteroid Reduction: Patients achieved CRR alongside a successful reduction in corticosteroid use, an important goal for long-term disease management.
• Proteinuric Response: Improvement in proteinuric response, another key marker for disease control in lupus nephritis, was also statistically significant.

These results will be shared with regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to expedite the availability of Gazyva/Gazyvaro as a new treatment for lupus nephritis. Data will also be submitted for publication and presentation at upcoming medical congresses.

The Global Burden of Lupus Nephritis
Lupus nephritis is a potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting approximately 1.7 million people globally, primarily women of childbearing age. Up to one-third of patients with lupus nephritis may progress to end-stage kidney disease within 10 years, where the only treatment options are dialysis or kidney transplantation. The condition is also associated with a higher mortality risk.

Gazyva/Gazyvaro works by depleting disease-causing B cells, which play a central role in the chronic inflammation that damages the kidneys in lupus nephritis. By targeting these cells, Gazyva/Gazyvaro could prevent or delay progression to end-stage kidney disease, offering hope to those at risk.