Roche releases positive phase III results for Gazyva/Gazyvaro that demonstrates superiority to standard therapy alone in people with lupus nephritis

Roche releases their new published positive topline results from the phase III REGENCY study of Gazyva/Gazyvaro  in people with active lupus nephritis. In the study, a higher proportion of people treated with Gazyva/Gazyvaro plus standard therapy achieved a complete renal response at 76 weeks compared to those treated with standard therapy alone. Safety was in line with the well-characterised profile of Gazyva/Gazyvaro. No new safety signals were identified.

“Gazyva/Gazyvaro achieved a robust complete renal response rate in lupus nephritis, which is associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease.”

“I am very excited about today’s announcement that the phase III REGENCY study has met its primary endpoint,” said Dr. Brad H. Rovin, Director of Nephrology and Medical Director of the Center for Clinical Research Management at The Ohio State University Wexner Medical Center, and investigator for the REGENCY study. “The results of REGENCY are compelling. Obinutuzumab could offer the lupus community an effective new treatment option for controlling this difficult disease that can be associated with high morbidity for individuals living with lupus.”

The two key secondary endpoints demonstrated statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro – the endpoint proportion of patients achieving CRR with a successful reduction of corticosteroid use, and an improvement in proteinuric response. The endpoints are important indicators for achieving better disease control in lupus nephritis. Other secondary endpoints were not statistically significant, but numerically greater responses were observed for Gazyva/Gazyvaro in several endpoints.

Furthermore, the data is being shared with health authorities, including the US Food and Drug Administration and the European Medicines Agency, to make this potential new treatment option for lupus nephritis available as soon as possible. Data are also being submitted for publication in a medical journal and presentation at a future medical congress.

Note that; Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women and mostly of colour and childbearing age. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys. Despite current treatment options, up to a third of people will develop end-stage kidney disease within 10 years, where dialysis or transplant are the only available options and the risk of mortality is high. Data suggest that Gazyva/Gazyvaro depletes disease-causing B cells, helping to limit further damage to the kidneys and potentially preventing or delaying progression to end-stage kidney disease.

Gazyva/Gazyvaro® was granted Breakthrough Therapy Designation by the US FDA in 2019, based on data from the phase II NOBILITY study. Breakthrough Therapy Designation is designed to accelerate the development and regulatory review of medicines intended to treat serious or life-threatening conditions where preliminary clinical evidence has indicated they may demonstrate substantial improvement over existing therapies.

 

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Related Topics and Keywords

lupus nephritis, phase 3 results, Phase 3 trial, Roche, roche pharma