Genentech's Gazyva Outperforms Standard Therapy in Lupus Nephritis Phase III Trial

Genentech, a member of the Roche Group, announced positive topline results from the Phase III REGENCY study of Gazyva® (obinutuzumab) in patients with active lupus nephritis. The study demonstrated that a higher percentage of individuals treated with Gazyva, in addition to standard therapies mycophenolate mofetil and glucocorticoids, achieved a complete renal response (CRR) at 76 weeks compared to those who received only the standard therapy. Safety results were consistent with the known profile of Gazyva, with no new safety concerns identified.

Levi Garraway, M.D., Ph.D., Genentech’s Chief Medical Officer and Head of Global Product Development, highlighted the importance of these findings. He emphasized that achieving a robust CRR in lupus nephritis is linked to long-term kidney function preservation and the potential to delay or prevent end-stage kidney disease, where patients often require dialysis or transplants.

Dr. Brad H. Rovin, Director of Nephrology and Medical Director at The Ohio State University Wexner Medical Center, also expressed enthusiasm about the results. He noted that the REGENCY study's achievement of its primary endpoint is promising and could offer the lupus community a new, effective treatment option for managing this challenging disease.

Aside from the primary endpoint, two key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva. These included the percentage of patients achieving CRR with reduced corticosteroid use and improvement in proteinuric response at 76 weeks. Although other secondary endpoints were not statistically significant, numerical improvements were observed in several areas.

The data from this study are being shared with health authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency, aiming to make this potential new treatment option available to lupus nephritis patients as soon as possible. The data are also being prepared for submission to a medical journal and future medical congress presentations.

Lupus nephritis is a severe manifestation of systemic lupus erythematosus, an autoimmune disease that affects approximately 1.7 million people worldwide, mainly women, particularly those of color and of childbearing age. The condition leads to persistent kidney inflammation caused by B cells, resulting in progressive kidney damage. Despite existing treatments, up to a third of patients progress to end-stage kidney disease within ten years, necessitating dialysis or transplantation.

Gazyva works by depleting disease-causing B cells, aiming to limit kidney damage and prevent or delay progression to end-stage kidney disease. It received Breakthrough Therapy Designation from the FDA in 2019 based on positive data from the Phase II NOBILITY study. This designation accelerates the development and review of drugs targeting serious or life-threatening conditions with potential substantial improvements over existing treatments.

Beyond the REGENCY study, Gazyva is being investigated in various other conditions, including membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE). Genentech's pipeline also features other investigational therapies targeting different immune-mediated kidney diseases.

Genentech, headquartered in South San Francisco, California, has a long-standing commitment to addressing unmet needs in kidney diseases through innovative treatment options. The company's substantial pipeline includes ongoing clinical studies aimed at improving outcomes for patients with various kidney-related conditions.