Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from the Phase III REGENCY study of Gazyva®/Gazyvaro® (obinutuzumab) in patients with active lupus nephritis. The study revealed that a higher percentage of patients treated with Gazyva/Gazyvaro in combination with standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those receiving standard therapy alone. The safety profile of Gazyva/Gazyvaro was consistent with its well-established characteristics, and no new safety concerns were identified.
“Gazyva/Gazyvaro showed a significant complete renal response rate in lupus nephritis, a key factor in preserving long-term kidney function and delaying or preventing end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Given that advanced kidney disease often requires dialysis or transplants, these findings could mark an important step forward for individuals living with this severe condition.”
Dr. Brad H. Rovin, Director of Nephrology at The Ohio State University Wexner Medical Center and an investigator for the REGENCY study, expressed his excitement over the results: “The REGENCY study’s achievement of its primary endpoint is highly encouraging. The results suggest that obinutuzumab could provide the lupus community with a new, effective treatment option for managing this challenging disease, which carries significant morbidity for patients.”
Two secondary endpoints of the study also showed significant and clinically meaningful benefits with Gazyva/Gazyvaro. These included a higher proportion of patients achieving CRR with reduced corticosteroid use and improvements in proteinuric response at 76 weeks. These measures are crucial for improved disease management in lupus nephritis. While other secondary endpoints were not statistically significant, Gazyva/Gazyvaro showed numerically greater responses in several areas.
Roche is currently sharing the data with health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency, to expedite the availability of this potential new treatment for lupus nephritis. The findings are also being submitted for publication in a medical journal and will be presented at an upcoming medical conference.
Lupus nephritis is a serious and potentially life-threatening complication of an autoimmune disease affecting about 1.7 million people globally, mostly women of color and childbearing age. In lupus nephritis, B cells drive chronic inflammation that damages the kidneys. Despite existing treatments, up to one-third of patients will develop end-stage kidney disease within 10 years, where dialysis or transplantation are the only options, and mortality rates are high. Studies suggest that Gazyva/Gazyvaro depletes these harmful B cells, helping to prevent or delay the progression to end-stage kidney disease.
Gazyva/Gazyvaro received Breakthrough Therapy Designation from the FDA in 2019, based on data from the Phase II NOBILITY study. This designation aims to speed up the development and regulatory review of drugs that show significant improvement over existing therapies for serious or life-threatening conditions.
Beyond REGENCY, Gazyva/Gazyvaro is being studied in children and adolescents with lupus nephritis, patients with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE), another autoimmune disease that often leads to lupus nephritis. Roche’s pipeline also includes RG6299 (ASO factor B), an antisense oligonucleotide therapy for people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a bispecific antibody being studied for SLE, PiaSky® (crovalimab), a monoclonal antibody for atypical hemolytic uremic syndrome, and RG6382, a CD19xCD3 bispecific antibody.
