Genentech's Gazyva: A Breakthrough in Lupus Nephritis Treatment

Genentech, a member of the Roche Group, has announced positive topline results from the Phase III REGENCY study of Gazyva® (obinutuzumab) in people with active lupus nephritis. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis. Gazyva, when combined with standard therapy (mycophenolate mofetil and glucocorticoids), achieved a higher proportion of complete renal response (CRR) at 76 weeks compared to standard therapy alone. Safety was in line with the well-characterized profile of Gazyva, with no new safety signals identified.

Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women and mostly women of color 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 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 was granted Breakthrough Therapy Designation by the FDA in 2019, based on data from the Phase II NOBILITY study. This 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.

In addition to REGENCY, Gazyva is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis. Our pipeline also includes RG6299 (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, PiaSky® (crovalimab), a novel recycling monoclonal antibody being investigated in atypical hemolytic uremic syndrome, and RG6382, a CD19xCD3 T-cell engaging bispecific antibody.


The positive Phase III results for Gazyva in lupus nephritis represent a significant advancement in the treatment of this devastating disease. With the potential to delay or prevent end-stage kidney disease, Gazyva could offer a much-needed option for people living with lupus nephritis. As data are shared with health authorities and submitted for publication in a medical journal, the hope is that this potential new treatment option will become available as soon as possible.