UPDATE: Positive Phase III Clinical Trial Results Announced for Gazyva for the Treatment of Lupus Nephritis

Genentech announced positive results from the Phase III study (REGENCY) of Gazyva (Obinutuzumab) for people with active lupus nephritis (LN). Gazyva is an engineered humanized monoclonal antibody designed to attack CD20, a protein found on certain types of B cells that cause inflammation and damage to the kidneys. Gazyva works to deplete disease-causing B cells to protect the kidney from further damage and potentially prevent or delay progression to end-stage renal disease.  

Dr. Brad Rovin, a member of the Lupus Foundation of America's Medical Scientific Advisory Council, nephrologist, and one of the investigators on the REGENCY study, stated: "Phase 3 trials are essential for the approval of new therapeutics by regulatory agencies such as the Food and Drug Administration. The REGENCY study is the first phase 3 trial of an anti-CD20 B cell depleting drug to have a positive read-out. Bringing obinutuzumab forward for approval could increase the access of people living with lupus to an effective therapy that targets a key step in disease development."

The REGENCY study was a randomized, double-blind, placebo-controlled study that examined the efficacy and safety of Gazyva plus standard therapy of mycophenolate mofetil and glucocorticoids in 271 people with LN. The study met its primary endpoint and found a higher percentage of individuals receiving Gazyva along standard therapy achieved complete renal response at 76 weeks as evidenced by preserved estimated glomerular filtration rate (eGFR) and reduced kidney flare, compared to those who were treated with the placebo and standard therapy. 

In addition to the REGENCY study, Gazyva is being studied in children and adolescents with LN, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE). Gazyva was granted Breakthrough Therapy designation by the FDA in 2019. Current data of Gazyva is being shared with health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency with the goal of making this treatment available soon. 

To learn more about this and other treatments on the horizon, watch this video. Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. 

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