Positive phase III data for Roche’s Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus

The Phase III ALLEGORY study of Gazyva/Gazyvaro has demonstrated positive results in adults with systemic lupus erythematosus (SLE). The study met its primary endpoint, showing a significant improvement in disease control at one year compared to standard therapy. All key secondary endpoints were also achieved, indicating broad efficacy. Gazyva/Gazyvaro, an anti-CD20 monoclonal antibody, targets B cells, a key driver of SLE inflammation. These results suggest Gazyva/Gazyvaro has the potential to become a new standard of care for the millions affected by SLE worldwide. If approved for SLE, it would be the first anti-CD20 therapy to directly target B cells for this condition. This positive data follows recent approvals for Gazyva/Gazyvaro in lupus nephritis and successful results in idiopathic nephrotic syndrome. No new safety concerns were identified, aligning with the drug's known safety profile. Roche plans to share these findings with global health authorities to expedite potential availability. The ALLEGORY study's success adds to a growing body of evidence supporting Gazyva/Gazyvaro's role in treating immune-mediated diseases.