Roche (RHHBY) has reported positive topline results from its phase III REGENCY study of Gazyva/Gazyvaro (obinutuzumab) in patients with active lupus nephritis.
The findings indicate that a higher proportion 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. Importantly, the safety profile for Gazyva/Gazyvaro remained consistent with previous studies, and no new safety issues were identified.
The study achieved its primary endpoint, revealing statistically significant and clinically meaningful treatment benefits for individuals with active lupus nephritis.
Moreover, the companies highlighted two key secondary endpoints that demonstrated significant and meaningful benefits with Gazyva/Gazyvaro: the proportion of patients achieving CRR with a reduction in corticosteroid use, and an improvement in proteinuric response (both at 76 weeks). These endpoints are crucial for better disease management in lupus nephritis. While other secondary endpoints were not statistically significant, Gazyva/Gazyvaro showed numerically greater responses in several measures.
Lupus nephritis, a potentially life-threatening manifestation of the autoimmune disease lupus, affects approximately 1.7 million individuals globally, predominantly women, particularly those of color and of childbearing age.
