Roche (RHHBY) announced that the phase III REGENCY study of Gazyva/Gazyvaro (obinutuzumab) in patients with active lupus nephritis has yielded positive topline results.
The study found that a greater percentage of individuals receiving Gazyva/Gazyvaro alongside standard therapy (mycophenolate mofetil and glucocorticoids) achieved a complete renal response (CRR) at 76 weeks compared to those on standard therapy alone. The safety profile remained consistent with previous data on Gazyva/Gazyvaro, with no new safety concerns identified.
The study met its primary endpoint, demonstrating statistically significant and clinically meaningful treatment benefits in people with active lupus nephritis.
According to the companies, two key secondary endpoints showed statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro - the endpoint proportion of patients achieving CRR with a successful reduction of corticosteroid use, and an improvement in proteinuric response (both at 76 weeks). The endpoints are important indicators for achieving better disease control in lupus nephritis. Other secondary endpoints were not statistically significant, but numerically greater responses were observed for Gazyva/Gazyvaro in several endpoints.
Lupus nephritis is a potentially life-threatening manifestation of an autoimmune disease that affects approximately 1.7 million people worldwide, predominantly women and mostly of colour and childbearing age.
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