New England Journal of Medicine publishes new data for Roche’s Gazyva/Gazyvaro which shows superiority over standard therapy in people with active lupus nephritis

Basel, 7 February 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that a detailed analysis of its phase III REGENCY trial of Gazyva®/Gazyvaro® (obinutuzumab) in people with active lupus nephritis (LN) was published in the New England Journal of Medicine.¹ The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of complete renal response (CRR), showing that 46.4% of people treated with Gazyva/Gazyvaro plus standard therapy (mycophenolate mofetil and glucocorticoids) achieved CRR at 76 weeks compared with 33.1% of people treated with standard therapy alone (adjusted difference 13.4%, 95% CI, 2.0%-24.8%; P=0.0232). This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation.¹