Roche(US:RHHBY) Globenewswire·2026-02-16 06:00Core Insights - Roche announced that the phase III MAJESTY study for Gazyva®/Gazyvaro® (obinutuzumab) in adults with primary membranous nephropathy met its primary endpoint, demonstrating statistically significant results in achieving complete remission at two years compared to tacrolimus [1][2] Group 1: Study Results - The MAJESTY study showed that significantly more patients achieved complete remission at 104 weeks with Gazyva/Gazyvaro compared to tacrolimus [1] - Key secondary endpoints also indicated statistically significant benefits in overall remission (complete or partial) at week 104 and complete remission at week 76 [2] Group 2: Disease Context - Primary membranous nephropathy is a chronic autoimmune condition affecting nearly 88,000 people in the EU and over 96,000 in the US, with up to 30% of patients developing kidney failure within 10 years [4][10] - The condition leads to significant health system costs and impacts on patients and families due to the need for invasive interventions like dialysis or transplant [4] Group 3: Treatment Implications - If approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for primary membranous nephropathy, addressing a significant unmet need in treatment options [2][4] - The drug has shown potential in maintaining kidney function longer and preventing life-threatening complications associated with the disease [2][4] Group 4: Company Pipeline and Strategy - Gazyva/Gazyvaro is already approved for treating adults with active lupus nephritis and is being investigated in a global phase II study for children and adolescents with lupus nephritis [6] - Roche has a broad pipeline aimed at addressing immune-mediated and kidney-related diseases, with over 10 phase II-III clinical studies ongoing [11]