MAJESTY study shows Gazyva met primary endpoint in membranous nephropathy

Roche announced its Phase 3 MAJESTY trial in adults with primary membranous nephropathy met the primary endpoint, with significantly more people reaching complete remission at two years with Gazyva/Gazyvaro versus tacrolimus; safety was reported as consistent with the known profile and no new safety signals were identified.

Roche announced that its Phase 3 MAJESTY study in adults with primary membranous nephropathy met its primary endpoint. The trial compared Gazyva/Gazyvaro with tacrolimus. The company reported statistically significant and clinically meaningful results for remission outcomes at specified time points. Roche said safety observations were in line with the drug's well‑characterized profile and that no new safety signals were identified. Key findings: - The MAJESTY study met its primary endpoint, with significantly more participants achieving complete remission at two years with Gazyva/Gazyvaro versus tacrolimus. - Key secondary analyses showed statistically significant benefits for overall remission at week 104 and for complete remission at week 76 with Gazyva/Gazyvaro versus tacrolimus. - Safety results were reported as consistent with the known profile of Gazyva/Gazyvaro and no new safety signals were identified. - Roche said the data will be presented at an upcoming medical meeting and shared with health authorities, including the U.S. Food and Drug Administration and the European Medicines Agency. - The company stated that, if approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for people with primary membranous nephropathy, where treatment options are limited. Summary: Roche reported positive Phase 3 outcomes for Gazyva/Gazyvaro in primary membranous nephropathy, showing higher rates of complete remission compared with tacrolimus and no new safety concerns. The company will present the results at a medical meeting and share data with regulators; further regulatory review is the next procedural step.