Roche Advances PMN Treatment With Phase III Success

Global healthcare leader Roche has reported a major breakthrough in primary membranous nephropathy (PMN), a rare autoimmune kidney disease with limited treatment options.

The company announced that its phase III MAJESTY study met its primary endpoint, showing significantly more patients achieved complete remission at two years with Gazyva/Gazyvaro compared to standard treatment with tacrolimus. “This is a landmark moment,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development.

“These results demonstrate that Gazyva/Gazyvaro may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications. If approved, Gazyva/Gazyvaro would be the first therapy specifically indicated for people with primary membranous nephropathy, where there are limited treatment options.”

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Primary membranous nephropathy is a chronic disease that damages the kidneys’ filtering units. It affects nearly 88,000 people across the EU and more than 96,000 in the US. Up to 30% of patients develop kidney failure within 10 years, often requiring dialysis or a transplant.

The MAJESTY trial enrolled 142 adults who were randomly assigned to receive Gazyva/Gazyvaro or tacrolimus. Along with meeting the main goal, the study showed strong results in overall remission at week 104 and complete remission at week 76. Safety findings were consistent with the drug’s known profile, with no new concerns.

Gazyva/Gazyvaro, a glycoengineered anti-CD20 monoclonal antibody, has also shown success in lupus nephritis, systemic lupus erythematosus, and idiopathic nephrotic syndrome. This marks its fourth positive phase III study in immune-mediated diseases.