Roche Reports Positive Phase 3 Results for Gazyva in Rare Kidney Disease

Rare Daily Staff

Roche reported that its drug Gazyva met the main goal of a global phase 3 trial in adults with primary membranous nephropathy, a rare autoimmune disease that can lead to kidney failure.

The MAJESTY study showed that significantly more participants treated with Gazyva achieved complete remission at two years compared with those receiving tacrolimus, the company said. No new safety issues were identified, and the treatment’s safety profile was consistent with previous studies.

Primary membranous nephropathy affects an estimated 96,000 people in the United States and nearly 88,000 in the European Union. Despite available treatments, up to 30 percent of patients progress to kidney failure within a decade, often requiring dialysis or transplant.

Gazyva, also known as Gazyvaro, is a humanized monoclonal antibody that is engineered to target CD20 on B cells. It is approved for adults with lupus nephritis in the United States and European Union. It is also approved in 100 countries for various types of hematological cancers.

If approved for primary membranous nephropathy, Gazyva could become the first therapy specifically indicated for the condition. The drug, a glycoengineered anti-CD20 monoclonal antibody, is designed to deplete B cells implicated in autoimmune activity.

“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,” said Levi Garraway, Roche’s chief medical officer and head of global product development.

Photo: Levi Garraway, Roche’s chief medical officer and head of global product development