Roche has released preliminary results from its phase 3 Majesty study evaluating Gazyva (obinutuzumab) in adults with primary membranous nephropathy, reporting that the antibody met its primary endpoint. According to the company a significantly higher proportion of patients treated with Gazyva achieved complete remission at two years compared with those receiving the immunosuppressant tacrolimus.
The study’s main goal was to assess complete remission at the two-year mark. Roche stated that the trial achieved this objective. Additional key secondary endpoints also showed statistically significant and clinically meaningful improvements, including overall remission at Week 104 and complete remission at Week 76.
Roche indicated that the safety findings were consistent with Gazyva’s established profile. The drug has primarily been used in oncology, having first received approval in 2013 for chronic lymphocytic leukemia (CLL). It is also approved for follicular lymphoma.
The company did not provide detailed numerical data in its announcement and said full results will be presented at an upcoming medical meeting. Roche also plans to submit the data to regulatory authorities, including the U.S. Food and Drug Administration and the European Medicines Agency.
“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, M.D., Ph.D., Roche’s chief medical officer and head of global product development.
Primary membranous nephropathy is described by Roche as a chronic autoimmune kidney disease affecting approximately 88,000 people in the European Union and more than 96,000 individuals in the United States. The condition can result in irreversible kidney damage and diminished kidney function. According to the company, up to 30% of diagnosed patients develop kidney failure within 10 years. Those who progress to kidney failure may require dialysis or a kidney transplant.
Currently, there are no treatments specifically approved for primary membranous nephropathy. Physicians often use medications such as ACE inhibitors to manage blood pressure and reduce protein levels in urine. Roche’s Rituxan, another CD20-targeting antibody, is also used off-label in this setting.
Roche has stated that Gazyva works by targeting CD20, a protein expressed on certain B cells, and believes this mechanism may address the underlying cause of the disease. The company said this approach could help preserve kidney function and potentially reduce the risk of severe complications.
Although originally developed for cancer, Gazyva has been studied increasingly in immune-mediated disorders. In October, the drug received FDA approval for use in adults with active lupus nephritis who are already receiving standard therapy. Roche has said that targeting CD20 in lupus nephritis may help protect the kidneys and slow or prevent further disease progression.
Shortly after that approval, the company announced positive phase 3 results for Gazyva in systemic lupus erythematosus. During the same period, Roche also reported late-stage trial success in idiopathic nephrotic syndrome. In that study, Gazyva was found to help more children and young adults achieve sustained remission after one year compared with the immunosuppressant mycophenolate mofetil. Roche has stated it intends to submit those findings to regulators as well.
Gazyva Shows Positive Phase 3 Majesty Results
Gazyva, Roche’s obinutuzumab antibody, achieved success in the Phase 3 Majesty study in adults with primary membranous nephropathy, meeting its primary endpoint and demonstrating significant clinical benefit compared with tacrolimus. The results mark a pivotal milestone for Gazyva in this chronic kidney disease with limited treatment options.
Clinical Outcomes in Majesty Study
In the Majesty trial, patients treated with Gazyva experienced significantly higher rates of complete remission at two years (104 weeks) compared with those on tacrolimus, with no new safety issues identified. Safety outcomes remained consistent with Gazyva’s established profile, supporting its tolerability in this patient population.
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