Roche's Gazyva Expands into Lupus Nephritis, Shows Promise in Idiopathic Nephrotic Syndrome

Roche's CD20-targeting antibody Gazyva (obinutuzumab) has secured a significant expansion beyond its original oncology indications, marking a new chapter in the treatment of immune-mediated kidney conditions. The drug, initially approved in 2013 for chronic lymphocytic leukemia, has now received FDA clearance for lupus nephritis and demonstrated positive results in a phase 3 trial for idiopathic nephrotic syndrome.

FDA Approval for Lupus Nephritis

The U.S. Food and Drug Administration (FDA) has approved Gazyva for the treatment of adults with active lupus nephritis who are taking standard therapy. This approval is based on results from Roche's late-stage Regency study and phase 2 Nobility trial. In the Regency study, 46% of patients receiving Gazyva with standard therapy achieved complete renal response, compared to 33.1% on standard care alone.

Levi Garraway, M.D., Ph.D., Roche's chief medical officer and head of global product development, stated, "The approval of Gazyva by the FDA marks an important step towards a potential new standard of care for lupus nephritis, one that could allow clinicians to offer their patients more effective disease control."

Lupus nephritis, affecting approximately 1.7 million people worldwide, is a potentially fatal manifestation of systemic lupus erythematosus (SLE) that can lead to irreversible kidney damage. The condition disproportionately affects women, particularly women of color and those of childbearing age.

Promising Results in Idiopathic Nephrotic Syndrome

In addition to its lupus nephritis approval, Gazyva has shown positive results in a phase 3 trial for idiopathic nephrotic syndrome (INS), a rare kidney condition affecting children and young adults. The INShore trial, which enrolled 85 participants aged 2 to 25 years, demonstrated that Gazyva was superior to the immunosuppressant mycophenolate mofetil (MMF) in achieving sustained remission after one year.

Key findings from the INShore trial include:

• Statistically significant and clinically meaningful improvements in complete INS remission
• Better performance in relapse-free survival and median time to relapse or death
• Reduction in cumulative corticosteroid dosing from baseline to one year
• Fewer relapses from baseline to Week 52

Dr. Garraway commented on the INS results, saying, "These results show that Gazyva may achieve robust disease control with a reduced need for corticosteroids, which are associated with serious side effects over time."

Expanding Beyond Oncology

Gazyva's move into lupus nephritis and potential in INS represents a significant expansion beyond its original oncology indications. The drug has been a strong performer for Roche, with 2024 sales reaching 910 million Swiss francs (approximately $1.15 billion), a 16% growth from the previous year.

With the new lupus nephritis indication, analysts at GlobalData predict Gazyva could reach sales of $1.7 billion by 2030. The drug's success in these new areas could potentially lead to further exploration of its use in other immune-mediated kidney conditions.

As Roche continues to investigate Gazyva's potential in various kidney-related autoimmune diseases, including membranous nephropathy and SLE, the pharmaceutical landscape for these conditions may see significant changes in the coming years.