Roche Reports Successful Late-Stage Results for Gazyva in Lupus Nephritis

Roche’s Gazyva/Gazyvaro (obinutuzumab) has shown promising results in treating patients with active lupus nephritis (LN), outperforming the standard therapy alone. Recent findings from a phase 3 clinical trial, known as REGENCY, have been published in the New England Journal of Medicine. The study evaluates the safety and efficacy of Gazyva/Gazyvaro in combination with standard treatment, which includes mycophenolate mofetil and glucocorticoids, compared to a placebo with the same standard therapy. This research specifically targets those suffering from active or chronic proliferative class 3 or 4 LN, with or without class 5 involvement.

Lupus nephritis, a severe consequence of systemic lupus erythematosus, affects approximately 1.7 million individuals globally. This autoimmune disorder is primarily known for its impact on the kidneys. Currently, there is no definitive cure for LN, which predominantly affects women. Within a decade of diagnosis, up to 33% of LN patients progress to end-stage kidney disease, where dialysis or transplant become the only viable treatments.

Gazyva/Gazyvaro, already approved in 100 countries for treating various types of lymphoma, is an anti-CD20 monoclonal antibody. Administered intravenously, it works by targeting and depleting B cells responsible for the persistent inflammation seen in LN. The trial revealed that 46.4% of patients receiving Gazyva/Gazyvaro alongside standard therapy achieved the study's main goal of complete renal response (CRR) at 76 weeks. In contrast, only 33.1% of those on standard therapy alone reached CRR. This advantage was consistent across different patient subgroups.

Additionally, Gazyva/Gazyvaro was associated with significant improvements in complement levels and reductions in anti-dsDNA, both indicators of disease activity and inflammation. The safety profile of Gazyva/Gazyvaro in this trial aligns with its established safety record in its other approved uses in hematology-oncology.

The findings from the REGENCY trial are currently being reviewed by global health authorities, including in the United States and Europe. This process is part of a partnership between Roche’s Genentech division and Biogen. Roche’s chief medical officer, Levi Garraway, highlighted the importance of these results, noting that nearly half of the LN patients in the study reached a CRR. He emphasized the consistent, clinically meaningful benefits observed across various subgroups, underscoring the superior disease control achieved with Gazyva/Gazyvaro compared to standard treatment alone.

Garraway also pointed out the disproportionate impact of LN on younger women, particularly women of color, which often leads to end-stage kidney disease. The goal of this research is to meet the urgent need for more effective treatment options for this demographic. By offering an alternative that provides better disease management, Roche aims to improve the prognosis for those affected by this challenging condition.