Roche’s Gazyva/Gazyvaro Shows Superiority in Phase III Lupus Nephritis Trial

Roche's Gazyva/Gazyvaro Shows Promising Phase III Results for Lupus Nephritis

Roche has announced successful outcomes from the Phase III REGENCY study examining Gazyva®/Gazyvaro® (obinutuzumab) in patients with active lupus nephritis. This study achieved its primary goal, demonstrating significant and clinically meaningful benefits for those treated with Gazyva/Gazyvaro in addition to standard therapy, compared to standard therapy alone. Specifically, a higher percentage of patients attained a complete renal response (CRR) at 76 weeks when treated with Gazyva/Gazyvaro. The safety profile of Gazyva/Gazyvaro was consistent with previous data, and no new safety concerns emerged.

According to Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, achieving a robust CRR in lupus nephritis is crucial for preserving long-term kidney function and delaying or preventing end-stage kidney disease. This is particularly significant since patients with advanced kidney disease often require dialysis or transplants.

Dr. Brad H. Rovin, Director of Nephrology and Medical Director at The Ohio State University Wexner Medical Center, also expressed enthusiasm, noting that the REGENCY study provides compelling evidence that obinutuzumab could offer a new, effective treatment option for lupus nephritis, a challenging disease with high morbidity.

The study's secondary endpoints further supported the benefits of Gazyva/Gazyvaro. These included a significant reduction in corticosteroid use and an improvement in proteinuric response at 76 weeks, both of which are critical indicators for better disease management in lupus nephritis. Although some secondary endpoints didn't reach statistical significance, they showed numerically better responses for Gazyva/Gazyvaro.

Roche is sharing these findings with health authorities, including the FDA and the European Medicines Agency, aiming to make this treatment option available soon. The data will also be submitted for publication in a medical journal and presented at future medical conferences.

Lupus nephritis, impacting approximately 1.7 million people globally—predominantly women of color and of childbearing age—is a severe manifestation of systemic lupus erythematosus (SLE). It involves disease-causing B cells that perpetuate kidney-damaging inflammation. Despite current treatments, up to a third of lupus nephritis patients progress to end-stage kidney disease within a decade, necessitating dialysis or transplantation and carrying a high risk of mortality. Gazyva/Gazyvaro works by depleting these harmful B cells, potentially preventing further kidney damage and delaying progression to end-stage kidney disease.

Gazyva/Gazyvaro received Breakthrough Therapy Designation from the FDA in 2019, based on promising Phase II results from the NOBILITY study. This designation aims to expedite the development and regulatory review of medicines for serious or life-threatening conditions that show substantial improvement over existing therapies.

Gazyva/Gazyvaro is also being explored in other kidney-related conditions, including membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and SLE. The potential of Gazyva/Gazyvaro extends beyond lupus nephritis, with ongoing investigations in various kidney diseases demonstrating Roche’s commitment to addressing unmet needs in this therapeutic area.

Established in 1896, Roche has grown into a global leader in biotechnology and in-vitro diagnostics. The company remains dedicated to scientific excellence and innovation, aiming to improve lives through personalized healthcare. Roche continues to collaborate with various stakeholders to enhance healthcare delivery and sustainability, committing to achieving net zero by 2045.

For over 125 years, Roche has been at the forefront of developing innovative medicines and diagnostics, aiming to help people lead healthier lives. Genentech, a member of the Roche Group, and Chugai Pharmaceutical in Japan are part of Roche's global healthcare network.