Key Takeaways
- Gazyva/Gazyvaro significantly improves complete renal response rates in lupus nephritis patients compared to standard therapy alone.
- Secondary endpoints show a successful reduction in corticosteroid use and improved proteinuric response.
- No new safety concerns were identified, maintaining the well-characterized safety profile of Gazyva/Gazyvaro.
- Roche is pursuing regulatory approval to make this therapy available to patients as soon as possible.
Roche has announced promising findings from its phase III REGENCY study involving Gazyva®/Gazyvaro® (obinutuzumab) for treating active lupus nephritis. The results reveal that a higher proportion of patients treated with Gazyva/Gazyvaro alongside standard therapy achieved a complete renal response (CRR) at 76 weeks compared to those receiving standard therapy alone. This breakthrough could signify a major advancement for patients grappling with this severe autoimmune condition.
The REGENCY study met its primary endpoint, showcasing statistically significant and clinically meaningful benefits for patients with active lupus nephritis. Gazyva/Gazyvaro, when added to standard therapy, led to an enhanced CRR rate at 76 weeks, alongside a reduction in corticosteroid use and improved proteinuric response. These secondary endpoints are critical for better disease management and patient outcomes. Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, emphasized the long-term preservation of kidney function associated with Gazyva/Gazyvaro, highlighting its potential to prevent end-stage kidney disease.
Promising New Treatment Option for Lupus Nephritis: Roche Seeks Regulatory Approval for Gazyva/Gazyvaro
Dr. Brad H. Rovin, Director of Nephrology at The Ohio State University Wexner Medical Center, expressed enthusiasm about the results, noting that obinutuzumab might offer a new effective treatment option for lupus nephritis, a condition often marked by high morbidity and mortality. The consistent safety profile of Gazyva/Gazyvaro was also underscored, with no new safety signals identified during the study.
Roche is sharing the data with health authorities, including the U.S. FDA and the European Medicines Agency, aiming for swift regulatory approval. The findings will also be submitted for publication in medical journals and presented at upcoming medical congresses. Roche’s commitment to addressing lupus nephritis extends beyond the REGENCY study, with ongoing investigations into Gazyva/Gazyvaro for various kidney-related conditions and systemic lupus erythematosus (SLE).
REGENCY Study Results Signal Hope for Lupus Nephritis Patients: Gazyva/Gazyvaro Shows Promise in Reducing Kidney Damage
The phase III results from the REGENCY study offer a beacon of hope for patients with active lupus nephritis, a condition that affects approximately 1.7 million people globally, primarily women of color and childbearing age. Despite existing treatments, a significant portion of patients progress to end-stage kidney disease, where dialysis or transplantation become the only viable options. Gazyva/Gazyvaro targets disease-causing B cells, potentially curbing kidney damage and delaying disease progression.
Roche’s dedication to advancing treatments for kidney diseases is evident through their extensive clinical pipeline, which includes several ongoing studies for various renal conditions. This commitment underscores the company’s broader mission to innovate and improve patient outcomes in chronic and life-threatening diseases. As the data from the REGENCY study undergoes rigorous review, the lupus nephritis community can remain hopeful for a new, effective treatment option on the horizon.
Resource: Roche, September 26, 2024
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