New York, NY, September 25, 2024 — The Lupus Research Alliance (LRA) and clinical research affiliate Lupus Therapeutics (LT) are excited to share positive news of the Phase 3 REGENCY clinical trial showing benefits of Gazyva® (obinutuzumab) in treating people with active lupus nephritis (inflammation of the kidney associated with lupus). In development as a potential treatment for lupus nephritis, Gazyva is approved in 100 countries for various forms of lymphoma.
The primary endpoint of the Phase 3 REGENCY trial was met, meaning that complete renal response was seen in a higher proportion of people treated with Gazyva plus standard therapy (mycophenolate mofetil and glucocorticoids) at 76 weeks than those given standard therapy alone.
Two secondary endpoints of the study were also achieved, showing statistically significant and clinically meaningful benefits with Gazyva: the proportion of patients achieving complete response rate while also being able to reduce use of corticosteroids was higher among those receiving Gazyva, as well as a lower level of protein in the urine in the treatment group. The safety profile was consistent with what has been reported from the use of Gazyva as approved for other indications.
“Achieving a complete response during the treatment of lupus nephritis is a critical milestone for afflicted individuals. Complete response is associated with excellent maintenance of long-term kidney function. Keeping individuals with lupus nephritis away from every needing dialysis or a kidney transplant is the key goal of lupus nephritis treatment,” commented Brad Rovin, MD, Director, Division of Nephrology and Vice Chair of Research at The Ohio University Wexner Medical Center and a member of the Lupus Clinical Investigators Network overseen by Lupus Therapeutics.
Putting the implications of the study in perspective, Dr. Rovin added, “This is the first positive phase 3 trial of an obinutuzumab in lupus nephritis. These results are really important because B cells are critical for the generation of the autoantibodies characteristic of lupus. We have long-awaited such a therapeutic that could be approved for clinical use. While all the data of Regency will need to be carefully evaluated as obinutuzumab is considered for approval, I am optimistic. REGENCY was a well-designed, well-conducted clinical trial that the entire lupus community can be proud of.”
“This is an exciting time for people with lupus”. commented Albert T. Roy, President and CEO of the LRA. “The REGENCY trial data indicate the compelling potential for Gazyva to treat lupus nephritis, one of the most common and dangerous manifestations of lupus. We look forward to seeing more detailed data when published to the medical community, but the prospects for another new therapy to treat lupus nephritis would be very beneficial.”
Study sponsor Genentech, a member of the Roche group, announced plans to submit the REGENCY data to the U.S. Food and Drug Administration and the European Medicine Agency among other health authorities for consideration in evaluating Gazyva for approval as a treatment for lupus nephritis.
Source: Genentech Sept. 25 Press Release
