Lupus Nephritis Treatment Shows Positive Results in Phase 3 Trial
Genentech said it’s sharing the data with global health authorities to make the therapy available to patients as soon as possible.
Positive results have been announced from a phase 3 trial evaluating the efficacy and safety of obinutuzumab (Gazyva) plus standard therapy for the treatment of lupus nephritis, Genentech announced in a release.1 The company said it is submitting the data for publication and intends to present it at a future conference.
Lupus Nephritis Treatment Shows Positive Results in Phase 3 Trial / benschonewille - stock.adobe.com
Data from the REGENCY study (NCT04221477) showed obinutuzumab met its primary endpoint of percentage of participants with complete renal response. The therapy also met 2 key secondary endpoints: proportion of patients achieving complete renal response with a successful reduction of corticosteroid use, and an improvement in proteinuric response.
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“I am very excited about today’s announcement that the phase III REGENCY study has met its primary endpoint,” Brad H. Rovin, director of Nephrology and medical director of the Center for Clinical Research Management at The Ohio State University Wexner Medical Center, said in a release.1 “The results of REGENCY are compelling. Obinutuzumab could offer the lupus community an effective new treatment option for controlling this difficult disease that can be associated with high morbidity for individuals living with lupus.”
Obinutuzumab is a type II engineered humanized monoclonal antibody that’s designed to attach to the CD20 protein found on certain B cells, which drives persistent inflammation that damages the kidneys in lupus nephritis. It was previously granted Breakthrough Therapy Designation by the FDA based on results from the phase 2 NOBILITY study (NCT02550652).
REGENCY is a randomized, double-blind, placebo-controlled, multicenter phase 3 study evaluating the efficacy and safety of obinutuzumab plus standard therapy for the treatment of active or chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative class 3 or 4 lupus nephritis, with or without class 5. The study cohort included 271 patients who randomly received either biannual intravenous dosing of obinutuzumab plus standard therapy or placebo plus standard therapy.
Results from the study showed that a higher proportion of patients who received obinutuzumab plus standard therapy achieved complete renal response at 76 weeks compared to the placebo group. A higher proportion of patients who received the therapy also achieved complete renal response with a reduction of corticosteroid use and an improved proteinuric response at 76 weeks compared to placebo. There were no new safety signals associated with obinutuzumab identified during the study.
Genentech said in the release that it’s sharing the data with global health authorities—including the FDA and European Medicines Agency—to make the therapy available to patients as soon as possible. Obinutuzumab is currently approved in the US to treat chronic lymphocytic leukemia with chlorambucil, to treat follicular lymphoma with bendamustine and to treat stage 2 bulky, 3, or 4 follicular lymphoma with chemotherapy.
“Gazyva achieved a robust complete renal response rate in lupus nephritis, which is associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a release.1 “Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease.”
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References
1. Positive Phase III Results for Genentech’s Gazyva Show Superiority to Standard Therapy Alone in People With Lupus Nephritis. News Release. Genentech. September 26, 2024. Accessed September 26, 2024. https://www.businesswire.com/news/home/20240925225486/en/Positive-Phase-III-Results-for-Genentech%E2%80%99s-Gazyva-Show-Superiority-to-Standard-Therapy-Alone-in-People-With-Lupus-Nephritis
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