The New England Journal of Medicine has published detailed findings from Roche’s Phase III REGENCY trial, which demonstrated the superiority of Gazyva®/Gazyvaro® (obinutuzumab) in combination with standard therapy for treating active lupus nephritis (LN). The trial shows a compelling improvement in the complete renal response (CRR) rate, with nearly half of the patients achieving CRR when treated with Gazyva/Gazyvaro, compared to the standard therapy alone.
“The fact that nearly half of lupus nephritis patients achieved a complete renal response, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with Gazyva/Gazyvaro compared to standard treatment alone,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
The trial revealed that 46.4% of patients receiving Gazyva/Gazyvaro with standard therapy achieved CRR at 76 weeks, compared to 33.1% with standard therapy alone (adjusted difference 13.4%, 95% CI, 2.0%-24.8%; P=0.0232). Additionally, the study highlighted improvements in complement levels, reductions in anti-dsDNA, and better markers of disease activity and kidney inflammation among patients treated with Gazyva/Gazyvaro.
These data were presented at the World Congress of Nephrology (WCN) 2025 and are under review by regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency.
“The positive REGENCY study results confirmed the findings of an earlier trial that administration of obinutuzumab, a therapy which targets B cells, benefitted patients with lupus nephritis more than standard treatment alone,” said Dr. Richard Furie, Chief of the Division of Rheumatology at Northwell Health, US.
Key Findings from the REGENCY Trial
The REGENCY trial is the first randomized Phase III study to show a CRR benefit with an anti-CD20 monoclonal antibody in lupus nephritis. Key findings include:
- CRR Benefit with Prednisone Taper: 42.7% of patients in the Gazyva group tapered to ≤7.5 mg/day prednisone, compared to 30.9% in the placebo group.
- Proteinuric Response: A higher proportion of patients (55.5%) achieved significant proteinuric response (UPCR <0.8 g/g) with Gazyva than with standard therapy alone (41.9%).
- Results were consistent across subgroups, including patients with Class III/IV lupus nephritis, Class V disease, and high serologic activity.
The safety profile of Gazyva/Gazyvaro remained consistent with previously observed data in hematology-oncology indications.
Addressing the Unmet Need in Lupus Nephritis
Lupus nephritis (LN) is a severe complication of systemic lupus erythematosus (SLE), an autoimmune disease that predominantly affects women of color during childbearing age. LN impacts approximately 1.7 million people worldwide, often leading to end-stage kidney disease (ESKD) within 10 years if untreated. Current treatment options are limited, highlighting the significant unmet need for effective therapies like Gazyva.
Roche’s Gazyva/Gazyvaro is uniquely designed to deplete disease-causing B cells that drive inflammation and kidney damage in lupus nephritis. It is already approved in 100 countries for various lymphoma indications and has demonstrated a breakthrough in addressing kidney-related autoimmune diseases.
About the REGENCY Study
The REGENCY trial was a randomized, double-blind, placebo-controlled Phase III study involving 271 participants. Patients received either biannual Gazyva/Gazyvaro intravenous infusions alongside standard therapy or placebo with standard therapy. The study found Gazyva/Gazyvaro superior in achieving CRR, with significant corticosteroid reduction and improvement in proteinuric response.
These results reinforce the findings of the earlier Phase II NOBILITY study, which earned Gazyva Breakthrough Therapy Designation from the U.S. FDA in 2019. In addition to lupus nephritis, Gazyva is also under investigation for conditions like membranous nephropathy and systemic lupus erythematosus.
Roche continues its commitment to innovation in kidney diseases, building an extensive pipeline of therapies to tackle autoimmune and kidney-related conditions worldwide.
