In a major development, Roche, the Swiss drug giant, has shared positive results from its phase III REGENCY study on obinutuzumab, also known as Gazyva or Gazyvaro, for treating active lupus nephritis (LN). 

The results of trial published in the New England Journal of Medicine showed a meaningful increase in the main goal of complete renal response (CRR). At 76 weeks, 46.4% of patients treated with Gazyva/Gazyvaro plus conventional treatment (mycophenolate mofetil and glucocorticoids) attained CRR, compared to 33.1% of those treated with only standard therapy. 

The REGENCY trial also found clinically significant improvements in complement levels as well as decreases in anti-dsDNA, disease activity indicators, and inflammation. These findings were reported at the World Congress of Nephrology (WCN) 2025 and have been shared with health authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency.

Roche's chief medical officer and head of global product development, Dr Levi Garraway, emphasised the significance of the findings saying "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." 
"Lupus nephritis disproportionately affects younger women, particularly those of colour, and frequently leads to end-stage kidney disease," he went on to say. 
"Our objective is to meet this pressing need by offering a more effective therapy," Dr Garraway further added. 

Dr. Richard Furie, who is the head of Rheumatology at Northwell Health in the U.S., highlighted the study results by saying, "The good results from the REGENCY study support what we found in a previous trial. Using obinutuzumab, which targets B cells, helps patients with lupus nephritis more than just the standard treatment." He also highlighted that patients who had obinutuzumab were more likely to obtain the intended outcome while also being able to reduce corticosteroids.

The drug'ss safety profile was consistent with the well-established profile seen in its haematology-oncology applications. At week 76, patients taking Gazyva/Gazyvaro along with standard treatment were more likely to reach complete recovery and lower their use of corticosteroids compared to those only on standard treatment. Furthermore, when treated with obinutuzumab in addition to conventional therapy, a greater proportion of patients improved in proteinuria response than when treated with standard therapy alone, the company statement added.

Lupus nephritis is a potentially fatal autoimmune illness that affects around 1.7 million people worldwide, the majority of whom are women of colour and of reproductive age. Despite current treatment choices, up to one-third of persons will acquire end-stage renal disease within ten years, leaving only dialysis or transplant as alternatives with a substantial risk of death.

Obinutuzumab is the only anti-CD20 monoclonal antibody that showed a CRR advantage in a randomised Phase III study in lupus nephritis. Based on findings from the phase II NOBILITY trial, the US FDA designated obinutuzumab as a Breakthrough Therapy in 2019. In addition to REGENCY, obinutuzumab is being studied in children and adolescents with lupus nephritis, membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and systemic lupus erythematosus (SLE).