Roche’s Gazyva/Gazyvaro (obinutuzumab) has demonstrated superiority over standard therapy in patients with active lupus nephritis (LN), according to new late-stage data published in the New England Journal of Medicine.
The phase 3 REGENCY trial has been comparing the safety and efficacy of Gazyva/Gazyvaro against placebo, both taken alongside standard therapy mycophenolate mofetil and glucocorticoids in patients with active/chronic proliferative class 3 or 4 LN, with or without class 5.
Affecting approximately 1.7 million people worldwide, LN is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys.
There is currently no cure for the LN, which mainly impacts women and causes up to a third of patients to progress to end-stage kidney disease within ten years of diagnosis, at which point the only available treatment options are dialysis or transplant.
Already approved in 100 countries for various types of lymphoma, Gazyva/Gazyvaro is an intravenously-administered anti-CD20 monoclonal antibody designed to deplete disease-causing B cells that drive persistent inflammation in LN.
Results demonstrated that 46.4% of patients randomised to receive Gazyva/Gazyvaro plus standard therapy achieved the study’s primary endpoint of complete renal response (CRR) at week 76, compared to 33.1% of patients receiving standard therapy alone, with this CRR benefit found to be consistent across patient subgroups.
Clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation, were also observed for Gazyva/Gazyvaro, and the drug’s safety profile was consistent with the well-characterised profile observed in its haematology-oncology indications.
Data from REGENCY is now being shared with health authorities worldwide, including in the US, where it is part of a collaboration between Roche’s Genentech unit and Biogen, and in the EU.
Roche’s chief medical officer and head of global product development, Levi Garraway, said: “The fact that nearly half of LN patients achieved a CRR, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with Gazyva/Gazyvaro compared to standard treatment alone.
“LN disproportionately affects younger women, mostly women of colour, often leading to end-stage kidney disease. Our goal is to address this urgent need by providing a more effective treatment option.”