In the Phase III REGENCY study, Gazyva elicited superior complete renal response rates in patients with lupus nephritis versus placebo, positioning Roche’s therapeutic antibody for expansion into the indication.
Roche subsidiary Genentech announced on Thursday that Gazyva (obinutuzumab) met its primary efficacy endpoint in the Phase III REGENCY study of lupus nephritis. The pharma will present these data to the FDA and other global health authorities with the goal of securing approvals in this indication.
Without revealing specific data, Roche in its announcement indicated that Gazyva treatment elicited “statistically significant and clinically meaningful treatment benefits” in patients with active lupus nephritis. At 76 weeks, more patients treated with Gazyva—given on top of standard therapy with mycophenolate mofetil and glucocorticoids—reached complete renal response (CRR) versus standard therapy alone.
Roche CMO Levi Garraway in a statement called this CRR result “robust,” noting that it is “associated with long-term preservation of kidney function and delay or prevention of end-stage kidney disease.”
Gazyva also aced two of its key secondary endpoints in REGENCY, including the proportion of patients hitting CRR alongside a successful reduction in corticosteroid use, as well as an improvement in proteinuric response. Both measures are important markers of disease control in lupus nephritis, according to the company.
Roche said it will share REGENCY’s findings for presentation at an upcoming medical meeting and for publication in a peer-reviewed journal.
Lupus nephritis is a kidney complication caused by the autoimmune disease systemic lupus erythematosus (SLE). In patients with lupus nephritis, B cells cause overactive and persistent inflammation, which damages the kidney and can cause end-stage kidney disease, typically within 10 years. At its most advanced stages, the kidney damage that lupus nephritis causes can only be treated through transplantation or dialysis.
Gazyva is an intravenously administered monoclonal antibody that works by targeting the CD20 surface protein, which is commonly found on immature and mature lymphocytes. Once bound to its target, Gazyva can trigger cell death, ultimately leading to an overall decline in the levels of disease-causing B cells.
This mechanism of action has won Gazyva several FDA approvals, including for chronic lymphocytic leukemia and follicular lymphoma. Roche is continuing to advance Gazyva into other B cell-mediated diseases, including membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and SLE.
Gazyva’s late-stage victory on Thursday continues the industry’s recent winning streak in the autoimmune space. Earlier this week, partners Biogen and UCB reported that their investigational therapy dapirolizumab pegol cleared the Phase III PHOENYCS GO study in SLE, demonstrating significant improvements in moderate-to-severe disease activity versus placebo.
Last month, startup Navigator Medicines raked in $100 million in its Series A funding round, which it will use to develop its bispecific antibody NAV-240 for autoimmune conditions.
