As reported by Clinical Trials Arena, Genentech and its subsidiary Roche, provided positive Phase III results with the Food and Drug Administration, or the FDA, of their REGENCY trial (NCT04221477) for the CD20-targeting Lupus Nephritis drug Gazyva (Obinutuzumab).  Gazyva is one of only a handful of biologics approved by the FDA in over 5 decades for lupus, and the only CD20-targeted therapy approved for lupus nephritis.

Out of the 271 patients enrolled in the REGENCY trial, 46.4% of participants who got the Gazyva treatment in combination with a standard lupus nephritis therapy achieved complete renal response at 76 weeks. The pool of patients that received the placebo and achieved complete renal response was 33.1%.

The trial’s positive data was presented at the World Congress of Nephrology conference in New Delhi, India.  Genentech confirmed at the conference that these findings were also shared with the European Medicines Agency (EMA) for regulatory review along with the FDA.

REGENCY’s positive findings come out of the shadow of Roche’s previous failed attempt to meet FDA approvals in their Phase III LUNAR trial (NCT00282347) in 2012 for the drug Rituxan (rituximab).  Co-developed by Biogen and Genentech, Rituxan failed to meet endpoint criteria in the LUNAR trial.  Despite this, Rituxan has still become a multibillion-dollar product for Genentech as it is widely used by lupus nephritis patients off-label.  Gazyva is similar to Rituxan in that it targets the CD20 protein in B cells, and the drug is already approved for other conditions like certain leukemias and lymphomas.  Genentech is also considering Gazyva as a potential treatment option for other autoimmune disease.

About Lupus Nephritis

Lupus nephritis is a kind of kidney inflammation that occurs from a complication in people who have systemic lupus erythematosus (commonly just referred to as lupus). Lupus is an autoimmune disease in which your immune system produces proteins, called autoantibodies, that attack your own body. In lupus nephritis, lupus autoantibodies affect the parts of your kidneys that filter out waste, leading to inflammation, hematuria, proteinuria, high blood pressure, or even kidney failure. Lupus is much more common in women than in men, most often occurring during the women’s child-bearing years. In addition, lupus is more common in people of African or Asian descent. Of these lupus cases, half of all adults and eight out of every ten children will develop lupus nephritis.

Sources: Clinical Trials Arena