Roche has announced that in the Phase II NOBILITY study, Gazyva (obinutuzumab) more than doubled the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone.
The company confirmed that the drug met its primary endpoint, demonstrating superiority compared to placebo with standard of care.
The patients in the study showed increasing rates of complete renal response (CRR) from week 52 to week 76, with 40% in the Gazyva group achieving CRR, compared to just 18% in the placebo group at week 76.
In addition, Gazyva met key secondary efficacy endpoints showing improved overall renal response (complete or partial renal responses) and serologic markers of disease activity, compared to placebo.
The pharma giant is “very encouraged" by the data, which "suggest that Gazyva may provide a clinically meaningful benefit for adults with proliferative lupus nephritis; a condition for which there is a strong need for more effective and targeted treatment options,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
The treatment, which was granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in September, is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system.
“These results support the continued development of Gazyva for people with lupus nephritis and underscore our longstanding commitment to pursue new treatment options that may benefit the lupus community.”
Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with high-risk of end-stage renal disease and death.