Roche has secured a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its Gazyva (obinutuzumab) to treat adults with lupus nephritis.
The status was provided based on data from the phase II NOBILITY study in adult patients with proliferative lupus nephritis.
Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), showed enhanced efficacy compared against placebo plus standard of care alone in achieving complete renal response at one year in the study.
Gazyva is an engineered monoclonal antibody developed to attach to CD20, a protein present only on certain types of B-cells. Gazyva is part of a collaboration between Genentech and Biogen in the US.
Lupus nephritis is a manifestation of systemic lupus erythematosus that will result from inflammation of the kidneys. It is associated with a high risk of end-stage renal disease or death.
The NOBILITY is a randomised, double-blind, placebo-controlled and multi-centre study designed to compare the safety and efficacy of Gazyva, in combination with mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids, to placebo, combined with MMF or MPA and corticosteroids, in adult patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis.
Roche recruited 126 patients who were randomised to secure Gazyva or placebo infusions on days one, 15, 168, and 182.
The proportion of participants who achieved a protocol-defined complete renal response (CRR) at 52 weeks is the primary endpoint of the study.
According to the company, the study achieved its primary endpoint and major secondary endpoints demonstrating improved overall renal responses and serologic markers of disease activity as compared to placebo.
Roche chief medical officer and global product development head Dr Sandra Horning said: “New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women.
“We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase III trial next year.”