Roche subsidiary Genentech has reported improved complete renal response (CRR) in proliferative lupus nephritis patients treated with Gazyva (obinutuzumab) in a Phase II NOBILITY clinical trial.
Proliferative lupus nephritis is the most severe form of lupus nephritis, a kidney disorder associated with systemic lupus erythematosus (SLE), and could cause end-stage renal disease and death.
Gazyva is an engineered monoclonal antibody that binds to the CD20 protein present on some B-cells. The drug is believed to attack targeted cells directly and with the body’s immune system.
Genentech is developing the drug in collaboration with Biogen.
The randomised, double-blind, placebo-controlled, multi-centre NOBILITY trial assessed the drug in combination with mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids in 125 adult patients.
The primary endpoint was the proportion of patients with CRR at 52 weeks when compared to placebo combination with MMF or MPA and corticosteroids.
Key secondary endpoints included overall renal responses, comprising complete and partial renal responses, and serologic markers of disease activity.
The trial met the primary endpoint, with Gazyva combination increasing the CRR rates from week 52 to week 76. Compared to 18% in the placebo arm, 40% of patients treated with the drug experienced CRR at week 76.
Genentech’s drug also improved overall renal response and serologic markers of disease activity.
Data did not reveal any new safety signals with the drug. The company added that the drug showed no increase in serious adverse events and serious infections to week 76.
Genentech chief medical officer and Global Product Development head Levi Garraway said: “We are very encouraged by the positive results from the NOBILITY study, 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.”
The company plans to launch a Phase III trial for the drug in lupus nephritis patients next year.