Genentech’s Phase III lupus nephritis trial fails endpoint

Genentech, a biotechnology company, and US-based Biogen Idec have announced that a Phase III study of Rituxan plus mycophenolate mofetil and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks.

The primary endpoint evaluated improvements in kidney response as measured by standard laboratory tests used to assess kidney health. A preliminary analysis of the safety data did not reveal any new or unexpected safety signals in patients receiving Rituxan.

This Phase III randomized, double-blind, placebo-controlled, multi-center study included 144 patients with class III or IV lupus nephritis from approximately 60 sites in the US, Canada, Mexico, Argentina and Brazil. Study participants were treated with mycophenolate mofetil (MMF) and corticosteroids and were randomized 1:1 to receive Rituxan or placebo in two infusions, 15 days apart.

The patients were re-treated six months later with the same regimen. MMF, an immunosuppressive drug, is commonly used in the treatment of lupus nephritis. Patients were evaluated for efficacy at weeks 24 and 52. The majority of patients are being monitored for at least 78 weeks.

The primary endpoint of the study was the proportion of patients who achieved a complete renal response or partial renal response after 52 weeks of treatment as assessed by improvements in renal function, urinary sediment and proteinuria. Detailed safety data from the study is currently being evaluated.

Hal Barron, chief medical officer of Genentech, said: We are disappointed that Rituxan did not show a significant benefit in patients with lupus nephritis, a complex and serious disease. Using the insights from this study, we will continue to look for new approaches to the treatment of lupus.