Genentech and Biogen Idec’s Phase II/III study of Rituxan for systemic lupus erythematosus (SLE) did not meet its primary endpoint of a major clinical response (MCR) or partial clinical response (PCR), compared to placebo at 52 weeks. The study also did not meet any of the six secondary endpoints. The companies have a separate ongoing late-stage study in lupus nephritis, an inflammation of the kidneys, and results from that study are expected in 1Q2009.
    
“We are disappointed in the results of this Phase II/III study, but we understood from the outset the significant challenges in developing treatments for systemic lupus erythematosus,” said Hal Barron, M.D., Genentech senior vice president, development and chief medical officer. “We believe the ongoing Phase III trial in lupus nephritis (LUNAR) remains an important study as it evaluates the potential of Rituxan in a different patient population.”
   
“There is a critical need to discover new therapeutic pathways in lupus as no new therapy has been approved in more than 30 years. We will analyze the full set of data from this trial in the coming months, share the findings with regulatory authorities, and apply the key insights to our continued research in lupus,” said Evan Beckman, M.D., Senior Vice President, Immunology R&D, Biogen Idec.
   
Rituxan is currently approved to treat non-Hodgkins lymphoma and rheumatoid arthritis.