Lack of efficacy causes Eli Lilly to drop Ph III RA program for tabalumab

US drug major Eli Lilly (NYSE: LLY) says that it will discontinue the Phase III rheumatoid arthritis (RA) program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, due to lack of efficacy.

The decision was not based on safety concerns. The tabalumab Phase III program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned, the company said.

Late last year, Lilly discontinued the Phase III RA registration study FLEX-M for lack of treatment effect (The Pharma Letter December 14, 2012). FLEX-M was investigating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy. Based on FLEX-M findings, an interim futility analysis was conducted of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors.