Based on efficacy results Eli Lilly and Company announced today that it will discontinue the Phase 3 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 3 program for systemic lupus erythematosus, ILLUMINATE, is ongoing and will continue as planned.
In December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-M for lack of treatment effect. 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.
Based on the outcomes of these two separate interim futility analyses, Lilly has decided to discontinue development of tabalumab in the current RA program. All ongoing Phase 2 and Phase 3 RA studies will be stopped.
"While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas," said Eiry Roberts, M.D., vice president of autoimmune product development at Lilly. "Autoimmune disorders are highly individualized. We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing Phase 3 tabalumab lupus program." The decision to stop the current RA program for tabalumab is expected to result in a first-quarter charge to research and development expense of approximately $50 million. The company's previously issued financial guidance for 2013 remains unchanged.