Tabalumab discontinued for Lupus - Eli Lilly

Eli Lilly has announced it will discontinue development of tabalumab­, a monoclonal antibody -- being studied for the treatment of Systemic Lupus Erythematosus (SLE, commonly known as lupus) -- due to insufficient efficacy in two pivotal Phase III trials. The decision was not based on safety concerns. ­­­­In the ILLUMINATE 1 study, tabalumab did not achieve the primary endpoint, at either dose studied, of statistically significant improvement on SRI-5 (SLE Responder Index-5, a measurement of lupus disease activity and response), compared to standard of care therapy.

In ILLUMINATE 2, the higher dose of tabalumab met this endpoint, the first time a lupus study has achieved this efficacy measure as a primary endpoint in a Phase III trial. Collectively, the data from these studies did not meet expectations for efficacy in the context of existing treatments. The overall safety profile showed a similar frequency of adverse events in patients treated with either tabalumab or standard of care. Lilly intends to submit these data for disclosure in appropriate upcoming scientific venues. Given the overall efficacy results from these two pivotal Phase III studies, Lilly will not move forward with submissions to global regulators. Lilly will work with investigators to appropriately conclude these studies in the interest of patient safety.