Lilly to Discontinue Development of Tabalumab Based on Efficacy Results in Phase 3 Lupus Studies
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 3 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 3 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.
"Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in one of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies," said
The decision to discontinue development of tabalumab for lupus is expected to result in a third-quarter charge to research and development expense of up to
About systemic lupus erythematosus (SLE)
Systemic lupus erythematosus (also known as lupus) is a chronic, autoimmune disease that can damage any part of the body (skin, joints, and/or organs inside the body), and can range from mild to life-threatening. The
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This press release contains forward-looking statements about tabalumab as a potential treatment for systemic lupus erythematosus and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. For further discussion of these and other risks and uncertainties, see Lilly's filings with the
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