Tabalumab failed to establish efficacy compared with current standard of care therapy in 2 pivotal late-stage trials.
Eli Lilly and Company has discontinued development of its experimental systemic lupus erythematosus (SLE) treatment, tabalumab, given the drug failed to establish efficacy in 2 pivotal late-stage trials.
In the ILLUMINATE research studies, the largest phase 3 clinical trials regarding SLE to date, tabalumab did not meet expectations for effectiveness compared with current standard of care therapy. While the higher dose of the drug achieved statistically significant improvement on a measurement of lupus disease activity and response in one trial, neither dose of tabalumab met that primary end point in another study.
Although Lilly will not pursue regulatory approvals for the drug, the company intends to disclose the trial data in upcoming scientific venues.
“Although we were pleased that tabalumab met the criteria for statistically significant improvement in the SRI-5 endpoint in 1 of our trials, we are nonetheless disappointed that the overall results did not meaningfully improve the condition of the patients in these studies,” said J. Anthony Ware, MD, senior vice president of product development for Lilly Bio-Medicines, in a press release. “We are hopeful that our contribution of the extensive data from these studies will advance knowledge to enhance treatment in this devastating illness. Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus.”
Lilly stressed that its decision to discontinue development of tabalumab was not based on safety concerns, as patients treated with either the drug or standard of care reported similar frequency of adverse events in the ILLUMINATE trials.