Lilly halts development of tabalumab for lupus at phase III

Eli Lilly is to discontinue development of tabalumab for the treatment of systemic lupus erythematosus (SLE, commonly known as lupus) owing to disappointing results in two phase III trials.

In the ILLUMINATE 1 study, tabalumab did not achieve a statistically significant improvement on SRI-5 (SLE Responder Index-5), compared to standard of care therapy. In ILLUMINATE 2, the higher dose met this endpoint but, collectively, the data showed the drug did not work better than existing treatments.

“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 Dr J Anthony Ware, senior vice president, product development, Lilly Bio-Medicines. “The ILLUMINATE trials are the largest phase III clinical studies in lupus to date and 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.”

Responding to the news, Sandra Raymond, president and CEO of the Lupus Foundation of America said that, although the top-line results of the trials were not favourable, the evidence supported further examination of the data. “The results underscore that the pathway this drug targets (B-cell) is known to be critical in the development of lupus,” she stated.

She called for federal agencies like the US Food and Drug Administration (FDA) to make lupus a higher priority and to focus on how clinical trials were designed and conducted: “While the FDA has named lupus as an important disease in its Critical Path Initiative, it has yet to allow a lupus development programme that keeps pace with 21st century medicine.”

Innovative trial design was needed in lupus, she continued, adding that current FDA guidelines to test potential new drugs for lupus did not allow true understanding of the reasons for failures in lupus clinical trials: “We don’t know whether it is the investigational drug, the design of the clinical trial or other factors that cause trials to be unsuccessful.”

Despite the failure of tabalumab, she pointed to the fact that there were several other promising treatments in the near-term pipeline. She also highlighted the Foundation’s Collective Data Analysis Initiative (CDAI), which analyses data from past lupus clinical trials to see how other drugs that participants are allowed to take during lupus clinical trials might mask the effectiveness of potential new treatments.

GlaxoSmithKline’s Benlysta (belimumab) was approved for SLE in 2011 and was the first treatment for lupus in over 50 years.

Lupus is a chronic, autoimmune disease that can damage any part of the body (skin, joints, and/or organs inside the body), and ranges from mild to life-threatening. The Foundation estimates that up to 1.5 million people in the US and five million people throughout the world have a form of lupus. Lupus strikes mostly women of childbearing age (15-44), though men, children and teenagers also develop lupus.

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