Lilly Halts Tabalumab Development for Lupus

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Eli Lilly said today it will end Phase III development of tabalumab for systemic lupus erythematosus (SLE), following its failure in a second pivotal study—the second time in less than two years it has aborted a development program associated with the anti-BAFF (B cell activating factor) monoclonal antibody.

Lilly said safety concerns did not drive its decision to not move forward with regulatory filings on tabalumab for SLE. Instead, the company cited disappointing results from two Phase III trials within its ILLLUMINATE clinical program.

In ILLUMINATE 1, tabalumab did not achieve the primary endpoint compared to standard of care therapy, at either dose studied, of statistically significant improvement on SRI-5 (SLE Responder Index-5, a measurement of lupus disease activity and response).

Lilly had somewhat better results in ILLUMINATE 2, as the higher dose of tabalumab given to patients met the SRI-5 endpoint—the first time a lupus study achieved that efficacy measure as a primary endpoint, according to the company.

However, “collectively, the data from these studies did not meet expectations for efficacy in the context of existing treatments.” Lilly said it will work with investigators to end the studies.

“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,” J. Anthony Ware, M.D., svp, product development, Lilly Bio-Medicines, said in a statement.

Dr. Ware added: “Lilly remains committed to developing potential new medicines for the treatment of autoimmune conditions, including lupus.”

Lilly said it will disclose detailed data from the trials “in appropriate upcoming scientific venues” it did not specify.

In connection with tabalumab for SLE, the pharma giant will take a $75 million charge against third-quarter earnings, which are due to be released October 23.

Last year Lilly wrote off “approximately” $60 million after halting development of tabalumab for rheumatoid arthritis, in the process ending three Phase III trials. That decision came a month after the company ended the Phase III FLEX-M study, citing data showing that tabalumab failed to show sufficient efficacy—while maintaining that its decision did not reflect any safety problems with the compound.

FLEX-M’s failure made GEN’s List of “Top 10 Clinical Trial Failures of 2013,” published in January.

According to ClinicalTrials.gov, tabalumab has been studied for multiple myeloma in recent trials—a Phase II study of the compound in combination with dexamethasone and bortezomib, completed as of August 1; and a Phase I study in Japanese patients of tabalumab in combination with bortezomib and dexamethasone, which was ongoing but not recruiting patients as of September 3.

Tabalumab is among Lilly candidates to have fared disappointingly in late-stage trials. Last year Lilly wrote down a combined $105 million connected with tabalumab and two other compounds: 

  • In December 2013, the antidepressant drug candidate edivoxetine (LY2216684) failed to meet its primary endpoint in three Phase III trials of superior efficacy after eight weeks of treatment.
  • In May 2013, Lilly ended development of enzastaurin (LY317615) after the compound missed its endpoint of statistically significant increase compared to placebo in disease-free survival in patients at high risk of diffuse large B-cell lymphoma (DLBCL) relapse following rituximab-based chemotherapy, in the Phase III PRELUDE study

Also last year, the Alzheimer’s disease candidate solanezumab missed Phase III cognitive and functional primary endpoints against beta-amyloid plaques. However, the program was continued in a population of patients with an earlier stage of the disease.








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