Lilly discontinues phase 3 RA program for tabalumab

Eli Lilly will discontinue its phase 3 rheumatoid arthritis study of tabalumab for lack of efficacy, the pharmaceutical corporation announced today.

Based on two separate interim futility analyses, all phase 2 and phase 3 studies of tabalumab and patients with rheumatoid arthritis (RA) were halted, the company said.

The decision on tabalumab, an anti-B cell activating factor (anti-BAFF) monoclonal antibody, was not based on safety concerns, according to a company press release. Lilly’s phase 3 ILLUMINATE study of tabalumab for systemic lupus erythematosus will continue.

“While we are obviously disappointed by these results in rheumatoid arthritis, we continue to believe that tabalumab could have significant potential for patients in other disease areas,” Eiry Roberts, MD, vice president of autoimmune product development at Lilly, said. “We believe that targeting BAFF with a molecule such as tabalumab may still represent an important advance for patients, and therefore we will continue the ongoing phase 3 tabalumab lupus program.”

Because of lack of treatment effect, Lilly discontinued its phase 3 RA registration study, FLEX-M, in December. The study was investigating tabalumab in patients with moderate-to-severe RA who had inadequate response to methotrexate. An interim futility analysis was conducted of the FLEX-V study, which evaluated tabalumab in patients with moderate-to-severe RA who responded inadequately to one or more tumor necrosis factor inhibitors.

Lilly reported two other potential medicines in late-stage development: ixekizumab, an anti-IL-17 monoclonal antibody for treating psoriasis and psoriatic arthritis, and baricitinib, a JAK1 and JAK2 inhibitor that is being developed with Incyte Corp. to treat RA, psoriasis and diabetic nephropathy.