J&J’s Blockbuster Tremfya Flops in Phase II Giant Cell Arteritis Trial

 Johnson & Johnson is halting a mid-stage trial investigating its monoclonal antibody Tremfya (guselkumab) in giant cell arteritis after it failed to reach the primary endpoint.

According to an update on clinicaltrials.gov, the Phase II THEIA study did not meet the primary endpoint—the percentage of participants achieving glucocorticoid (GC)-free remission—but the exact details were not disclosed. However, the company did find “insufficient efficacy findings” which did not lead to further support for the study, a J&J spokesperson told BioSpace in an email statement. The spokesperson also said no new safety concerns were found.

“This is an indication-specific decision that does not impact other guselkumab development programs, and although this decision is disappointing, Johnson & Johnson remains committed to developing transformational therapies to address rheumatologic diseases for which there is significant unmet need,” the spokesperson said.

The study aimed to pit Tremfya against a placebo in combination with a 26-week glucocorticoid taper regimen in adults with no-onset or relapsing giant cell arteritis (GCA) and enrolled 53 participants. GCA is an autoimmune disease that causes inflammation of the arteries. Left untreated, it can cause headaches, scalp tenderness, jaw pain, and possible blindness.

Other companies are making headway in the giant cell arteritis space as AbbVie announced in April 2024 that a combination of Rinvoq and a steroid taper regimen reached its primary endpoint of sustained remission in adults with GCA between week 12 and week 52. Actemra, made by Roche’s Genentech, was approved by the FDA to treat GCA in 2017.  

Still,  Tremfya has achieved success in other indictations showing positive results in a Phase III study for patients with moderate to severely active ulcerative colitis last year. J&J reported clinical response reached 61.5% for Tremfya patients compared to 27.9% in the placebo group.

In January 2024, the drug also demonstrated a “rapid and significant” clearance in severe scalp psoriasis and improvement in scalp itch in a Phase IIIb study. That same month, J&J applied to the FDA for approval for Tremfya to treat severely active Crohn’s disease.

Tremfya has been a significant earner for J&J, with sales of over $3.1 billion last year and $808 million in the first quarter of 2024.

https://www.biospace.com/article/j-and-j-s-blockbuster-tremfya-flops-in-phase-ii-giant-cell-arteritis-trial/