Telix to Supply Illuccix for Bayer’s Global Phase III Prostate Cancer Study

Telix Pharmaceuticals Ltd. has entered into an agreement with Bayer AG to supply Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection) for the Phase III ARASTEP study. This global study is investigating the efficacy of Bayer’s androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence who have no evidence of metastatic disease by conventional imaging and a positive PSMA-PET/CT[2] at baseline. 

 

The study will enroll up to 750 patients across various sites in Europe, Japan and the U.S. The more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans.

 

Telix Chief Medical Officer, Dr Colin Hayward said, “We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix’s unique commitment to delivering advanced prostate cancer imaging globally. The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool.”