Bayer, Orion expand clinical development program for darolutamide

Orion and Bayer further expand the global clinical development program for the oral androgen receptor inhibitor darolutamide in prostate cancer. The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy 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 at baseline. BCR is defined as rising prostate-specific antigen levels with a doubling time of less than12 months1 after primary treatment. Darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer, who are at high risk of developing metastatic disease as well as metastatic hormone-sensitive prostate cancer. The compound is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy versus ADT alone for metastatic hormone-sensitive prostate cancer, as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group led international Phase III co-operative group DASL-HiCaP trial evaluating darolutamide as an adjuvant treatment for localised prostate cancer with very high risk of recurrence.