Orion and Bayer further expand the global clinical development program for the oral androgen receptor inhibitor (ARi) darolutamide in prostate cancer.
The new Phase III clinical study, ARASTEP, will investigate the efficacy of darolutamide plus androgen deprivation therapy (ADT) versus ADT alone in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) 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 (PSA) levels with a doubling time of <12 months1 after primary treatment (surgery or radiotherapy). Darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease as well as metastatic hormone-sensitive prostate cancer (mHSPC).
“Darolutamide has already shown its beneficial treatment effects in two patient groups: patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease as well as in patients with metastatic hormone-sensitive prostate cancer in combination with chemotherapy. As a natural continuum we want to assess the potential of darolutamide in the earlier stage of disease, and further expand the patient population that can benefit from darolutamide,” said Outi Vaarala, Senior Vice President of Innovative Medicines and Research and Development at Orion.
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 (ADT) versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating darolutamide as an adjuvant treatment for localised prostate cancer with very high risk of recurrence.
Darolutamide is jointly developed by Orion and Bayer.
Photo of Outi Vaarala: Orion