Orion announced Phase III ARANOTE trial of darolutamide in combination with androgen deprivation therapy in men with metastatic hormone-sensitive prostate cancer meets primary endpoint. Orion and Bayer?s Phase III ARANOTE trial meets primary endpoint, significantly increasing radiological progression-free survival with darolutamide + androgen deprivation therapy compared to placebo plus ADT. Safety analysis shows darolutamide plus ADT to be comparable to placebo plus ADT, reconfirming the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials.

Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal phase III studies in metastatic hormone-sensitive prostate cancer. Bayer plans to present the pivotal data at a forthcoming scientific congress and prepare for submission with health authorities globally to extend the indication of darolutamide. The Phase III ARANOTE trial, investigating darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer, has met its primary endpoint of rPFS.

Darolutamide plus ADT significantly increased rPFS compared to placebo plus ADT. The safety data were comparable between both treatment arms and reconfirm the established tolerability profile of darolutamide in advanced prostate cancer. 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, and patients with metastatic hormone-sensitive prostate cancer Detailed results of the ARANOTE trial are planned to be presented at a forthcoming scientific congress.

Bayer plans to submit the data from the study to relevant global health authorities to support expanded use of darolutamide in men with mHSPC. ARANOTE is part of a robust clinical development program investigating darolutamide across various stages of prostate cancer, which includes the Phase III ARASTEP trial evaluating darolutamide plus ADT versus ADT alone in hormone-sensitive high-risk biochemical recurrence prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline. Furthermore, darolutamide is also being investigated by Bayer in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group.

The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. A total of 669 patients were randomized to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT.

The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration-resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments.