ARASENS Phase III trial for prostate cancer treatment meets primary endpoint
pharmafile | December 3, 2021 | News story | Medical Communications |
Orion and Bayer’s Phase III ARASENS trial has demonstrated an increase in overall survival, evaluating darolutamide in combination with docetaxel and androgen deprivation therapy (ADT), compared to docetaxel and ADT, a standard of care in metastatic hormone-sensitive prostate cancer (mHSPC). Bayer aims to present these ground-breaking data at a forthcoming scientific congress, and will discuss them with health authorities.
The Phase III ARASENS trial, investigating the use of the oral androgen receptor inhibitor (ARi) darolutamide in mHSPC, has met its primary endpoint of increased overall survival. ARASENS is part of a development programme for darolutamide, which includes another ongoing Phase III trial in mHSPC, ARANOTE, evaluating darolutamide and ADT.
The ARASENS trial is the only Phase III, randomised, multi-centre, double-blind, placebo-controlled study which was prospectively designed to evaluate the efficacy and safety of an Ari combination with docetaxel and ADT, compared to docetaxel and ADT in patients with mHSPC.
Darolutamide is currently approved in multiple markets worldwide – including the US, EU, Japan, and China, 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.
Professor, MD, PhD Outi Vaarala, Senior Vice President of Research and Development at Orion, commented: “I would like to thank all the patients and investigators participating in the ARASENS study. The results show that darolutamide, a compound discovered by Orion’s scientists, in combination with docetaxel and androgen deprivation therapy improves overall survival for patients with metastatic hormone-sensitive prostate cancer.
“We share with our partner the excitement about this new combination approach as a potential new treatment option for men with mHSPC.”
Lina Adams
