New subgroup data from the Phase III ARASENS trial show overall survival (OS) benefits of darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with high and low-volume, as well as high and low-risk, metastatic hormone-sensitive prostate cancer (mHSPC), compared to ADT with docetaxel. The overall incidence of adverse events continues to be similar between treatment arms. The full results were presented at an oral presentation during the ASCO GU Congress 2023 and simultaneously published in the Journal of Clinical Oncology.

“These latest findings from the ARASENS trial continue to reinforce the strong efficacy and favorable safety profile of darolutamide in mHSPC,” said Maha Hussain, M.D., Genevieve Teuton Professor of Medicine in the Division of Hematology Oncology, Department of Medicine, and the Deputy Director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, Chicago, USA. “The growing data from the ARASENS trial continue to demonstrate darolutamide’s value in treating patients with mHSPC. The benefit is especially in those with high-volume or high-risk disease. They also provide treating physicians with greater insight into the mHSPC patient population that may benefit from this therapy.”

“Despite recent advances, there still remains a need for treatments that extend survival and delay disease progression while maintaining quality of life. This latest subgroup analysis from the ARASENS trial highlights darolutamide’s potential to become a foundational therapy for patients with various types of metastatic disease burden,” said Tara Frenkl, M.D., Senior Vice President and Head of Oncology Development at Bayer. “An important part of our mission at Bayer is to transform prostate cancer care and improve patient outcomes at various stages of the disease. We are working to ensure that as many eligible patients as possible have the opportunity to benefit from darolutamide.”

Darolutamide is being investigated in a broad development program with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish Pharmaceutical company.