Phase III trial with Nubeqa™ (darolutamide) in combination with docetaxel and androgen deprivation therapy meets primary endpoint
The Phase III ARASENS trial investigating the use of the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in metastatic hormone-sensitive prostate cancer (mHSPC) has met its primary endpoint. In the ARASENS trial, darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) significantly increased overall survival (OS) compared to docetaxel and ADT. The overall incidence of reported adverse events was similar between treatment arms. Detailed results of the study are planned to be presented at an upcoming scientific congress. The ARASENS trial is the only Phase III randomized, multi-center, double-blind trial which was prospectively designed to evaluate the efficacy and safety of a combination of an ARi with docetaxel and ADT compared to docetaxel and ADT in patients with mHSPC.
Darolutamide is approved in multiple markets around the world, including the U.S., the European Union (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. Filings in other regions are underway or planned. The product is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.
“For patients with mHSPC, there remains a significant need for new therapeutic approaches that improve treatment outcomes. ARASENS was prospectively designed to investigate whether combining darolutamide with docetaxel and ADT could lead to an increase in overall survival for men with mHSPC,” said Scott Z. Fields, M.D., Senior Vice President and Head of Oncology Development at Bayer's Pharmaceutical Division. “We are especially grateful to the patients and investigators for participating in this important trial and look forward to presenting the full results at an upcoming meeting.”
Bayer plans to discuss the data from ARASENS with health authorities worldwide regarding the submission for marketing authorization in this indication.
About Nubeqa™ (darolutamide)
Darolutamide is an oral androgen receptor inhibitor (ARi) with a distinct chemical structure that binds to the receptor with high affinity and exhibits strong antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans.
December 03, 2021