Darolutamide Combo Significantly Increased Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

The phase 3 ARASENS trial, which assessed the use of darolutamide and docetaxel in patients with metastatic hormone-sensitive prostate cancer, met its primary end point of significantly improved overall survival.

A combination of the oral androgen receptor inhibitor darolutamide (Nubeqa), docetaxel, and androgen deprivation therapy (ADT) was found to significantly improve overall survival (OS) in a population of patients with metastatic hormone-sensitive prostate cancer (mHSPC), according to findings from the phase 3 ARASENS study (NCT02799602).1

The trial's primary end point of improved OS with the addition of darolutamide was met, according to investigators. Moreover, it was reported that the incidence of adverse effects (AEs) was similar between the 2 treatment arms. Findings from the study are expected to be presented at an upcoming scientific congress.

Drug developer Bayer intends to discuss findings from the study with global health authorities in order to submit a marketing authorization for darolutamide in this indication.

“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,” Scott Z. Fields, MD, senior vice president and head of oncology development of the Pharmaceutical Division at Bayer, said in a press release. “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.”

The goal of the randomized, multicenter, double-blind study was to evaluate the safety and efficacy of combining an androgen receptor inhibitor with docetaxel and ADT vs docetaxel and ADT alone.

A total of 1306 patients with newly diagnosed disease were randomized 1:1 to be treated with either 600 mg of darolutamide plus standard docetaxel and ADT or the docetaxel ADT backbone alone.

Secondary end points for the study include time to castration-resistant prostate cancer, time to initiation of subsequent antineoplastic therapy, time to symptomatic skeletal event-free survival, time to opioid use, time to pain progression, time to worsening of physical symptoms, and safety.

In order to be eligible for the trial, patients were required to have histologically or cytologically confirmed adenocarcinoma of the prostate and metastatic disease. Patients needed to be candidates for both ADT and docetaxel and have started ADT with or without a first-generation anti-androgen. Additionally, an ECOG performance status of 0 or 1 and adequate bone marrow, liver, and renal function were required.

In January 2021, the FDA approved a supplemental new drug application for darolutamide in patients with non-metastatic castration-resistant prostate cancer.2 The indication was based on findings from the phase 3 ARAMIS trial (NCT02200614), which found that darolutamide in addition to ADT reduced the risk of death by 31% compared with placebo (HR, 0.69; 95% CI, 0.53-0.88; P = .003). The 3-year OS rates in the darolutamide and placebo arms were 83% and 77%, respectively.


  1. Phase III investigational trial of NUBEQA® (darolutamide) in combination with docetaxel and androgen deprivation therapy (ADT) meets primary endpoint of significantly increasing overall survival (OS) in patients with mHSPC. News release. Bayer. December 3, 2021. Accessed December 3, 2021. https://bit.ly/3lAa8jL
  2. U.S. FDA approves addition of overall survival and other secondary endpoint data to Nubeqa (darolutamide) prescribing information. News release. Bayer January 8, 2021. Accessed December 3, 2021. https://bit.ly/3lyfADE