Darolutamide With Docetaxel and ADT Shows OS Benefit in Metastatic Hormone-Sensitive Prostate Cancer

In the phase 3 ARASENS study, the use of darolutamide with docetaxel and androgen deprivation therapy demonstrated an overall survival advantage for patients with metastatic hormone-sensitive prostate cancer.

Treatment with darolutamide (Nubeqa), compared with placebo, in combination with docetaxel and androgen deprivation therapy (ADT) improved overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).1

The primary end point of the phase 3 ARASENS clinical trial had been met with this result. More details from the study will be presented during an upcoming scientific congress.

“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 Nubeqa with docetaxel and ADT could lead to an increase in overall survival [OS] for men with mHSPC,” said Scott Z. Fields, MD, senior vice president and head of Oncology Development at Bayer's Pharmaceutical Division, in a press release from Bayer. “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.”

ARASENS (NCT02799602) is a randomized, double-blind, placebo-controlled phase 3 study of the oral androgen receptor inhibitor, darolutamide versus placebo in patients with mHSPC. In addition to OS, the study evaluated time to castration-resistant prostate cancer, time to initiation of subsequent antineoplastic surgery, symptomatic skeletal event-free survival, time to first symptomatic skeletal event, time to initiation of opioid use, time to pain progression, time to worsening of physical symptoms of disease, and the number of patients with adverse events as secondary end points.2

To be eligible for the study, patients were required to have a histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate, metastatic disease, be candidates for ADT and docetaxel, have an ECOG performance status of 0 or 1, and adequate bone marrow, liver, and renal function.

Patients were excluded from the study if they were previously treated with androgen receptor inhibitors, CYP17 enzyme inhibitors, radiotherapy, and radiopharmaceuticals. Cardiac events like stroke, myocardial infarction, angina, and congestive heart failure within 6 months of the study were grounds for exclusion. Patients who had a prior malignancy were permitted to enroll, but gastrointestinal (GI) disorder was considered to be a factor that may interfere with study treatment, and therefore, patients with GI disorders were excluded.

Darolutamide is an FDA-approved therapy for the treatment of non-metastatic castration-resistant prostate cancer. Now, several studies are investigating the agent for the treatment of other prostate cancer subtypes like mHSPC in the ARANOTE trial (NCT04736199), and localized prostate cancer with a very high risk of recurrence in the adjuvant setting (DAL-HiCaP; NCT04136353).1


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/3Dl09ok

2. ODM-201 in addition to standard adt and docetaxel in metastatic castration sensitive prostate cancer (ARASENS). Clinicaltrials.gov. Accessed December 3, 2021. https://bit.ly/3dhcdwl