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Darolutamide improves overall survival in mHSPC


Adding darolutamide (Nubeqa) to docetaxel and androgen deprivation therapy (ADT) significantly improved overall survival (OS) versus docetaxel and ADT alone in men with metastatic hormone-sensitive prostate cancer (mHSPC), according to findings from the phase 3 ARASENS trial.1

Safety with the darolutamide regimen was also reported to be comparable to the control arm. Bayer, the developer of the oral androgen receptor inhibitor, reported in a press release that the data from the study will be presented at an upcoming medical meeting, and that the company plans to discuss the results with regulatory agencies worldwide regarding an indication in this setting.

“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 for men with mHSPC,” Scott Z. Fields, MD, senior vice president and head of Oncology Development at Bayer's Pharmaceutical Division, stated in the press release.

Overall, the phase 3 multicenter, double-blind ARASENS trial randomized 1306 newly diagnosed patients with mHSPC in a 1:1 ratio to docetaxel and standard ADT plus either darolutamide (600 mg twice daily) or matching placebo. OS was the primary end point with secondary end points including time to castration-resistant prostate cancer (CRPC), time to initiation of subsequent anticancer therapy, time to first symptomatic skeletal event, time to pain progression, and safety.

Current darolutamide approval

Darolutamide is currently approved for the treatment of patients with nonmetastatic CRPC. The approval was based on data from the double-blind ARAMIS trial, which included 1509 patients with nonmetastatic CRPC. Patients were randomized in a 2:1 ratio to receive oral darolutamide at 600 mg twice daily plus androgen deprivation therapy (ADT; n = 955) or placebo plus ADT (n = 554).

The primary data from the trial showed that in the overall population, the median metastasis-free survival was 40.4 months in the darolutamide cohort and 18.4 months in the placebo cohort, translating to a 59% reduction in the risk of metastases or death (HR, 0.41; 95% CI, 0.34-0.50; P <.001).

Subsequent to the FDA approval, the agency updated darolutamide’s label to include OS data from the ARAMIS trial.2 These data showed that adding darolutamide to ADT reduced the risk of death by 31% compared with ADT plus placebo in men with nonmetastatic CRPC (HR, 0.69; 95% CI, 0.53-0.88; P = .003).3 At a median follow-up of 29 months, the 3-year OS rates were 83% and 77% in the darolutamide and placebo arms, respectively.

This OS benefit was reached even though over half (55%) of the patients on the control arm received darolutamide (n = 170) or other subsequent treatments (docetaxel, abiraterone acetate [Zytiga], enzalutamide [Xtandi], sipuleucel-T [Provenge], and cabazitaxel [Jevtana]) after the study was unblinded.


Darolutamide is also being evaluated in the ongoing double-blind phase 3 ARANOTE trial (NCT04736199), in which men with mHSPC are being randomized to ADT plus either darolutamide or placebo. The primary end point of the ARANOTE trial is radiological progression-free survival.


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. Published online December 3, 2021. Accessed December 3, 2021. https://bwnews.pr/3GbjkTl.

2. U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information. Posted online January 8, 2021. https://bit.ly/2L60YfW. Accessed January 8, 2021.

3. Fizazi K, Shore N, Tammela TL, et al. Nonmetastatic, castration-resistant prostate cancer and survival with darolutamide. N Engl J Med. 2020;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.

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