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Darolutamide Improves Survival in Nonmetastatic CRPC

Gina Columbus
Published: Thursday, Jan 30, 2020

Prostate Cancer
Darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) led to a significant improvement in overall survival (OS) compared with placebo and ADT in patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to results from a preplanned final OS analysis of the phase III ARAMIS trial.1

The international, double-blind, placebo-controlled, phase III ARASENS study is exploring darolutamide plus ADT in combination with docetaxel in approximately 1300 patients with newly diagnosed, metastatic hormone-sensitive prostate cancer (NCT02799602).


  1. Nubeqa (darolutamide) plus androgen deprivation therapy achieved the secondary endpoint of overall survival (OS) in men with non-metastatic castration-resistant prostate cancer [news release]: Whippany, NJ. Bayer. Published January 30, 2020. Accessed January 30, 2020.
  2. Fizazi K, Shore N, Tammela TL, et al. Darolutamide in nonmetastatic, castration-resistant prostate cancer. N Eng J Med. 2019;380(13):1235-1246. doi: 10.1056/NEJMoa1815671.
  3. Fizazi K, Shore ND, Tammela T, et al. ARAMIS: efficacy and safety of darolutamide in nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol. 2019;37(suppl 7s; abstr 140). doi: 10.1200/JCO.2019.37.7_suppl.140.
  4. Fizazi K, Shore ND Tammela T, et al. Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic castrate-resistant prostate cancer (nmCRPC). J Clin Oncol. 2019;37(suppl 15; abstr 5000). doi: 10.1200/JCO.2019.37.15_suppl.5000.
  5. Pang J S-T, Shore N, Smith MR, et al. Efficacy and safety of darolutamide in non-metastatic castration-resistant prostate cancer (nmCRPC) in the ARAMIS trial. Ann Oncol. 2019;30(suppl_9):mdz424.001. doi: 10.1093/annonc/mdz424.001.

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