Englander Institute for Precision Medicine

Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial.

TitleEfficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy and Docetaxel in Black Patients From the Randomized ARASENS Trial.
Publication TypeJournal Article
Year of Publication2024
AuthorsShore ND, Hussain M, Saad F, Fizazi K, Sternberg CN, Crawford D, Tombal B, Nordquist L, Cookson M, Verholen F, Jhaveri J, Srinivasan S, Smith MR
JournalOncologist
Volume29
Issue3
Pagination235-243
Date Published2024 Mar 04
ISSN1549-490X
KeywordsAndrogen Antagonists, Antineoplastic Combined Chemotherapy Protocols, Docetaxel, Humans, Male, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Pyrazoles, Randomized Controlled Trials as Topic
Abstract

BACKGROUND: In the ARASENS trial (NCT02799602), darolutamide in combination with androgen-deprivation therapy (ADT) and docetaxel significantly reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001) compared with placebo plus ADT with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC). We present efficacy and safety of darolutamide versus placebo in Black patients from ARASENS.

PATIENTS AND METHODS: Patients with mHSPC were randomized 1:1 to darolutamide 600 mg or placebo twice daily in combination with ADT and docetaxel. The primary endpoint was overall survival. Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and safety.

RESULTS: In ARASENS, 54 Black patients received darolutamide (n = 26) or placebo (n = 28) plus ADT and docetaxel. In Black patients, overall survival favored darolutamide versus placebo (median, not reached vs. 38.7 months; stratified HR, 0.41; 95% CI, 0.17-1.02), with 4-year survival rates of 62% versus 41%. The darolutamide group also had longer time to CRPC compared with the placebo group (median, not reached vs .12.6 months; HR, 0.09; 95% CI, 0.02-0.30). The safety profile of darolutamide in Black patients was consistent with that observed for the overall ARASENS population (grade 3/4 treatment-emergent adverse events, TEAEs: 61.5% vs. 66.1%; serious TEAEs: 42.3% vs. 44.8%).

CONCLUSION: In this small population of Black patients with mHSPC from the ARASENS trial, darolutamide was associated with an improvement in survival and time to CRPC and was well tolerated. Efficacy and safety findings in Black patients were consistent with the overall ARASENS population.

DOI10.1093/oncolo/oyad254
Alternate JournalOncologist
PubMed ID37812679
PubMed Central IDPMC10911916
Grant List / / Bayer and Orion Pharma /

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