Efficacy and safety outcomes of darolutamide in patients with nonmetastatic castration-resistant prostate cancer with comorbidities and concomitant medications from ARAMIS.

Karim Fizazi, Neal D. Shore, Matthew Raymond Smith, Rodrigo Ramos, Robert J. Jones, Guenter Niegisch, Egils Vjaters, Jorge A. Ortiz, Steve Liang, Yuan Wang, Shankar Srinivasan, Toni Sarapohja, Frank Verholen

Research output: Contribution to journalMeeting Abstractpeer-review


256Background: Patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) are primarily older, have comorbidities, and take concomitant medications. Darolutamide (DARO), a structurally distinct and highly potent androgen receptor inhibitor, significantly reduced the risk of metastasis by ̃2 years and the risk of death by 31% versus placebo (PBO) and demonstrated favorable safety and tolerability in the phase 3 ARAMIS trial. DARO also has low potential for drug−drug interactions. This post hoc analysis of ARAMIS evaluated overall survival (OS) and safety in pts with ongoing comorbidities and concomitant medications. Methods: Pts with nmCRPC were randomized 2:1 to DARO (n=955) or PBO (n=554) while continuing androgen-deprivation therapy. At the final data cutoff (Nov 15, 2019), OS and adverse events (AEs) were evaluated in pts with a median of ≤ and >6 comorbidities or ≤ and >10 concomitant medications in the double-blind period. HRs (95% CIs) were determined from univariate analysis using Cox regression. Results: The majority of pts had ≥6 comorbidities (53%; 795/1509) or received ≥10 concomitant medications (54%; 813/1509). For pts with ≤6 and >6 comorbidities, DARO prolonged OS vs PBO (HR 0.65 and 0.73, respectively). OS benefit of DARO vs PBO was consistent for pts with metabolic, cardiovascular (CV), and other comorbid disorders (HR range: 0.39–0.88). For pts receiving ≤10 and >10 concomitant medications, OS was prolonged with DARO vs PBO (HR 0.76 and 0.66, respectively). Subgroups of pts receiving concomitant medications for gastrointestinal/metabolic disorders, CV disease, urologic disorders, and pain/inflammation achieved similar OS benefit with DARO vs PBO (HR range: 0.45–0.80). Incidence of AEs and AEs leading to treatment discontinuation with DARO was comparable to PBO across subgroups by number of comorbidities and concomitant medications (Table). Conclusions: The OS benefit and safety of DARO remained consistent with that observed in the overall ARAMIS population, even in patients with a high number of comorbidities or concomitant medications. Clinical trial information: NCT02200614. [Table: see text]
Original languageEnglish
Pages (from-to)256-256
Number of pages1
JournalJournal of Clinical Oncology
Issue number6 suppl.
Publication statusPublished - 20 Feb 2022
Externally publishedYes
EventASCO (American Society of Clinical Oncology) Genitourinary Cancers Symposium - Moscone West, San Francisco, CA/ and Online, San Francisco, United States
Duration: 17 Feb 202219 Feb 2022

Field of Science*

  • 3.2 Clinical medicine

Publication Type*

  • 3.3. Publications in conference proceedings indexed in Web of Science and/or Scopus database


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