Updated results from ARAMIS phase III trial showed darolutamide improves overall survival (OS) over placebo in nmCRPC patients

Overall survival (OS) results of phase III ARAMIS study of darolutamide (DARO) added to androgen deprivation therapy (ADT) for nonmetastatic castration-resistant prostate cancer (nmCRPC)

Abstract Number : 5514

Abstract Type : Poster Discussion Session

Indication : nmCRPC

Intervention : Darolutamide + ADT vs ADT

Company : Bayer AG and Orion Pharma

Technology : Small Molecule


Final analysis was conducted after 254 deaths were observed (15.5% of DARO and 19.1% of PBO patients). After unblinding at the primary analysis, 170 pts crossed over from PBO to DARO. DARO showed a statistically significant OS benefit corresponding to a 31% reduction in the risk of death compared with placebo. All other secondary endpoints were significantly prolonged by DARO (Table), regardless of the effect of crossover and subsequent therapies on survival benefit. Incidences of treatment-emergent adverse events (AEs) with $5% frequency were generally comparable between DARO and PBO, similar to the safety profile observed at the primary analysis. Incidences of AEs of interest (including falls, CNS effects, and hypertension) were not increased with DARO compared with PBO when adjusted for treatment exposure. AEs in the crossover group were consistent with those for the DARO treatment arm.


DARO showed a statistically significant OS benefit for men with nmCRPC. In addition, DARO delayed onset of cancer-related symptoms and subsequent chemotherapy, compared with PBO. With extended follow-up, safety and tolerability were favorable and consistent with the primary ARAMIS analysis


Long term data from ARAMIS study will provide further compelling evidence for early darolutamide treatment in men with nmCRPC

Refer to Metastatic Castration Resistant Prostate Cancer Market report for detailed Insights.