Darolutamide Improved Survival Outcomes for Patients With Castration-Resistant Prostate Cancer and Substantial Comorbidity Burden

In a post hoc analysis of the ARAMIS study evaluating a subgroup of patients with castration-resistant prostate cancer with high numbers of comorbidities or concomitant medications, darolutamide exhibited a consistent survival benefit and safety profile to that of the general population in the study.

In the multinational, double-blind phase 3 ARAMIS study, patients with non-metastatic castration-resistant prostate cancer were randomized on a 2-to-1 basis to receive either darolutamide (n = 955) or placebo (n = 554), while continuing androgen-deprivation therapy. It has previously been reported that darolutamide significantly improved the metastasis-free survival and reduced the risk of death compared to placebo and had a favorable safety profile. In this study, the overall survival (OS) and treatment-emergent adverse events were analyzed among subgroups of patients categorized by median number of ongoing comorbidities and concomitant medications.

Among patients with ≤6 and >6 comorbidities, the overall survival was improved with darolutamide compared to placebo (hazard ratio [HR], 0.65; and 0.73, respectively). This improvement was also seen among patients taking ≤10 and >10 concomitant medications (HR, 0.76; and 0.66, respectively), with the benefit remaining consistent across medication types. The numbers of treatment-emergent adverse events and treatment-emergent adverse events which led to discontinuation were similar between darolutamide and placebo across all subgroups.

Study authors concluded, “The [overall survival] benefit of darolutamide remained consistent with that observed in the overall ARAMIS population, even in patients with high numbers of comorbidities or concomitant medications.”

Source:

Fizazi K, Shore ND, Smith M, et al. Efficacy and safety outcomes of darolutamide in patients with nonmetastatic castration-resistant prostate cancer with comorbidities and concomitant medications from the randomized phase 3 ARAMIS trial. Eur J Cancer. Published July 27, 2023. doi:10.1016/j.ejca.2023.113258