The primary analysis of the phase 3 ARASENS trial (NCT02799602; n=1,305) showed that darolutamide added to ADT and docetaxel resulted in an OS benefit for patients with mHSPC compared with ADT, docetaxel, and placebo2. Now, Prof. Bertrand Tombal (Université Catholique de Louvain, Belgium) presented the OS results of this trial according to the extent of metastatic disease and ALP levels of the patients, which are known prognostic factors in this population3.
The previously reported OS benefit of additional darolutamide over placebo appeared to be consistent in patients with M1b disease (HR 0.66; 95% CI 0.54–0.80) and in patients with M1c disease (HR 0.76; 95% CI 0.53–1.10). Subgroups of patients with ALP levels <upper limit of normal (ULN; HR 0.65; 95% CI 0.47–0.89) and those with ALP levels ≥ULN (HR 0.69; 95% CI 0.56–0.85) experienced comparable OS benefits with darolutamide. Also, the time to castration-resistant prostate cancer was increased with darolutamide therapy in all subgroups. Importantly, darolutamide did not add toxicity to the regimen of ADT and docetaxel. Again, this result was consistent across subgroups.
Prof. Tombal concluded that darolutamide in combination with ADT and docetaxel should become a new standard-of-care therapy in patients with mHSPC.
1. Tombal B, et al. Overall Survival With Darolutamide Versus Placebo in Combination With Androgen-deprivation Therapy and Docetaxel by Stratification Factors in the Phase 3 ARASENS Trial. Game-changing session 5, EAU 2022, 01–04 July.
2. Smith MR, et al. N Engl J Med 2022;386:1132-1142
3. Gravis G, et al. Eur Urol. 2015;68:196-204