Background: In the phase 3 ARAMIS trial, darolutamide (DARO) significantly improved metastasis-free survival (MFS) in patients with nmCRPC
and PSADT ≤10 months. Patients in ARAMIS were stratified by PSADT
≤6 months and >6 months. Here we present the efficacy and safety of
DARO in ARAMIS participants with a PSADT >6 months.
Materials: The double-blind, placebo-controlled phase III ARAMIS trial
randomized 1509 patients with nmCRPC and PSADT ≤10 months in a
2:1 ratio to receive DARO 600 mg twice-daily (n=955) or placebo (PBO;
n=554), while continuing androgen deprivation therapy. Patients were
stratified by PSADT (≤6 months or >6 months) to assess the effect on
efficacy and safety.
Results: In the overall population, median (range) baseline PSADT was
4.4 (0.7-11.0) months in the DARO arm and 4.7 (0.7-13.0) months in the
PBO arm. Around 30% of patients in each arm had PSADT >6 months.
In the subgroup of patients with PSADT >6 months, the risk of metastasis or death was reduced by 62% with DARO as compared with PBO
(hazard ratio [HR] 0.38; 95% confidence interval [CI] 0.26-0.55), in line
with both the overall population (HR 0.41; 95% CI 0.34-0.50) and with
patients with PSADT ≤6 months (HR 0.41; 95% CI 0.33-0.52). Median
(95% CI) MFS was not estimable (40.5 months-not estimable) and 34.3
months (30.8 months-not estimable) for patients with PSADT >6 months
and ≤6 months, respectively. At interim analysis, HR for improved OS vs
PBO showed a similar trend. The safety profile of DARO, including AEs of
interest, for patients with PSADT >6 months was consistent with that of
the overall study population.
Conclusions: The MFS benefit and safety of DARO is similar in the subset of patients with PSADT >6 months and the overall ARAMIS study
- 3.2 Clinical medicine
- 3.1 Basic medicine
- 3.3. Publications in conference proceedings indexed in Web of Science and/or Scopus database