KEY TAKEAWAYS
- The ARANOTE phase III trial compared the effectiveness of DARO plus ADT vs ADT alone in patients with mHSPC.
- The primary endpoint was to determine rPFS.
- The DARO showed significant efficacy and good tolerability in mHSPC.
In the ARASENS trial, combining darolutamide (DARO) with androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival (OS) compared to ADT plus docetaxel alone for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The incidence of treatment-emergent adverse events (TEAEs) was similar across both treatment groups.
Fred Saad and the team aimed to compare the efficacy of DARO plus ADT versus ADT alone in patients with mHSPC.
The inclusion criteria for eligible patients was mHSPC, confirmed by imaging, with an ECOG performance status of 0-2 and had started ADT within the past 12 weeks.
The selected patients were randomly assigned in a 2:1 ratio to receive either DARO 600 mg twice daily or a placebo, both along with ADT. The primary goal was to measure radiological progression-free survival (rPFS), while secondary goals included OS, time to further therapy, and safety.
The results showed that 669 patients were enrolled (DARO: 446; placebo: 223), with a median age of 70 years. Of all, 31% were Asian, 9.7% were Black, the median PSA at baseline was 21.3 ng/mL, and 71% had high-volume HSBC. The DARO + ADT combination significantly improved rPFS compared to placebo + ADT (HR 0.54; 95% CI: 0.41-0.71, P<0.0001), showing consistent benefits across different patient subgroups.
DARO also demonstrated a positive trend in OS (HR 0.81; 95% CI: 0.59-1.12) and showed benefits in secondary endpoints like time to CRPC (HR 0.40; 95% CI: 0.32–0.51), PSA progression (HR 0.31; 95% CI 0.23–0.41), subsequent therapy (HR 0.40; 95% CI, 0.29–0.56) and pain progression (HR 0.72, 95% CI: 0.54-0.96). The TEAE was similar between groups, with fewer discontinuations due to adverse events (AEs) in the DARO group (6.1% vs. 9.0%).
The study concluded that DARO demonstrates strong efficacy and favorable tolerability in mHSPC, as confirmed by ARANOTE. ARASENS and ARANOTE show DARO’s benefits with and without chemotherapy, offering personalized treatment options with minimal progression and treatment burden.
The trial was sponsored by Bayer.
Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/18
Clinical Trials: https://clinicaltrials.gov/study/NCT04736199
Saad F, Vjaters E, Shore ND, et al. (2024). “Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial.” Presented at ESMO-2024 (Abstract LBA68)
