Dr. Maha Hussain highlights results of secondary analysis of ARASENS trial

Maha Hussain, MD, FACP, FASCO, discusses results from a secondary analysis of the phase 3 ARASENS trial, which she presented at the 2023 Genitourinary (GU) Cancers Symposium.¹

The previously reported primary analysis of the ARASENS trial led to the FDA approval of darolutamide (Nubeqa) for use in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).² The study showed that adding darolutamide to standard androgen deprivation therapy (ADT) and docetaxel boosted overall survival (OS) versus ADT/docetaxel alone in patients with mHSPC.

The secondary analysis Hussain presented at the GU Symposium showed that the risk of death was reduced by 32% across all volume and subgroups in men with mHSPC treated with the darolutamide-based triplet regimen.

Darolutamide plus ADT and docetaxel prolonged OS regardless of disease volume or risk. Median OS was not reached for those with high-volume disease (HR, 0.69) or low-volume disease (HR, 0.68). Median OS was also not reached in both the high-risk disease subgroup (HR, 0.71) and the low-risk disease subgroup (HR, 0.62) with the darolutamide triplet.

The darolutamide regimen also clinically improved key secondary endpoints in high-/low-volume and risk subgroups, compared with placebo, with HRs in the range of those observed in the general population. This included time to progression to castration-resistant prostate cancer, which favored the darolutamide combination in both the high- (HR, 0.41) and low-volume (HR, 0.21) disease groups, as well as the high- (HR, 0.38) and low-risk groups (HR, 0.32).

Incidence of treatment-emergent adverse events were consistent with the overall population across subgroups by high-/low-volume and high-/low-risk.

Hussain, is the Genevieve Teuton Professor of Medicine in the Division of Hematology-Oncology, Department of Medicine, and the Deputy Director, and leader of the GU Oncology Program at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine.

References

1. Hussain M, Tombal BF, Saad F, et al. Efficacy and safety of darolutamide (DARO) in combination with androgen-deprivation therapy (ADT) and docetaxel (DOC) by disease volume and disease risk in the phase 3 ARASENS study. Presented at: 2023 ASCO GU Cancers Symposium. February 16 – 182023. San Francisco, CA.

2. FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer. Published online August 5, 2022. Accessed August 5, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-darolutamide-tablets-metastatic-hormone-sensitive-prostate-cancer