Dr. Tombal on the OS Benefit of Darolutamide Plus ADT/Docetaxel in mHSPC

Bertrand Tombal, MD, PhD, professor of Physiology, chair of the Division of Urology, the Université catholique de Louvain, the Cliniques universitaires Saint-Luc, in Brussels, Belgium, discusses the overall survival (OS) benefit associated with androgen-deprivation therapy plus darolutamide (Nubeqa) in metastatic hormone-sensitive prostate cancer (mHSPC).

The phase 3 ARASENS trial (NCT02799602) evaluated the efficacy and safety of the triplet vs ADT and docetaxel alone in patients with mHSPC. Previously reported data from the study showed that the addition of darolutamide to ADT and docetaxel reduced the risk of death by 32.5% (HR, 0.68; 95% CI, 0.57-0.80; P < .0001).

In updated data presented at the 2023 Genitourinary Cancers Symposium, investigators reported OS data observed in subgroups of patients by disease volume and disease risk. Findings showed that darolutamide plus ADT/docetaxel reduced the risk of death by about 30% across all volume and risk subgroups. The median OS was not reached (NR) for those with high-volume disease (HR, 0.69; 95% CI, 0.57-0.82) or low-volume disease (HR, 0.68; 95% CI, 0.41-1.13). The median OS was also not NR in both the high-risk disease subgroup (HR, 0.71; 95% CI, 0.58-0.86) and the low-risk disease subgroup (HR, 0.62; 95% CI, 0.42-0.90).

These data led investigators to conclude that darolutamide plus ADT/docetaxel should be considered a new standard of care for patients with mHSPC.

Although the addition of darolutamide significantly increased OS in the overall population, investigators aimed to identify if that benefit was consistent across the volume and risk subgroups, Tombal says. As expected, less death and progression were observed in patients with low-risk or low-volume disease; however, the benefit of darolutamide remained consistent across each subgroup, Tombal adds.

These data reassure the assessment that if a physician believes that a patient needs treatment with ADT plus docetaxel, they will benefit from the addition of darolutamide, irrespective of disease volume or risk, Tombal concludes.