Dr Carthon on Darolutamide Plus ADT in mHSPC

Bradley C. Carthon, MD, PhD, professor, Department of Hematology and Medical Oncology, section chief, Hematology and Oncology, Winship Cancer Institute, Emory University School of Medicine, discusses findings from the phase 3 ARANOTE trial (NCT04736199) which evaluated treatment with darolutamide (Nubeqa) and androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Results from ARANOTE were presented at the 2024 ESMO Congress and demonstrated a significant improvement in radiographic progression-free survival (rPFS) for patients treated with darolutamide plus ADT compared with ADT alone, Carthon begins. The study’s primary end point of rPFS was achieved, although data on overall survival (OS) is still maturing and will require additional follow-up, he explains.

The early data suggest that darolutamide may offer advantages over other androgen receptor inhibitors used in mHSPC, particularly with respect to adverse effects (AEs), Carthon continues. One of the key differentiators of darolutamide is its favorable AE profile, including a lower incidence of central nervous system–related toxicities, such as fatigue and cognitive dysfunction, which are often observed with other agents in this class. This could provide a more tolerable option for patients who need long-term treatment for mHSPC, he notes.

Carthon adds that while it is difficult to directly compare darolutamide with other agents due to the lack of head-to-head trials, the emerging data from both ARANOTE and retrospective studies suggest that darolutamide could play a significant role in the treatment landscape. The agent’s lower toxicity profile may allow patients to maintain a higher level of functioning, which is a critical factor in long-term disease management, he emphasizes.

The ongoing maturation of OS data will help clarify the long-term benefits of darolutamide, Carthon concludes. As more information becomes available, darolutamide has the potential to become a key therapeutic option in mHSPC, particularly for patients seeking a balance between efficacy and quality of life.