Dr Saad on the Safety Profile of Darolutamide Plus ADT in mHSPC

Fred Saad, CQ, MD, FRCS, FCAHS, director, Prostate Cancer Research, Montreal Cancer Institute, Centre Hospitalier de l’Université de Montréal; full professor, Department of Surgery, Université de Montréal; uro-oncologist, Urology Department, University of Montreal Health Center, discusses safety findings from the phase 3 ARANOTE trial (NCT04736199) investigating darolutamide (Nubeqa) plus androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Currently available treatment regimens for patients with mHSPC that include adding therapies to ADT are associated with significant adverse effects (AEs), Saad begins. Accordingly, safety outcomes from the ARANOTE trial were crucial to report, he says. Both the the phase 3 ARASENS trial (NCT02799602) investigating darolutamide plus ADT and docetaxel in patients with mHSPC, as well as the phase 3 ARAMIS trial (NCT02200614), which evaluated darolutamide plus ADT in patients with nonmetastatic castration-resistant prostate cancer, demonstrated the tolerable safety profile of darolutamide in patients with prostate cancer, he says.

The safety data from ARANOTE are consistent with that of prior trials evaluating darolutamide, Saad explains. In ARANOTE, the safety profile of darolutamide plus ADT was similar to that of placebo plus ADT, which was encouraging, he notes.

Furthermore, fewer patients discontinued darolutamide vs placebo because of AEs, he reports. Additionally, the rates of fatigue were lower in patients in the darolutamide vs placebo arms, he states. Saad concludes by saying that he was encouraged to see similar safety profiles between darolutamide plus ADT and placebo plus ADT.

Disclosures: Dr Saad reports holding consulting or advisory roles with AbbVie, Advanced Accelerator Applications, Astellas, AstraZeneca/MedImmune, Bayer, Janssen, Knight, Myovant, Novartis, Pfizer, and Sanofi; receiving honoraria from AbbVie, Advanced Accelerator Applications, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Knight, Merck, Myovant, Novartis, Pfizer, and Sanofi; and receiving institutional research funding from Advanced Accelerator Applications, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Merck, Novartis, Pfizer, and Sanofi.