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Pedro Barata, MD, discusses improved clinical outcomes with darolutamide in metastatic hormone-sensitive prostate cancer.
“There appear to be differences in the safety profiles, potentially favoring darolutamide to some extent compared with other androgen receptor inhibitors. The question [is] whether darolutamide offers a superior safety profile or better outcomes compared with other agents, such as apalutamide, enzalutamide, or abiraterone. [Although there] is no definitive answer at this time, longer follow-up data may clarify these differences and potentially demonstrate a survival advantage.”
Pedro Barata, MD, associate professor, medicine, Case Western Reserve University School of Medicine; medical oncologist, director, Clinical Genitourinary Medical Oncology Research Program, University Hospitals Seidman Cancer Center, Miggo Family Chair in Cancer Research, University Hospitals, discusses updated data from the phase 3 ARANOTE trial (NCT04736199) evaluating darolutamide (Nubeqa) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
ARANOTE assessed the efficacy and safety of darolutamide, an androgen receptor (AR) inhibitor, in combination with androgen deprivation therapy (ADT) compared with ADT alone. Conducted internationally, the trial excluded patients in the United States due to the routine use of AR inhibitors in this setting, Barata notes.
Updated data from the ARANOTE trial, presented at the 2024 ESMO Congress, demonstrated that adding darolutamide to ADT improved radiographic progression-free survival and other secondary efficacy end points in patients with mHSPC, reinforcing the importance of AR inhibitor–based therapies in this population. The findings build on prior data supporting the use of AR inhibitors, such as enzalutamide (Xtandi), apalutamide (Erleada), and abiraterone acetate (Zytiga), in combination regimens.
Barata emphasizes the importance of considering darolutamide’s safety profile during treatment, particularly its lower incidence of central nervous system–related adverse effects (AEs) compared with other androgen receptor inhibitors. No new safety signals with were observed with darolutamide plus ADT in ARANOTE. Common AEs included fatigue and musculoskeletal pain; these were consistent with prior studies of AR inhibitors.
The results from ARANOTE also highlight the need for continued research to refine treatment strategies in mHSPC. Barata notes that ongoing studies, such as the phase 2 ARASEC trial (NCT05059236), will provide additional insights into the role of darolutamide in this setting. Regulatory review of these data are anticipated, and may allow for the use of ADT plus darolutamide as a standard approach with or without docetaxel, he says.
Barata concludes that the ARANOTE trial underscores the evolving landscape of treatment for mHSPC and the critical role of AR inhibitors in improving patient outcomes. As longer follow-up data become available, the effect of darolutamide on survival and quality of life will be further clarified, shaping its integration into clinical practice, Barata concludes.
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