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NCODA Oncology and Hematology Meeting Abstracts | Volume 1 | Supplement 1
Publication Date: June 15, 2026

Efficacy and safety of darolutamide plus androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer from the phase 3 ARANOTE trial

Authors:

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, FAPO1,2, on behalf of Fred Saad, MD3; Egils Vjaters, MD4; Neal Shore, MD, FACS5; David Olmos, MD, PhD6; Nianzeng Xing, MD7; Andrea Juliana P. de Santana Gomes, MD8; Augusto Cesar de Andrade Mota, MD, PhD9; Pamela Salman, MD, PhD10; Mindaugas Jievaltas, MD, PhD11; Maris Jakubovskis, MD, PhD12; Albertas Ulys, MD, PhD13; Evgeny Kopyltsov, MD, PhD14; Weiqing Han, MD, PhD15; Isabella Testa, MD16; Marie Aude Le Berre, MSc17; Iris Kuss, MD18; Liina Nevalaita, MD19; Kunhi Parambath Haresh, MD20

Organization / Company:

1Minnesota Oncology, St. Paul, Minnesota, USA; 2Mayo Clinic College of Medicine, Rochester, Minnesota, USA; 3Department of Surgery/Urology, Centre Hospitalier de l’Université de Montréal, University of Montreal, Montreal, Quebec, Canada; 4P. Stradinš Clinical University Hospital, Riga, Latvia; 5Carolina Urologic Research Center and AUC Urology Specialists, Myrtle Beach, South Carolina, USA; 6Department of Medical Oncology, Hospital Universitario 12 de Octubre, Instituto de Investigación Sanitaria Hospital 12 de Octubre (Imas12), Madrid, Spain; 7Department of Urology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; 8Liga Norte Riograndense Contra O Cancer, Natal, Brazil; 9Medical Oncology, Instituto ETICA – Clinica AMO/DASA, Salvador, Brazil; 10Oncovida Research, Santiago, Chile; 11Lithuanian University of Health Sciences, Medical Academy, Kaunas, Lithuania; 12Clinic of Urology and Oncological Urology, Riga East University Hospital, Riga, Latvia; 13National Cancer Institute, Vilnius University, Vilnius, Lithuania; 14Clinical Oncological Dispensary of Omsk Region, Omsk, Russian Federation; 15Department of Urology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Center, Changsha, Hunan, China; 16Bayer S.p.A, Milan, Italy; 17Bayer Healthcare SAS, Lille, France; 18Bayer AG, Berlin, Germany; 19Orion Corporation, Orion Pharma, Espoo, Finland; 20All India Institute of Medical Sciences, New Delhi, India

NCODA Oncol Hematol Meet Abstr. 2026;1(suppl 1):abstr 10.
https://doi.org/10.67209/TFDJ1461
Background:

In ARASENS, darolutamide + androgendeprivation (ADT) + docetaxel significantly improved overall survival vs ADT + docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC), and incidences of treatment-emergent adverse events (TEAEs) were similar in both groups. The phase 3 global ARANOTE trial2 (NCT04736199) compared darolutamide + ADT versus (vs) ADT in patients with mHSPC. The primary results are reported. Eligible patients had mHSPC by conventional imaging, Eastern Cooperative Oncology Group (ECOG) performance status of 0–2, and started ADT ≤12 weeks. Patients were randomized 2:1 to darolutamide 600 mg twice daily or placebo, each with ADT. The primary endpoint was radiological progression-free survival (rPFS). Secondary endpoints included overall survival, time to initiation of subsequent anticancer therapy, time to castration-resistant prostate cancer (CRPC), time to prostate-specific antigen (PSA) progression, time to pain progression, and safety.

 

Objectives:
  • Describe the primary efficacy and safety results of darolutamide plus ADT in patients with mHSPC, in the phase 3 ARANOTE trial.

 

Methods:

A total of 669 patients were randomized (darolutamide, N=446; placebo, N=223); median age was 70 years; 31% were Asian, 9.7% were Black, median PSA at baseline was 21.3 ng/mL, and 71% had high-volume mHSPC. At primary data cutoff (June 7, 2024), darolutamide + ADT significantly improved radiographic progression-free survival (rPFS), reducing risk of radiologic progression or death by 46% versus (vs) placebo + ADT (hazard ratio [HR] 0.54; 95% confidence interval [CI] 0.41–0.71; P<0.0001) with consistent benefits observed across prespecified subgroups, including in high- and low-volume metastatic hormone-sensitive prostate cancer (mHSPC), with risk reductions of 40% and 70% (HR 0.60; 95% CI 0.44–0.80 and HR 0.30; 95% CI 0.15–0.60).

 

Results:

Darolutamide was associated with a positive trend for overall survival (HR 0.81; 95% CI 0.59–1.12) and clinical benefits across all secondary efficacy endpoints, including time to CRPC (HR 0.40; 95% CI 0.32–0.51), time to PSA progression (HR 0.31; 95% CI 0.23–0.41), time to subsequent therapy (HR 0.40; 95% CI 0.29–0.56), and time to pain progression (HR 0.72; 95% CI 0.54–0.96). Incidences of TEAEs were low and similar between groups, and treatment discontinuations due to TEAEs were lower in patients receiving darolutamide vs placebo (6.1% vs 9.0%).

 

Conclusions:

ARANOTE confirms the strong efficacy and favorable tolerability of darolutamide in mHSPC. ARASENS and ARANOTE demonstrate the benefit of darolutamide with and without chemotherapy, providing the option to tailor treatment, and allowing patients to live longer without progression and with minimal treatment burden.

Funding: Bayer AG.

 

Prior Presentations:

Presented at the European Society for Medical Oncology (ESMO) Annual Congress 2024, September 13-17, Barcelona, Spain.

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