Darolutamide plus androgen deprivation therapy significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer
September 16, 2024 – Clinical Trials, Drug Discovery, Pharmaceutical – Bayer, ESMO 2024, Orion, Prostate cancer, androgen deprivation therapy, oncology
- Results from the pivotal Phase III ARANOTE trial evaluating darolutamide plus androgen deprivation therapy (ADT) showed a statistically significant increase in radiological progression-free survival (rPFS) compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer
- Darolutamide plus ADT now has positive data both with and without docetaxel based on two pivotal Phase III studies in metastatic hormone-sensitive prostate cancer
- Safety analysis reconfirms the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials
- Data from ARANOTE trial presented as a late-breaking oral presentation at the ESMO 2024 Congress and simultaneously published in The Journal of Clinical Oncology.
16 September 2024 — Helsinki, Finland — Results from the Phase III ARANOTE trial have shown that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Consistent benefits in rPFS were observed across prespecified subgroups, including patients with high- and low-volume mHSPC. Treatment emergent adverse event (TEAEs) were low and similar between treatment groups. The results were presented at the 2024 ESMO Congress and have been simultaneously published in The Journal of Clinical Oncology.
“Darolutamide, a compound originated by Orion R&D, continues to deliver clinical benefit in patients with metastatic hormone-sensitive prostate cancer, now in ARANOTE with ADT alone and earlier in ARASENS in combination with ADT and docetaxel. These results also reflect our fruitful collaboration with Bayer for more than ten years with a focus to deliver new personalised treatment options to the patients with prostate cancer,” said Professor, M.D., Ph.D. Outi Vaarala, Senior Vice President of Innovative Medicines and Research & Development at Orion.
Bayer plans to submit the data from the ARANOTE trial to health authorities globally to support the expanded use of darolutamide in patients with mHSPC. Darolutamide is already approved for the treatment of patients with mHSPC under the brand name Nubeqa® in combination with ADT and docetaxel in more than 80 markets, and for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease, in over 85 countries around the world. The product is developed jointly by Orion and Bayer.
About Orion
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion’s net sales in 2023 amounted to EUR 1,190 million and the company had about 3,600 employees at the end of the year. Orion’s A and B shares are listed on Nasdaq Helsinki. Visit: www.orion.fi/en.
