Not intended for U.S. and UK Media
Berlin, February 16, 2023 – New subgroup data from the Phase III ARASENS trial show overall survival (OS) benefits of darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with high and low-volume, as well as high and low-risk, metastatic hormone-sensitive prostate cancer (mHSPC), compared to ADT with docetaxel. The overall incidence of adverse events continues to be similar between treatment arms. The full results were presented at an oral presentation during the ASCO GU Congress 2023 and simultaneously published in the Journal of Clinical Oncology.1
“These latest findings from the ARASENS trial continue to reinforce the strong efficacy and favorable safety profile of darolutamide in mHSPC,” said Maha Hussain, M.D., Genevieve Teuton Professor of Medicine in the Division of Hematology Oncology, Department of Medicine, and the Deputy Director at the Robert H. Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, Chicago, USA. “The growing data from the ARASENS trial continue to demonstrate darolutamide’s value in treating patients with mHSPC. The benefit is especially in those with high-volume or high-risk disease. They also provide treating physicians with greater insight into the mHSPC patient population that may benefit from this therapy.”
“Despite recent advances, there still remains a need for treatments that extend survival and delay disease progression while maintaining quality of life. This latest subgroup analysis from the ARASENS trial highlights darolutamide’s potential to become a foundational therapy for patients with various types of metastatic disease burden,” said Tara Frenkl, M.D., Senior Vice President and Head of Oncology Development at Bayer. “An important part of our mission at Bayer is to transform prostate cancer care and improve patient outcomes at various stages of the disease. We are working to ensure that as many eligible patients as possible have the opportunity to benefit from darolutamide.”
In the ARASENS trial, patients were randomized 1:1 to receive darolutamide plus ADT in combination with docetaxel versus placebo plus ADT with docetaxel. High-volume disease was defined as visceral metastases and/or ≥4 bone metastases with ≥1 beyond the vertebral column/pelvis, as delineated in the CHAARTED criteria. High-risk disease was defined using the LATITUDE criteria, which includes ≥2 risk factors: a Gleason score of ≥8, ≥3 bone lesions, and the presence of measurable visceral metastasis. Of 1,305 patients in the full analysis set, 1,005 (77%) had high-volume disease, 912 (70%) had high-risk disease, 300 (23%) had low-volume disease, and 393 (30%) had low-risk disease.
The subgroup analysis showed that darolutamide plus ADT in combination with docetaxel prolonged OS in high-volume disease (hazard ratio [HR]=0.69; 95% CI: 0.57-0.82), compared to ADT with docetaxel. A consistent OS benefit was observed in both high-risk (HR=0.71; 95% CI; 0.58-0.86) and low-risk (HR=0.62; 95% CI: 0.42-0.90) disease. In the smaller group of patients with low-volume disease, the results are suggestive of a survival benefit with darolutamide (HR, 0.68; 95% CI, 0.41 to 1.13). Additionally, when compared to the ADT plus docetaxel arm, the darolutamide combination arm showed benefit for key clinically relevant secondary endpoints across all disease volume and disease risk subgroups. Incidences of treatment-related adverse events across subgroups were consistent with the overall ARASENS population.
Only 30% of those diagnosed with mHSPC will survive five years or more after diagnosis.2 Most people with mHSPC eventually progress to metastatic castration-resistant prostate cancer (mCRPC), a condition with limited long-term survival.3,4
The results of the subgroup analysis build on existing data from the ARASENS trial, as well as the overall population, which show that darolutamide plus ADT in combination with docetaxel significantly reduces the risk of death in patients with mHSPC by 32.5% (HR=0.68; 95% CI 0.57-0.80; P5