Bayer AG has announced promising results from its Phase 3 ARANOTE trial for darolutamide, a drug that targets the growth of prostate cancer cells. The trial demonstrated that darolutamide, when combined with androgen deprivation therapy (ADT), significantly reduced the risk of disease progression or death by 46% compared to placebo plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC). This positive data, presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology, adds to the growing body of evidence supporting darolutamide’s effectiveness in treating prostate cancer.
This news is particularly significant as darolutamide is already approved for mHSPC under the brand name Nubeqa in combination with ADT and docetaxel. The drug, co-developed by Bayer and Orion Corporation, has also been approved for non-metastatic castration-resistant prostate cancer (nmCRPC) in high-risk patients. The ARANOTE trial provides further evidence for its potential in a broader range of patients.
The trial showed consistent benefits in radiological progression-free survival (rPFS) across patient subgroups, including those with high- and low-volume mHSPC, with a risk reduction of 40% and 70% respectively. While the overall survival (OS) data is still immature, preliminary analysis suggests a potential benefit with darolutamide plus ADT compared to placebo plus ADT. Additionally, the ARANOTE data indicated numerical clinical benefits across other secondary endpoints, including delaying the time to castration-resistant prostate cancer (CRPC), PSA progression, pain progression, and initiation of subsequent systemic therapy compared to placebo plus ADT.
The incidence of treatment-emergent adverse events (TEAEs) was low, with most being grade 1 or 2, and similar between treatment arms. Treatment discontinuations due to TEAEs were lower in patients receiving darolutamide compared to placebo plus ADT (6.1% vs 9.0%).
These findings highlight the potential of darolutamide as a valuable treatment option for patients with mHSPC. Bayer plans to submit the data from the ARANOTE trial to health authorities globally to support the expanded use of darolutamide in this patient population.
The significance of this research is underscored by the global burden of prostate cancer. Prostate cancer is the second most common cancer in men worldwide and the fifth most common cause of cancer death. Prostate cancer diagnoses are projected to increase from 1.4 million annually in 2020 to 2.9 million by 2040, making research into effective treatments like darolutamide crucial for improving patient outcomes.
