Late-breaking data from the Phase III ARANOTE trial reveals that Nubeqa® (darolutamide) combined with androgen deprivation therapy (ADT) significantly improves radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The results were presented at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The Journal of Clinical Oncology.
The ARANOTE trial demonstrated a statistically significant and clinically meaningful improvement in rPFS with Nubeqa plus ADT compared to placebo plus ADT. The study met its primary endpoint, showing a 58% reduction in the risk of radiographic progression or death (HR 0.42; 95% CI, 0.34-0.52; P<0.0001).
Detailed Efficacy Findings
Key findings from the ARANOTE trial include:
- A significant improvement in median rPFS was observed in the Nubeqa plus ADT arm compared to the placebo plus ADT arm (not reached vs. 19.1 months).
- Subgroup analyses were consistent with the overall population, demonstrating benefit across various patient subgroups.
- The addition of Nubeqa to ADT delayed the time to initiation of cytotoxic chemotherapy.
"The magnitude of benefit from Nubeqa in combination with standard of care has the potential to change the treatment landscape for metastatic hormone-sensitive prostate cancer, which continues to be an area of unmet need," said Fred Saad, MD, FRCS, a leading investigator in the ARANOTE trial.
Safety and Tolerability
The safety profile of Nubeqa plus ADT was generally consistent with previous studies. Overall adverse events (AEs) were similar between the Nubeqa and placebo arms. Serious AEs occurred in 24.1% of patients receiving Nubeqa plus ADT and 24.8% of patients receiving placebo plus ADT.
About the ARANOTE Trial
The ARANOTE trial (NCT04735162) is a randomized, double-blind, placebo-controlled, multi-center Phase III study evaluating the efficacy and safety of Nubeqa plus ADT versus placebo plus ADT in patients with mHSPC. A total of 1,305 patients were randomized 1:1 to receive either Nubeqa 600 mg twice daily or placebo, both in combination with ADT.
The primary endpoint of the trial was rPFS, defined as the time from randomization to first evidence of radiographic progression or death from any cause. Secondary endpoints included overall survival (OS), time to castration resistance (TTCR), time to initiation of cytotoxic chemotherapy, and safety.
About Metastatic Hormone-Sensitive Prostate Cancer
Metastatic hormone-sensitive prostate cancer (mHSPC) refers to prostate cancer that has spread to distant sites in the body and still responds to androgen deprivation therapy (ADT). Despite initial responses to ADT, most patients eventually develop castration-resistant prostate cancer (CRPC).
Prostate cancer is a leading cause of cancer-related deaths in men worldwide. In 2020, there were an estimated 1.4 million new cases and 375,000 deaths globally. Improving outcomes for patients with mHSPC remains a critical area of unmet medical need.
About Nubeqa® (darolutamide)
Nubeqa® (darolutamide) is an androgen receptor inhibitor (ARI) indicated for the treatment of mHSPC. It is designed to block the androgen receptor, thereby inhibiting the growth of prostate cancer cells.
In addition to the ARANOTE trial, darolutamide is being evaluated in a comprehensive development program, including the Phase III ARASENS trial in mHSPC and the Phase III ODENZA trial in non-metastatic castration-resistant prostate cancer (nmCRPC). Data from these trials have supported regulatory approvals globally.
Bayer’s Commitment to Oncology
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative cancer treatments. The company focuses its research and development efforts on addressing unmet medical needs in oncology, with the goal of improving outcomes for patients worldwide.
About Orion Corporation
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients.
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