Bayer AG announced positive results from the Phase 3 ARANOTE trial, revealing that darolutamide combined with androgen deprivation therapy (ADT) significantly decreased the risk of radiological progression or death by 46% (HR 0.54) in patients diagnosed with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT. These findings, presented at the 2024 ESMO Congress and published in The Journal of Clinical Oncology, pave the way for a potential expanded use of darolutamide in mHSPC treatment.
ARANOTE Trial Results
The ARANOTE trial demonstrated that darolutamide plus ADT exhibited 'positive data' both with and without docetaxel. Consistent benefits in radiological progression-free survival (rPFS) were observed across patient subgroups, including high- and low-volume mHSPC, with risk reductions of 40% and 70%, respectively. An analysis of immature data for overall survival (OS) suggested a potential benefit with darolutamide plus ADT compared to placebo plus ADT.
The ARANOTE data also indicated numerical clinical benefits across all 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. Incidences of treatment-emergent adverse events (TEAEs) were low, mostly 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%).
Current Approvals and Market Performance
Darolutamide is currently approved for mHSPC, marketed under the brand name Nubeqa, in combination with ADT and docetaxel, and for non-metastatic castration-resistant prostate cancer (nmCRPC) patients at high risk of developing metastatic disease. Developed jointly by Bayer and Orion Corporation, Nubeqa generated sales of 380 million euros in the second quarter of 2024, marking an 89% year-over-year increase.
Prostate Cancer Burden
Prostate cancer remains a significant global health concern, being the second most common cancer in men and the fifth leading cause of cancer death in men worldwide. Diagnoses are projected to increase from 1.4 million annually in 2020 to 2.9 million by 2040, underscoring the need for more effective treatment options.
