Data presented at the ESMO Asia Congress 2023 demonstrates that darolutamide (Nubeqa) in combination with androgen deprivation therapy (ADT) and docetaxel significantly improves overall survival (OS) in Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC). The findings are based on a subgroup analysis of the ARASENS trial, which evaluated the efficacy and safety of darolutamide in this patient population.
The ARASENS trial randomized patients to receive either darolutamide 600 mg twice daily or placebo, in addition to ADT and docetaxel. The primary endpoint was overall survival. Key secondary endpoints included time to castration-resistant prostate cancer (CRPC) and time to prostate-specific antigen (PSA) progression.
Key Findings in Chinese Patients
The subgroup analysis included 202 patients from mainland China (104 receiving darolutamide and 98 receiving placebo). The results showed that darolutamide reduced the risk of death by 36.4% compared to placebo (HR 0.64, 95% CI 0.41–0.99). This survival benefit was observed despite a high proportion of patients in the placebo group receiving subsequent life-prolonging therapy (73.5% vs 59.2% in the darolutamide group).
Darolutamide also significantly delayed time to CRPC (HR 0.32, 95% CI 0.20–0.50) and time to PSA progression (HR 0.22, 95% CI 0.13–0.37). Furthermore, a significantly higher proportion of patients in the darolutamide group achieved undetectable PSA levels (<0.2 ng/mL) at any time compared to the placebo group (71.2% vs 19.4%).
The median treatment duration was longer with darolutamide compared to placebo (41.1 vs 16.6 months). The incidence of treatment-emergent adverse events (TEAEs) was comparable between the two groups. Neutropenia, a known toxicity of docetaxel, was the most common grade 3/4 TEAE.
Clinical Implications
These findings support the use of darolutamide in combination with ADT and docetaxel for the treatment of Chinese patients with mHSPC. The results are consistent with the overall ARASENS population, reinforcing the global benefit of this treatment regimen.
The study authors concluded that darolutamide offers a significant improvement in overall survival and delays disease progression in this patient population, with a manageable safety profile.
