Latest clinical trial results have reinforced the therapeutic value of NUBEQA® (darolutamide) across different patient populations with metastatic hormone-sensitive prostate cancer (mHSPC), marking a significant advancement in treatment options.
Compelling Results from ARANOTE Trial Subgroup Analysis
The ARANOTE trial, involving 669 patients, revealed striking efficacy differences across disease volume subgroups. In patients with low-volume disease, the combination of NUBEQA with androgen deprivation therapy (ADT) demonstrated a 70% reduction in the risk of radiological progression or death compared to placebo plus ADT (HR 0.30; 95% CI: 0.15-0.60). High-volume disease patients showed a 40% risk reduction (HR 0.60; 95% CI: 0.44-0.80), with median radiological progression-free survival extending to 30.2 months versus 19.2 months with placebo.
"At Bayer, our mission in prostate cancer care is centered on improving patient outcomes across all disease stages," said Christine Roth, Global Head of Product Strategy and Commercialization at Bayer's Pharmaceuticals Division. "The expanding body of evidence for NUBEQA highlights Bayer's commitment to supporting the diverse needs of prostate cancer patients."
Age-Related Benefits Confirmed in ARASENS Trial
Further strengthening NUBEQA's clinical profile, the ARASENS trial subgroup analysis of 1,305 patients demonstrated consistent benefits across age groups. Patients both under and over 75 years showed significant improvements in overall survival when treated with NUBEQA in combination with ADT and docetaxel. The younger cohort (<75 years) achieved a hazard ratio of 0.70 (95% CI 0.58-0.84), while the older group (≥75 years) showed a hazard ratio of 0.61 (95% CI 0.41-0.91).
Real-World Evidence Supports Clinical Findings
A retrospective cohort analysis provided compelling real-world evidence for NUBEQA's effectiveness. The study found that patients receiving NUBEQA combination therapy experienced:
- Lower treatment discontinuation rates (25% vs 38% at 18 months)
- Reduced progression to metastatic castration-resistant prostate cancer (24% vs 46% at 18 months)
- Higher PSA response rates (61.2% vs 46.6% achieving undetectable levels at 12 months)
Clinical Context and Disease Impact
Prostate cancer remains the second most common cancer in men globally, with particularly challenging outcomes for metastatic cases. Only 30% of patients diagnosed with mHSPC survive beyond five years, underscoring the critical need for effective treatment options.
The safety profile remained consistent with previous findings across all subgroups, with manageable treatment-emergent adverse events. These results provide clinicians with valuable insights for tailoring treatment approaches to individual patient characteristics, potentially improving outcomes across diverse patient populations.
