ESMO 2024: Positive results for darolutamide plus ADT in patients with mHSPC

16 September 2024

German pharma major Bayer (BAYN: DE) today released results from the Phase III ARANOTE trial at the European Society for Medical Oncology (ESMO) taking place in Spain.

The Phase III study demonstrated that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Consistent benefits in rPFS were observed across pre-specified subgroups, including patients with high- and low-volume mHSPC. Treatment emergent adverse event (TEAEs) were low and similar between treatment groups.

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