On November 21, Bayer announced itsDaroheAmine（Product Name:Nubeqa）The supplemental New Drug Application (sNDA) for the combination of androgen deprivation therapy (ADT) in treating metastatic hormone-sensitive prostate cancer (mHSPC) patients has been accepted by the FDA.This sNDA is based on the positive results of the Phase III ARANOTE study. The study was a randomized, double-blind, placebo-controlled clinical trial (n=669) that evaluatedDaroheAmine (600mg, twice daily)Efficacy and Safety of Combined ADT vs. Placebo Combined with ADT in Patients with mHSPC.The primary endpoint of the study is radiographic progression-free survival (rPFS) at 36 months.The results showed that, compared with the placebo group,DaroheThe rPFS of the amine group was significantly prolonged (not reached vs 25.0 months, HR=0.54, P<0.0001), with a higher proportion of patients achieving 24-month rPFS (70.3% vs 52.1%), progressing toMetastatic Castration-Resistant Prostate Cancer (mCRPC) was significantly delayed (not reached vs 13.8 months, HR=0.40).DaroheAmine GroupThe proportion of patients in the placebo group achieving an overall survival (OS) of 24 months was similar (79.8% vs 75.5%).
DaroheDarolutamide is an oral androgen receptor inhibitor that was first approved for marketing in July 2019. To date, darolutamide has been approved for two indications, including ① monotherapy.Adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and ② in combination with docetaxel treatmentAdult patients with mHSPC.DaroheAmineOther phase III studies are ongoing, involving various stages of prostate cancer, including:ARASTEP Study: Aimed to EvaluateDaroheAmineEfficacy and Safety of Combined ADT vs ADT in High-Risk Biochemical Recurrence (BCR) and No Evidence of Metastatic Disease on Conventional Imaging with Positive PSMA PET/CT at Baseline in HSPC Patients.
DASL-HiCaP Study: Aimed atEvaluationDaroheAmine or placebo combined with ADT and radical radiotherapy or salvage radiotherapyEfficacy and Safety of Apalutamide in Patients with High-Risk Localized Prostate Cancer.
ERADICATE Study:Aims toEvaluationDaroheAmine or placebo combined with ADTTreatmentGao FengPatients with high-risk metastatic prostate cancerOfEfficacy and Safety。
PEACE 8 Study:Aiming toEvaluationDaroheAmineUnitedADTCompared with Stereotactic Body Radiation TherapyDaroheAmineUnitedADTSecond-line TreatmentmCRPC PatientsEfficacy and Safety。
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