A phase 1/2 clinical trial investigating valemetostat (DS-3201b), a dual EZH1/2 inhibitor, combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) is going to start to recruit participants. This study aims to evaluate the safety, tolerability, and preliminary efficacy of the combination in men whose disease has progressed despite prior androgen receptor pathway inhibitors (ARPIs). […]
Gedatolisib, an inhibitor targeting the PI3K/AKT/mTOR pathway, in combination with darolutamide, an androgen receptor antagonist, is being evaluated as a treatment option for metastatic castration-resistant prostate cancer (mCRPC). In a phase 1/2 clinical trial, patients who had progressed on prior androgen receptor signaling inhibitors received once-weekly intravenous gedatolisib in doses of 120 mg or 180 […]
Recent data presented at the 2025 European Society for Medical Oncology (ESMO) Congress reveal a promising new treatment schedule for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The phase 3 ARASAFE trial evaluated an alternative docetaxel dosing regimen combined with darolutamide and androgen deprivation therapy (ADT), showing significant reductions in severe toxicities while maintaining effective […]
The European Commission has granted marketing authorization to darolutamide (Nubeqa) combined with androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC). This approval, following a positive opinion from the European Medicines Agency in June 2025, allows darolutamide plus ADT to be used with or without docetaxel, offering clinicians greater flexibility in tailoring treatment. […]
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