The oral androgen receptor inhibitor (ARi) darolutamide already received approval in China to treat non-metastatic castration-resistant prostate cancer (nmCRPC) patients at high risk of developing metastatic disease.
The NMPA granted the approval based on the positive results obtained from the Phase III ARASENS clinical trial of darolutamide.
In this randomised, multi-centre, double-blind, placebo-controlled trial, darolutamide and androgen deprivation therapy (ADT) along with docetaxel demonstrated significant reduction in death risk by 32.5% against ADT with docetaxel, in patients with mHSPC.
The darolutamide combination also showed consistent benefits across clinically relevant secondary endpoints.
The overall incidence of treatment-emergent adverse events in the trial were found to be similar between treatment arms.
Darolutamide is developed by Orion and Bayer jointly.
In the ARASENS trial, a total of 1,306 newly diagnosed patients were randomised in a 1:1 ratio to receive 600mg of darolutamide two times a day or matching placebo, plus ADT and docetaxel.
Overall survival (OS) was the primary endpoint of the trial and secondary endpoints included time to pain progression, time to castration-resistant prostate cancer (CRPC), time to first symptomatic skeletal event (SSE), time to initiation of subsequent anticancer therapy, all measured at intervals of 12 weeks.
Secondary endpoints also included adverse events (AEs).
Darolutamide has a distinct chemical structure that attaches to the receptor with high affinity and demonstrates strong antagonistic activity, thereby inhibiting the receptor function and prostate cancer cells growth.