Bayer and Orion have reported positive results from a Phase III clinical trial (ARAMIS) of darolutamide in patients with non-metastatic castration-resistant prostate cancer.
Darolutamide is designed as a non-steroidal androgen receptor antagonist that binds to and inhibits the receptor function and growth of cancer cells. It is being jointly developed by Bayer and Finnish pharmaceutical company Orion.
Results showed that darolutamide in combination with androgen deprivation therapy (ADT) led to a significant extension in metastasis-free survival (MFS), demonstrating a median of 40.4 months compared to 18.4 months with placebo plus ADT.
Interim analysis of the combination therapy showed a positive trend in overall survival (OD) with a 29% decrease in risk of death.
The findings also revealed a favourable safety profile, with incidence of treatment-emergent adverse events being similar in both investigational and placebo arms.
Orion research and development senior vice-president Christer Nordstedt said: “Prostate cancer patients are still in need of treatments that are not only effective but also safe without adverse events that would compromise their quality of life.
“Orion is working hard to bring innovative treatments to cancer patients. With the positive results of ARAMIS trial, we together with Bayer are one step closer of bringing darolutamide to patients and their treating physicians.”
ARAMIS is a double-blind, placebo-controlled trial conducted to assess the safety and efficacy of 600mg darolutamide in a total of 1,509 patients already taking ADT and at high risk of developing metastatic disease.
The randomised, multi-centre trial’s primary endpoint is MFS, measured as the time between randomisation and evidence of metastasis or death.
Secondary endpoints of the trial are OS, time-to-pain progression, initiation of first cytotoxic chemotherapy, first SSE, and characterisation of the safety and tolerability of darolutamide.
The drug is also being evaluated in another Phase III trial called ARASENS, which involves patients suffering from metastatic hormone-sensitive prostate cancer.