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Abstract
Androgen deprivation therapy is the standard of care for patients with advanced hormone-sensitive prostate cancer. Despite an initial response, most patients progress to castration-resistant prostate cancer (CRPC). The realization that CRPC remains driven by androgen receptor (AR) signaling has formed the basis for a new generation of agents targeting the AR axis. Two of these agents, abiraterone acetate and enzalutamide, have been shown to prolong overall survival in patients with CRPC. Several other AR inhibitors are currently in development for the treatment of CRPC. The present article reviews ODM-201, a new-generation AR inhibitor with a unique molecular structure, in the treatment of CRPC. The design of an ongoing Phase III trial (ARAMIS) of ODM-201 in men with non-metastatic CRPC is also discussed, at a disease stage for which there is currently no approved treatment.
Financial & competing interests disclosure
K Fizazi has participated in advisory boards for Orion Pharma. Writing and editorial assistance was provided by Harriet Lamb of Bioscript Medical, which was funded by Orion Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
ODM-201 is a next-generation androgen receptor (AR) inhibitor with strong affinity for the AR receptor.
ODM-201 suppresses AR mutants known to confer resistance to second-generation anti-androgens.
Brain penetration of ODM-201 is found to be negligible in preclinical studies.
ODM-201 has promising anti-tumor activity in chemotherapy-naïve and chemotherapy-pretreated men with metastatic castration-resistant prostate cancer.
ODM-201 has a favorable tolerability profile, with no seizures reported to date.
A placebo-controlled, randomized Phase III trial of ODM-201 in men with non-metastatic castration-resistant prostate cancer is underway.