ASCO GU 2019 Press Releases
ASCO GU 2019 Press Releases
ASCO GU 2019: Phase 3 Study of Androgen Deprivation Therapy with Enzalutamide or Placebo in Metastatic Hormone-Sensitive Prostate Cancer: The ARCHES Trial
First in 2012, AFFIRM showed in a population of post-chemotherapy mCRPC patients that enzalutamide improved overall survival compared with placebo (18.4 months vs 13.6 months, HR 0.63, p<0.001), which led to its first FDA approval in prostate cancer.2 Next in 2014, PREVAIL showed that enzalutamide was able to decrease the risk of radiographic progression and death and delay chemotherapy which broadened its FDA approval to all patients with mCRPC.3 Most recently, based on the results of PROSPER which showed that enzalutamide significantly reduced the risk of developing M1 CRPC by prolonging metastasis-free survival (36.6 vs 14.7 months), enzalutamide gained an FDA indication in 2018 for use in men with non-metastatic CRPC with a PSA doubling time of less than 10 months.4 This study aims to provide evidence for the only space left untouched by enzalutamide – metastatic castration sensitive prostate cancer.
MDxHealth Announces Presentation of Positive Data for SelectMDx and ConfirmMDx in Prostate Cancer Diagnosis
ARAMIS: Efficacy and Safety of Darolutamide in nmCRPC | ASCO GU 2019
Breaking News: Darolutamide Receives FDA Approval for the Treatment of Non-metastatic Castration-resistant Prostate Cancer
San Francisco, CA (UroToday.com) The use of androgen-axis targeted agents, specifically enzalutamide and abiraterone, have drastically changed the landscape of advanced prostate cancer management. Just last year, at GU ASCO 2018, two landmark trials were presented – SPARTAN and PROSPER - which were conducted in nonmetastatic CRPC (nmCRPC) patients.1,2 PROSPER specifically assesses enzalutamide in the M0 CRPC setting, while SPARTAN focused on apalutamide-ARN-509 (APA). Apalutamide is a next-generation competitive inhibitor of the androgen receptor under development for the treatment of patients with prostate cancer but perhaps with greater potency and reduced CNS effects. Both demonstrated ~2 year metastases-free survival benefit compared to ADT alone and there was early evidence of OS benefit.