Darolutamide/ADT Combo Delays Disease Worsening in Some PC, Phase 3 Trial Shows

Darolutamide/ADT Combo Delays Disease Worsening in Some PC, Phase 3 Trial Shows
Darolutamide in combination with androgen deprivation therapy (ADT) delays disease worsening in men with non-metastatic castration-resistant prostate cancer (nmCRPC) and stabilizes their quality of life without increasing the incidence of adverse events, new data from a Phase 3 trial shows. The findings were presented in an oral presentation titled, "Impact of darolutamide (DARO) on pain and quality of life (QoL) in patients (Pts) with nonmetastatic castrate-resistant prostate cancer (nmCRPC)," at the recent 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Darolutamide, also known as ODM-201 or BAY-1841788, is an investigational prostate cancer therapy being developed by Bayer and Orion. It is an androgen receptor antagonist that binds to the receptor, interrupting the androgen signaling cascade and preventing cancer cells from receiving growth signals. The safety and efficacy of darolutamide among patients with nmCRPC is being tested in a multi-center, randomized, double-blind, placebo-controlled, Phase 3 trial (NCT02200614), called ARAMIS. The study enrolled 1,509 patients who were randomly assigned to receive either darolutamide or a placebo, twice a day, while they continued treatment with ADT. The first results from the trial were recently presented at the 2019 Genitourinary Cancers Symposium in San Francisco, and published in the New England Journal of Medicine in a study titled, "Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer." According to ARAMIS topline data, darolutamide prolonged the time patients lived without cancer spreading to other tissues and organs from 18.4 months to 40.4 months, which corresponds to a reduction of 59% in the risk of cancer spread or death. In addition, darolutamide ex
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