Myovant initiates Phase III HERO trial of relugolix to treat advanced prostate cancer-
Myovant Sciences announced it has initiated a Phase III clinical trial, HERO , to evaluate the safety and efficacy of relugolix in treating men with advanced prostate cancer. Relugolix is an oral, once-daily, small molecule, gonadotropin-releasing hormone (GnRH) receptor antagonist that lowers testosterone by inhibiting pituitary release of luteinizing hormone and follicle-stimulating hormone.
The HERO study is a randomized, open-label, parallel-group Phase III international clinical trial to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who require at least one year of continuous androgen deprivation therapy. Approximately 1,125 patients will be enrolled in this study in North and South America, Europe, and the Asia-Pacific region. Patients enrolled in the study will be randomized 2:1 to receive oral relugolix 120 mg once daily or leuprolide acetate 3-month depot injection, respectively. The primary efficacy outcome of the study will be the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels (less than 50 ng/dL [1.7 nmol/L]) for 48 weeks in patients with androgen-sensitive advanced prostate cancer.
Comment:Relugolix is an oral, once-daily drug whereas competitors are injectables.
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