Myovant Sciences’ (NASDAQ:MYOV) oral gonadotropin-releasing hormone receptor antagonist, relugolix, met its primary efficacy endpoint in a Phase 3 trial of men with advanced prostate cancer.
In the HERO study, nearly 97% of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels. Five key secondary endpoints demonstrated superiority to leuprolide acetate, including the suppression of testosterone, prostate-specific antigen and follicle-stimulating hormone.
“An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years,” Dr. Neal Shore, medical director of the Carolina Urologic Research Center and HERO program steering committee member, said in a statement.
“If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer,” he added.
Myovant plans to submit an NDA to the FDA in the second quarter of 2020.
