Myovant: Relugolix Phase 3 Study Meets Endpoints In Advanced Prostate Cancer

(RTTNews) - Myovant Sciences (MYOV) announced the Phase 3 HERO study of oral relugolix (120 mg) met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer. The results support a New Drug Application submission to the FDA in the second quarter of 2020.

In the primary endpoint responder analysis, 96.7 percent of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels. The pharmacodynamic results showed no testosterone flare after initiation of relugolix and mean testosterone levels returned to normal levels within 90 days after treatment discontinuation.

Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone production, the hormone primarily responsible for stimulating prostate cancer, and ovarian estradiol production.

Lynn Seely, CEO of Myovant Sciences, said: "We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer."

Shares of Myovant Sciences were up 53% in pre-market trade on Monday.