Myovant Sciences has completed patient enrollment in its pivotal Phase 3 clinical trial, HERO evaluating the safety and efficacy of relugolix for the treatment of men with advanced prostate cancer. The HERO study is designed to support approval by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency.
"Completion of enrollment in HERO is a critical milestone for our prostate cancer program," said Lynn Seely, M.D., President and CEO of Myovant. "We look forward to reporting top-line efficacy and safety data for HERO in the fourth quarter of 2019. Relugolix is the only oral gonadotropin-releasing hormone, or GnRH, receptor antagonist in development to lower testosterone and prostate-specific antigen, or PSA, in men with prostate cancer."
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Pending positive Phase 3 results, Myovant expects to submit a New Drug Application for relugolix with the FDA in early 2020. If approved, relugolix has the potential to be the first oral GnRH receptor antagonist approved for the treatment of advanced prostate cancer. Relugolix is administered as one pill once-daily and has been shown to decrease testosterone and PSA levels within days in Phase 1 and 2 clinical studies.
This randomized, open-label, parallel-group, international Phase 3 clinical trial is evaluating 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. Patients enrolled in the study were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily or to treatment with leuprolide acetate 3-month depot injection, respectively. The primary efficacy outcome of the study is the ability of relugolix to achieve and maintain serum testosterone suppression to castrate levels (≤50 ng/dL [1.7 nmol/L]) for 48 weeks. A total of 934 patients have been enrolled in the HERO study in North and South America, Europe and the Asia-Pacific region.