As recently published in the New England Journal of Medicine, relugolix demonstrated superior efficacy and a 54% lower risk of major adverse cardiovascular events compared to the current standard of care, leuprolide acetate injections, in the Phase 3 HERO study.
Myovant’s Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men 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.
Data from an additional key secondary endpoint, castration resistance-free survival, are expected in the third quarter of 2020.
In May 2020, Myovant submitted a separate NDA for once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with heavy menstrual bleeding associated with uterine fibroids. A Marketing Authorization Application for relugolix combination tablet in women with moderate to severe symptoms associated with uterine fibroids is also under review by the European Medicines Agency.