Phase III LIBERTY study of TAK 385 shows positive results for uterine fibroids.- Myovant Sciences

Myovant Sciences announced that the Phase III LIBERTY open-label extension study of once-daily, oral TAK 385 (relugolix combination therapy) - relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg - in women with uterine fibroids demonstrated an 87.7% response rate at one year while maintaining bone mineral density. Myovant expects to include the extension data in its New Drug Application (NDA) submission for heavy menstrual bleeding associated with uterine fibroids anticipated in April 2020. In the primary endpoint analysis, 87.7% of women achieved the responder criteria defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method. The one-year primary endpoint result in the LIBERTY open-label extension study demonstrated durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline at one year. Changes in bone mineral density through one year, as assessed by dual energy x-ray absorptiometry (DXA) every three months, were consistent with those in LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed. Adverse events reported in more than 10% of women treated with relugolix combination therapy for one year and more frequent than those reported in the placebo group after 6 months included only hot flash. There were no pregnancies reported in the relugolix combination therapy group. Complete results from the LIBERTY open-label extension study will be submitted for presentation at a future scientific meeting and publication in a medical journal.