Myovant Sciences presents additional data on bone mineral density in women with uterine fibroids from phase III LIBERTY program of relugolix combination therapy.

Myovant Sciences announced the presentation of one-year data on bone mineral density (BMD) from the Phase III LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. The findings were presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, held September 11-15, 2020. “Uterine fibroids are a chronic condition, but the duration of use for existing treatment options has been limited by concerns about potential bone loss while on therapy,” said Michael McClung, M.D., founding director of the Oregon Osteoporosis Center. “These new data show relugolix combination therapy maintained bone mineral density over one year of treatment, consistent with that of untreated, age-matched women with uterine fibroids in a concurrent study.” Details of the presentations are as follows :1."Relugolix Combination Therapy Preserves Bone Mass in Patients with Uterine Fibroids: Results from Phase III LIBERTY Program" (Abstract # P-641):The Phase III LIBERTY program evaluated the safety and efficacy of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding due to uterine fibroids. The program met its primary endpoints and demonstrated that relugolix combination therapy significantly reduced menstrual blood loss and pain. In this analysis, pooled data from 768 women in the LIBERTY 1 and LIBERTY 2 studies showed that mean changes in lumbar spine bone mineral density (LS BMD) were comparable for relugolix combination therapy and placebo (Week 12: -0.63% vs. 0.34%; Week 24: -0.23% vs. 0.18%, respectively). 2."Evaluation of Relugolix Combination Therapy to Maintain Bone Mass in Women with Uterine Fibroids Through 52 Weeks: LIBERTY Long-Term Extension Study. (Abstract # P-639). : Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period, for a total treatment period of up to 52 weeks. In this analysis, data from 163 women who entered the extension study after receiving 24 weeks of relugolix combination therapy demonstrated maintenance of BMD through 52 weeks of treatment (Week 52: LS BMD -0.80%). 3."A Prospective Observational Study of Bone Mineral Density in Premenopausal Women with Uterine Fibroids" (Abstract # P-552) : This prospective observational study was designed to characterize longitudinal BMD in 262 premenopausal women with uterine fibroids. Mean LS BMD showed minimal changes over the 52-week observational period (0% at Week 24 and -0.41% at Week 52). Relugolix combination tablet is under review by the FDA for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. Myovant has also reported positive data from two replicate Phase III studies evaluating relugolix combination therapy in women with endometriosis.