Myovant Sciences presents additional data on relugolix combination therapy from phase III LIBERTY studies in women with uterine fibroids and from ovulation inhibition study.

Myovant Sciences announced the presentation of additional data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids . The data were presented in virtual oral and poster sessions during the European Society of Human Reproduction and Embryology (ESHRE) virtual 36th Annual Meeting.

Details of the presentations are as follows : Relugolix combination therapy reduced patient-reported distress from bleeding and pelvic symptoms and improved daily activities in patients with uterine fibroids in the LIBERTY program (oral presentation, O-024) In the Phase III LIBERTY program, women were asked to provide feedback (between 0 and 100) on the Bleeding and Pelvic Discomfort (BPD) scale, which assesses distress due to heavy menstrual bleeding, passing blot clots, and pelvic pressure/tightness, and the Revised Activities (RA) scale (between 0 and 100), which assesses physical and social activities. Reductions in distress on the BPD scale from baseline to Week 24 were significantly greater for women taking relugolix combination therapy (48.4 point reduction) than placebo (17.4 point reduction) (p < 0.0001).Improvements in physical and social activities on the RA scale from baseline to Week 24 were significantly greater for women taking relugolix combination therapy (45.1 point increase) than placebo (15.8 point increase) (p < 0.0001). Responder rates (women reporting at least a 20-point change from baseline to Week 24) were significantly higher for women taking relugolix combination therapy (62.5% on BPD, 61.7% on RA) than placebo (28.1% on BPD, 34.0% on RA) (all p < 0.0001). Relugolix combination therapy improves hemoglobin levels in anemic women with heavy menstrual bleeding due to uterine fibroids: results from the LIBERTY Phase 3 program (oral presentation, O-023).

In the Phase III LIBERTY program, approximately one-third of women had anemia (hemoglobin less than 10.5 g/dL) at baseline. These women were more likely to be Black/African American (65.2% versus 51.2% in overall study population) and their baseline menstrual blood volume was higher (mean: 285.5 mL versus 228.8 mL in overall study population), where menstrual blood volume > 80 mL in a cycle is defined as heavy menstrual bleeding. The percentage of women with a clinically-meaningful increase in hemoglobin levels ( less than 2 g/dL) from baseline to Week 24 was higher for women taking relugolix combination therapy (55.7%) than placebo (11.7%) (p < 0.0001). The mean percentage increase in hemoglobin concentration from baseline to Week 24 was significantly greater in women taking relugolix combination therapy (23.0%) than placebo (6.4%) (p < 0.0001). Suppression of ovarian activity during co-administration of the oral gonadotropin-releasing hormone receptor antagonist relugolix, estradiol, and norethindrone acetate in healthy female volunteers (poster presentation, P-287).

In a Phase 1 open-label, single-arm ovulation inhibition study , 67 healthy premenopausal women were evaluated over an 84-day treatment period (three cycles) to assess the effects of relugolix combination therapy on ovulation inhibition, per the Hoogland-Skouby assessment scale (score < 5). A post-treatment follow-up period assessed time to the return of ovulation. Once-daily dosing with relugolix combination therapy resulted in suppression of ovarian activity and inhibition of ovulation in 100% of women during the treatment period. Mean and median estradiol levels were between 30 and 44 pg/mL during treatment. Ovarian activity resumed after treatment discontinuation, with ovulation occurring a mean of 23.5 days after the last treatment day. Relugolix combination therapy was generally well-tolerated.