Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Studies in Endometriosis and Uterine Fibroids - Seite 2

Details of the presentations from studies of women with uterine fibroids are as follows:

The Phase 3 LIBERTY program evaluated the efficacy and safety of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding associated with uterine fibroids in two replicate studies, LIBERTY 1 and 2. The primary endpoint of both studies was met with a significant proportion of women treated with relugolix combination therapy achieving the responder criteria for reduction in menstrual blood loss compared with placebo after 24 weeks of treatment (p < 0.0001 in both studies). Eligible women who completed the 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 52 weeks.

• LIBERTY: Long-Term Extension Study Demonstrating One-Year Efficacy and Safety of Relugolix Combination Therapy in Women with Symptomatic Uterine Fibroids (oral presentation, O-1, Scientific Congress Prize Paper Session 1)
  In this first presentation of detailed data from the LIBERTY long-term extension study, 87.7% of women achieved the responder criteria for reduction in menstrual blood loss at one year. Women experienced, on average, a 90% reduction in menstrual blood loss from baseline at one year, with most women (70.6%) achieving amenorrhea. In addition, 59% of women with anemia at baseline experienced anemia improvement at one year. Lumbar spine and total hip bone mineral density were maintained over one year. The adverse event profile with relugolix combination therapy over one year was consistent with that observed in LIBERTY 1 and 2.
  

• Quality-of-Life Improvement with Relugolix Combination Therapy in Patients with Heavy Menstrual Bleeding Associated with Uterine Fibroids: Results from the LIBERTY Phase 3 Program (oral presentation, O-205)
  In this pooled analysis of data from the LIBERTY 1 and 2 studies, women who received relugolix combination therapy experienced a significantly greater reduction in symptom severity (scale from 0 to 100 with higher scores indicating worse outcomes) from baseline to Week 24 than women receiving placebo (33.5 vs. 12.1, nominal p < 0.0001). Women who received relugolix combination therapy also experienced a significantly greater improvement in total quality of life scores (scale from 0 to 100 with higher scores indicating better outcomes) from baseline to Week 24 compared to women receiving placebo (37.6 vs. 13.1, nominal p < 0.0001), which included assessment of daily activities, emotional wellbeing, and sexual function.