Myovant Sciences announces publication of abstracts detailing efficacy and safety from phase III LIBERTY studies in uterine fibroids in Obstetrics & Gynecology journal.

Myovant Sciences announced that the journal Obstetrics & Gynecology has published three abstracts detailing additional efficacy and safety findings from the Phase III LIBERTY 1 and 2 studies of 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 abstracts were originally accepted for presentation in oral and poster sessions at the American College of Obstetricians and Gynecologists (ACOG) 2020 Annual Clinical and Scientific Meeting, which was cancelled due to the COVID-19 pandemic.Abstracts are available in Obstetrics & Gynecology.

Details of the abstracts are as follows. 1. “Relugolix Combination Therapy Reduced Uterine Fibroid-Associated Pain in Two Phase III LIBERTY Studies (Abstract #32B)”- The pain-evaluable population included 127 and 150 women from LIBERTY 1 and 2 studies, respectively, who experienced moderate to severe pain before randomization and completed the 24-week study. In an analysis of pooled data: 65% of women treated with relugolix combination therapy reported no or minimal pain during menstrual days (maximum score of 1 on a 0 to 10 Numerical Rating Scale) compared to 19.3% for women in the placebo group. 44.6% of women treated with relugolix combination therapy reported no or minimum pain during non-menstrual days, compared to 21.6% of women in the placebo group.

2. “Relugolix Combination Improves Quality of Life in Phase III Studies of Symptomatic Uterine Fibroids (Abstract #OP04-4D).: Women in both LIBERTY 1 and LIBERTY 2 studies completed the validated Uterine Fibroid Symptom (UFS)-Quality of Life (QoL) questionnaire: Women treated with relugolix combination therapy experienced significant improvement in symptom severity (scale from 0 to 100 with higher scores indicating worse outcomes) from baseline to Week 24 (both studies p < 0.0001) from 55.1 to 23.4 compared with 60.3 to 49.2 for women in the placebo group in LIBERTY 1, and from 59.1 to 21.7 compared with 59.2 to 45.1 for women in the placebo group in LIBERTY 2. Health-related QoL (scale from 0 to 100 with higher scores indicating better outcomes) also improved significantly for women treated with relugolix combination therapy from baseline to Week 24 (both studies p < 0.0001) from 37.2 to 74.0 compared with 33.5 to 44.9 for women in the placebo group in LIBERTY 1, and from 38.9 to 78.7 compared with 37.3 to 51.0 for women in the placebo group in LIBERTY 2.

3. Bone Mineral Density Assessment with Relugolix Combination Therapy: “Results from the Phase III LIBERTY Program (Abstract #OP04-2D) “- Results demonstrated that relugolix combination therapy preserved bone mineral density over 24 weeks in the LIBERTY program. In contrast, relugolix monotherapy for 12 weeks was associated with bone mineral density loss, which stabilized upon transition to relugolix combination therapy for 12 weeks. These data suggest that initiating treatment for uterine fibroids with relugolix combination therapy represents a potential treatment option for preserving bone mineral density while providing long-term therapeutic benefit.

See- : “Relugolix Combination Improves Quality of Life in Phase III Studies of Symptomatic Uterine Fibroids [OP04-4D]”-Lukes, Andrea S.; Poindexter, Alfred III; Villarroel, Claudio; More
Obstetrics & Gynecology. 135:7S, May 2020.

See- “Relugolix Combination Therapy Reduced Uterine Fibroid-Associated Pain in Two Phase III LIBERTY Studies [32B]”- Stewart, Elizabeth A.; Lukes, Andrea S.; Venturella, Roberta; More
Obstetrics & Gynecology. 135:27S, May 2020.