PFE - Pfizer Myovant Sciences' relugolix combo shows positive action in uterine fibroids

Myovant Sciences (MYOV) and Pfizer (PFE) announce positive data from Phase 3 LIBERTY withdrawal study of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. The LIBERTY randomized withdrawal study met its primary endpoint with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52 (p < 0.0001).All three key secondary endpoints were also achieved, including sustained responder rate at two years (Week 104), time to relapse of heavy menstrual bleeding, and amenorrhea rate (all p < 0.0001).Through two years, 69.8% of women who continued on relugolix combo remained responders.88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return of 5.9 weeks.

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Pfizer, Myovant Sciences' relugolix combo shows positive action in uterine fibroids