Benzinga | Mar 24, 2021 08:23AM EDT

Myovant/Pfizer's Relugolix Combo Therapy Shows Sustained Clinical Benefit In Uterine Fibroids

Myovant Sciences Ltd (NYSE: MYOV) and Pfizer Inc (NYSE: PFE) have announced positive data from the Phase 3 LIBERTY randomized withdrawal study evaluating relugolix combination therapy in women with uterine fibroids.

* The therapy includes relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg.

* The study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.

* 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate (menstrual blood loss of less than 80 mL) through Week 76 compared with 15.1% of women who discontinued treatment and initiated placebo at Week 52.

* All three key secondary endpoints were also achieved, including sustained responder rate at two years, time to relapse of heavy menstrual bleeding, and amenorrhea rate.

* Through two years, 69.8% of women who continued on relugolix combination therapy remained responders.

* 88.3% of women who discontinued treatment at Week 52 relapsed with heavy menstrual bleeding, with a median time of return to heavy menstrual bleeding of 5.9 weeks.

* Bone mineral density was maintained through two years in the subset of women continuously treated with relugolix combination therapy (N=31).

* No new safety signals were observed.

* Relugolix combination tablet is under review by the FDA to treat women with uterine fibroids, with a decision expected by June 1.

* Myovant will hold a webcast and conference call at 8:30 a.m. E.T. today.

* Price Action: PFE shares are up 0.3% at $35.45, and MYOV shares are trading 1.5% higher at $23.75 in premarket trading on the last check Wednesday.