Myovant Sciences Ltd (MYOV)

[MDizzle]

Myovant, Pfizer See Positive Data From Uterine Fibroids Therapy Study


By Chris Wack


Myovant Sciences Ltd. and Pfizer Inc. said Wednesday they saw positive data from the Phase 3 study of relugolix combination therapy in women with uterine fibroids.

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

The study met its primary endpoint, with 78.4% of women who continued on relugolix combination therapy achieving the sustained responder rate of 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, the companies said.

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, the companies said. And 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.

The incidence of adverse events over one additional year of treatment was consistent with those observed in prior studies, with no new safety signals observed. The most commonly reported adverse event in at least 10% of women treated with relugolix combination therapy was nasopharyngitis.

Relugolix combination tablet is under review by the U.S. Food and Drug Administration for the treatment of women with uterine fibroids, with a decision expected by the June 1, 2021, target action date.