Pfizer and Myovant Sciences have announced that relugolix combination therapy could have ‘potential benefit’ for the long-term treatment of women with uterine fibroids.
The LIBERTY randomised withdrawal study enrolled women who had previously competed the LIBERTY long-term extension study.
Women were randomised at week 52 to receive once-weekly relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) or placebo for a one-year treatment period.
The 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) compared with 15.1% of women who discontinued treatment through week 76.
The study also hit three key secondary endpoints, including sustained responder rate at two years, time to relapse of heavy menstrual bleeding and amenorrhea (absence of menstruation) rate.
In addition, through two years, 69.8% of women who continued on relugolix treatment remained responders, with 88.3% of women who discontinued treatment at week 52 relapsing with heavy menstrual bleeding.
“We are pleased to see the positive data from the LIBERTY randomised withdrawal study which supports the potential benefit of longer-term treatment with relugolix combination therapy,” said Juan Camilo Arjona Ferreira, chief medical officer of Myovant Sciences.
“Uterine fibroids can affect many women during their lifetime with uncomfortable symptoms, such as heavy menstrual bleeding,” said James Rusnak, senior vice president, chief development officer, internal medicine and hospital, global product development at Pfizer.
“We believe that these study results offer encouraging data in support of longer-term efficacy in women suffering from uterine fibroids,” he added.
The US Food and Drug Administration (FDA) is currently review relugolix combination therapy for the treatment of women with uterine fibroids, with a decision expected by 1 June 2021.