Positive Phase III trial for relugolix versus leuprorelin for the treatment of uterine fibroids in Japanese women.- Myovant + Takeda.

Myovant Sciences announced that Takeda Pharmaceutical Company Limited has reported positive top-line results from a Phase III study evaluating the efficacy and safety of relugolix compared with leuprorelin for the treatment of uterine fibroids in Japanese women. Relugolix was statistically non-inferior to leuprorelin (p = 0.0013) meeting the study's primary endpoint, the proportion of patients achieving a pre-defined reduction in menstrual bleeding.

Takeda Phase III Study Design and Results: The Phase III trial was a multicenter, randomized, double-blind non-inferiority study conducted in Japan to evaluate the efficacy and safety of relugolix in approximately 280 women with heavy menstrual bleeding associated with uterine fibroids. Patients were randomized 1:1 to receive either relugolix 40 mg, administered orally once daily, or leuprorelin, administered by subcutaneous injection every four weeks, at a dose of 1.88 mg or 3.75 mg, for 24 weeks. Leuprorelin, or leuprolide acetate, is an injectable GnRH agonist approved for pre-operative treatment of uterine fibroids in Japan. The primary endpoint was the proportion of women who achieved a total score of less than 10 on the Pictorial Blood Loss Assessment Chart, or PBAC, a patient-reported outcome measure for evaluation of menstrual blood loss in clinical trials, from week 6 to week 12. All participants had a PBAC greater than 120 upon entry into the study. In the study, relugolix successfully demonstrated non-inferiority to leuprorelin with 82.2% of patients treated with relugolix achieving a score of less than 10 on the PBAC, compared with 83.1% of patients treated with leuprorelin (p = 0.0013).

The incidence of adverse events in the Phase III study was generally similar between treatment groups and consistent with the mechanism of action of the study medications. Takeda is conducting a second Phase III trial evaluating relugolix in approximately 70 Japanese women who have pain associated with uterine fibroids and anticipates preliminary top-line data in the fourth quarter of 2017. Takeda plans to submit the data from both studies to regulatory authorities in Japan for marketing authorization of relugolix for the treatment of uterine fibroids.

Comment: Myovant is currently conducting a Phase III clinical program consisting of two international, replicate pivotal clinical trials (LIBERTY 1 and LIBERTY 2), initiated in January 2017, of relugolix in women with heavy menstrual bleeding associated with uterine fibroids.