The results of a phase III long-term extension study show that once-daily therapy of Relugolix with estradiol and norethindrone acetate leads to a clinically meaningful reduction in menstrual pain and non-menstrual pelvic pain in women with endometriosis for over one year.
The study was part of the SPIRIT study by Myovant Sciences and Pfizer, which looked at the use of Relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg in women with endometriosis for 52 weeks.
Myovant and Pfizer went one Cooperation agreement in December, with the aim of developing and commercializing Relugolix in both oncology and women’s health in the US and Canada. The two companies also plan to develop and commercialize Relugolix in advanced prostate cancer.
If approved, Myovant Sciences and Pfizer will also attempt to develop a combination regimen with Relugolix, estradiol, and norethindrone acetate for uterine fibroids and endometriosis.
In the Phase III trial, the two companies attempted to evaluate their Relugolix combination treatment for endometriosis, an estrogen-dependent inflammatory disease. In this disease, endometrial-like tissue outside the uterine cavity leads to chronic inflammation and ultimately to scars and adhesions.
The positive results from the extension study, believed to be consistent with the efficacy and safety data in the Phase III SPIRIT 1 and SPIRIT 2 studies, will be used in a new drug application that is expected to be filed with the US Food and Drug Administration will be submitted in the first half of 2021.
“Given the debilitating effects endometriosis can have on women in their daily lives, often over many years, we need non-invasive and long-term treatment options,” said a Explanation Made by Linda Giudice, MD, Ph.D., Distinguished Professor at the University of California, San Francisco’s Center for Reproductive Science (UCSF) and a member of the SPIRIT Program Steering Committee. “The year-long data from the Phase 3 SPIRIT extension study offers promising evidence that Relugolix combination therapy has the potential to provide significant and lasting pain relief in women with endometriosis while being well tolerated.”
Clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain were reported in 84.8% and 73.3% of women who received Relugolix combination therapy during the one year study period. Over 52 weeks, women reported an average decrease in the numerical rating scale (0-10) for dysmenorrhea by 82.8% from 7.4 (severe pain) to 1.3 (mild pain).
“Building on our annual data on Relugolix combination therapy for uterine fibroids, we are pleased to announce the annual safety and efficacy data in women with endometriosis that further our vision of a once-a-day pill treatment option that is suitable for long-term use in both diseases,” said Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, MD. “We look forward to submitting a new drug application in the first half of this year for this potential new treatment for women with endometriosis.”
Throughout the study, the researchers observed a relatively stable bone mineral density in all patients treated with the combination therapy. By week 24 there was minimal, but not clinically meaningful, bone loss. No new safety signals were found with the treatment compared to the safety results from the SPIRIT 1 and SPIRIT 2 studies. Commonly reported adverse events (≥ 10 participants) in the active treatment group included headache, nasopharyngitis, and hot flashes.
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