What Myovant Said About Relugolix
Myovant said the Phase 3 study dubbed HERO that evaluated once-daily oral relugolix 120mg in men with advanced prostate cancer met the primary efficacy endpoint, as well as six key secondary endpoints.
Relugolix is an oral gonadotropin-releasing hormone antagonist.
About 97% of men receiving relugolix achieved sustained testosterone suppression to castrate levels as opposed to the study criteria of at least 90% response rate.
Patients enrolled in the study were randomized 2:1 to receive a single loading dose of relugolix 360mg followed by 120mg once daily, or treatment with the standard-of-care leuprolide acetate 3-month depot injection, respectively.
Why Relugolix Is Important For Myovant And Prostate Cancer Treatment
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S., Myovant said. About 3 million men in the U.S. live with prostate cancer, with about 170,000 estimated to be newly diagnosed in 2019, the company said.
"We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer," said CEO Lynn Seely.
Armed with the results of the HERO study, the company plans to submit an NDA to the FDA in the second quarter of 2020. The study results also support regulatory submissions in Europe and Japan, it added.
Myovant shares were soaring by 64% to $9.95 at time of publication.