Myovant: No Statistical Superiority Achieved By Relugolix For Castration Resistance-free Survival

(RTTNews) - Myovant Sciences Ltd. (MYOV) on Tuesday announced results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer.

According to the company, Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks.

Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels. In the subgroup of men with metastatic disease treated with relugolix, 74 percent were castration-resistance free through 48 weeks, compared to 75 percent men treated with leuprolide acetate.

In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to prostate-specific antigen or PSA progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death from any cause.

Myovant Sciences noted that the incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in primary analysis of HERO with no new safety signals observed.

Relugolix is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020.

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. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34 percent of deaths in men with prostate cancer in the U.S.

More than three million men in the U.S. are currently living with prostate cancer, and approximately 190,000 men are estimated to be newly diagnosed in 2020.