Primary endpoint met for new GnRH antagonist in advanced prostate cancer

Myovant Sciences, announced that the Phase III HERO study of once-daily, oral GnRH antagonist met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer.

The relugolix 120mg results support a submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020 and future regulatory submissions globally.

“An oral gonadotropin-releasing hormone (GnRH) antagonist for advanced prostate cancer has been an aspiration for many years,” said Dr Neal Shore, Medical Director of the Carolina Urologic Research Centre and HERO Program Steering Committee Member. “If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer.”

Approval in prostate cancer would put Myovant in competition for market share against drugs including leuprolide, goserelin, triptorelin, histrelin and degarelix. The faster onset of action of relugolix than leuprolide may be one potential differentiator.

In the primary endpoint responder analysis, 96.7% (95% CI: 94.9%, 97.9%) of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels.

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Five key secondary endpoints demonstrated superiority to leuprolide acetate. In addition, relugolix demonstrated non-inferiority to leuprolide acetate on sustained testosterone suppression through 48 weeks (96.7% vs. 88.8%, respectively) with a between-group difference of 7.9% (95% CI: 4.1%, 11.8%), the primary endpoint required for regulatory submissions outside of the U.S.

The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable.

“With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA,” said Lynn Seely, M.D., President and CEO of Myovant Sciences. “We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer.”

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