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Relugolix Elicits High Response Rate in Advanced Prostate Cancer

Gina Columbus @ginacolumbusonc
Published: Tuesday, Nov 19, 2019

 Neal Shore, MD, medical director of the Carolina Urologic Research Center and HERO Program Steering Committee Member

Neal Shore, MD

Treatment with relugolix achieved a high rate of sustained testosterone suppression to castrate levels in patients with androgen-sensitive advanced prostate cancer, meeting the primary endpoint of the phase III HERO trial (NCT03085095).1

Specifically, results showed that 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 (≤50 ng/dL) from weeks 5 through 48. The endpoint was met if the lower bound of the 95% confidence interval of the response rate was ≥90%. 

The data will serve as support for a new drug application (NDA) to the FDA, which is anticipated to be submitted in the second quarter for 2020, Myovant Sciences, the developer of the oral gonadotropin-releasing hormone (GnRH) receptor antagonist, stated in a press release. The company added that the findings will also be included in future regulatory submissions in Europe and Japan.

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