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.
... to read the full story