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Relugolix: Novel Drug for ADT in Advanced Prostate Cancer

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An investigational new drug for androgen deprivation therapy (ADT) in prostate cancer has shown superiority over the standard therapy leuprolide, and could change practice once it is available, experts have suggested.

The new drug is relugolix (Relumina, Myovant Sciences), an oral gonadotropin-releasing hormone (GnRH) antagonist already approved in Japan for use in the treatment of uterine fibroids.

Relugolix has the “potential to become a new standard for ADT and advanced prostate cancer,” commented Neal D. Shore, MD, medical director for the Carolina Urologic Research Center, Myrtle Beach, South Carolina.

He is lead author of the phase 3 HERO trial in more than 900 patients, a study that met its primary endpoint, demonstrating that castration at 48 weeks was maintained in 96.7% of men vs 88.8% for patients using leuprolide.

Notably, relugolix also cut the risk of major adverse cardiovascular events by 54% as compared to leuprolide, he noted.

This could be an important advantage, he suggested. “The percentage of patients with prostate cancer dying of cardiovascular disease has surpassed the percentage of patients dying from prostate cancer itself since the early 1990s,” Shore noted. “Approximately 30% of men with prostate cancer have known cardiovascular disease, and many more of these patients have comorbid risk factors including obesity, diabetes, hypertension, and hyperlipidemia.”

Shore presented the study results during the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) annual meeting, and they were also published simultaneously in the New England Journal of Medicine.

At the meeting, David R. Wise, MD, PhD, assistant professor of medicine and urology at Perlmutter Cancer Center at NYU Langone Health, New York City, agreed that the drug could be practice-changing — but he emphasized that it would be for a subset of patients only.

“For patients with a significant history of cardiovascular disease and without GI malabsorption, I will use this to avoid the injection site reactions commonly experienced with degarelix,” said Wise, who was not involved with the HERO study.

He also cautioned that, as with any oral medication, noncompliance will be an issue, especially when used as monotherapy. “Patients will need to be monitored more frequently, with more frequent serum testosterone checks,” he said.