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ASCO20: HERO Trial Compares Relugolix and Leuprolide Acetate in Advanced Prostate Cancer

By: Celeste L. Dixon
Posted: Monday, June 1, 2020

Results of the phase III HERO trial indicated the first oral gonadotropin-releasing hormone receptor antagonist for medical castration in advanced prostate cancer, relugolix, may be more effective than leuprolide acetate in sustaining testosterone suppression through 48 weeks. It also promoted “faster testosterone recovery after discontinuation and a 50% reduction in major adverse cardiovascular events,” according to Neal D. Shore, MD, of Carolina Urologic Research Center, Myrtle Beach, South Carolina, and colleagues. Their work was presented during the ASCO20 Virtual Scientific Program (Abstract 5602) and simultaneously published in The New England Journal of Medicine.

The trial’s primary endpoint was the achievement and maintenance of serum testosterone suppression to castration levels (< 50 ng/dL) through 48 weeks. According to the investigators, this endpoint was met by 96.7% of men treated with relugolix versus 88.8% of those who received leuprolide acetate (P < .0001). The trial included 934 patients with androgen-sensitive advanced prostate cancer who were randomly assigned 2:1 to receive relugolix at 120 mg orally once daily or a leuprolide acetate 3-month depot injection.

“All key secondary efficacy endpoints tested demonstrated [relugolix’s] superiority over leuprolide (P < .0001)” as well, noted Dr. Shore and co-investigators. Furthermore, beyond the cardiovascular protection offered by relugolix, the safety and tolerability profiles of the agents were generally similar. Specifically, the incidence of major adverse cardiovascular events was reported to be lower with relugolix than with leuprolide acetate (2.9% vs. 6.2%).

“Relugolix has the potential to become a new standard for testosterone suppression for patients with advanced prostate cancer,” proposed the study authors.

Disclosure: The study authors’ disclosure information can be found at coi.asco.org.



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