Advanced prostate cancer: oral relugolix is superior to leuprolide in phase 3

  • Shore ND & al.
  • N Engl J Med
  • 4 Jun 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Oral relugolix achieves rapid and superior testosterone suppression vs leuprolide in patients with advanced prostate cancer.
  • Relugolix also has lower risk for major adverse cardiovascular events (MACE).

Why this matters

  • Relugolix may become the new standard of care for advanced prostate cancer.

Study design

  • Phase 3 HERO trial of 934 patients with advanced prostate cancer, randomly assigned 2:1 to receive oral relugolix or leuprolide depot injections for 48 weeks.
  • Funding: Myovant Sciences.

Key results

  • 96.7% of patients in the relugolix group maintained testosterone suppression to castrate levels through 48 weeks vs 88.8% in the leuprolide group.
    • The difference of 7.9 percentage points (95% CI, 4.1-11.8) showed noninferiority and superiority of relugolix (P<.001 for superiority>
  • Relugolix showed superiority in key secondary endpoints (all P<.001>
  • Cumulative probability of castration at day 4 (56.0% vs 0%) and on day 15 (98.7% vs 12.0%).
  • Testosterone suppression to profound castrate levels (
  • Confirmed PSA response at day 15 (79.4% vs 19.8%).
  • Follicle-stimulating hormone suppression at week 24 (mean, 1.72 vs 5.95 IU/L).
  • Grade 3-4 adverse event rates were 18.0% with relugolix and 20.5% with leuprolide.
  • The risk for MACE was lower with relugolix (HR, 0.46; 95% CI, 0.24-0.88).
  • Limitations

    • Open label.