- 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.
- 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.
- 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).
- Open label.