Dr. Schweizer on the Results of the HERO Trial in Prostate Cancer

Michael Schweizer, MD, a physician of the Seattle Cancer Care Alliance, assistant professor in the Division of Medical Oncology at the University of Washington School of Medicine, and associate professor in the Clinical Research Division at the Fred Hutchinson Cancer Research Center, discusses the results of the HERO trial in prostate cancer.

In the pivotal, phase 3 HERO trial, 934 patients with androgen-sensitive advanced prostate cancer were randomized 2:1 to receive 120 mg of oral relugolix (Orgovyx) once daily after a one-time 360 mg loading dose of relugolix or a 3-month depot injection of leuprolide (Lupron). 

 The results showed that 96.7% (95% CI, 94.9%-97.9%) of men treated with relugolix achieved and maintained castration through 48 weeks compared with 88.8% (95% CI, 84.6% to 91.8%) with leuprolide, translating to an absolute difference of 7.9% (95% CI, 4.1%-11.8%). As such, relugolix demonstrated noninferiority and superiority (P < 0.0001) versus leuprolide. Notably, all key secondary end points favored relugolix versus leuprolide (P < 0.0001) and patients had rapid recoveries of testosterone, Schweizer says. 

Although relugolix was associated with lower rates of major adverse cardiovascular events compared with leuprolide, the safety and tolerability profiles of the 2 agents were similar. Common adverse events for patients treated with relugolix or leuprolide were hot flash (54.3% vs 51.6%, respectively), fatigue (21.5% vs 18.5%), constipation (12.2% vs 9.7%), diarrhea (12.2% vs 6.8%), arthralgia (12.1% vs 9.1%), and hypertension (7.9% vs 11.7%), Schweizer concludes.