Neal D. Shore, MD, FACS, discusses the results from the phase 3 HERO trial with relugolix in men with advanced prostate cancer.
Neal D. Shore, MD, FACS, medical director of the Carolina Urologic Research Center, discusses the results from the phase 3 HERO trial with relugolix in men with advanced prostate cancer.
The global, pivotal HERO trial showed that relugolix was superior to leuprolide (Lupron) in patients with advanced prostate cancer. The testosterone (T) suppression through 48 weeks was initially examined in the HERO study, says Shore. In the relugolix arm, a 96.7% T suppression was reported, with a definition of 50 ng/dL as the threshold, and 88.8% in the leuprolide arm. The difference between the groups was 7.9% and the lower-bound confidence interval was met with a -10% noninferiority margin. These results showcased the superiority of T suppression with relugolix through week 48, says Shore.
Key secondary end points of the trial included T suppression described as profound or below 20 ng/dL at day 15, as well as levels of T suppression throughout the study. Additionally, the corollary prostate-specific antigen responses and the mean FISH levels at week 24 were examined. The secondary end points revealed that relugolix was superior when compared with the leuprolide arm; the P values for all those end points were highly statistically significant, concludes Shore.