Results showed that once daily relugolix established superiority over leuprolide and reduced the incidence of major cardiovascular events.
Relugolix (Relumina), a once daily oral GnRH antagonist, induced sustained castration in 96.7% of patients with advanced prostate cancer and reduced the incidence of major cardiovascular events (MACE) when compared with leuprolide (Lupron), according to findings presented at the 2020 ASCO Virtual Scientific Program.
In an interview with CancerNetwork, Neal D. Shore, MD, FACS, from the Carolina Urologic research Institute discusses the findings from the phase III randomized, open-label HERO trial.
Well, our primary endpoint, which was designed to evaluate first non-inferiority of relugolix versus leuprolide over and continuously throughout a 48-week period. So indeed, we met the primary endpoint. And in fact, the between group difference was so significant that we also established our superiority in terms of testosterone suppression versus leuprolide. Regarding our secondary endpoints, they all were highly statistically significant regarding profound t[estosterone] suppression, in other words below 20 ng/dl and the correlative PSA reductions were there as well. And additionally, we found that follicle-stimulating hormone (FSH) suppression at week 24 also was highly statistically significant with relugolix versus leuprolide. In a subset of patients when we stopped therapy in both arms at the end of 48 weeks, within a 90-day period, 54% of the relugolix patients had established eugonadal or normal levels of testosterone whereas only 3% had done so in the leuprolide arm. And very significantly, as it related to looking at major adverse cardiovascular events, in this particularly at-risk population of elderly men with prostate cancer having testosterone suppression, there was a 54% reduction in the risk of a MACE regarding the relugolix patients as opposed to the leuprolide patients.