Myovant Sciences (NYSEMYOV) has announced the results of an additional secondary endpoint from its third phase HERO trial evaluating relugolix in treating men with advanced prostate cancer. The results announced that relugolix failed to achieve statistical advantage for castration resistance-free survival relative to leuprolide acetate in men having metastatic disease through 48 weeks.
Patients who receive relugolix remained castration resistant-free
Dan George, HERO program committee member, said that from the new results in the Phase 3 HERO trial showed that three of the four men having metastatic prostate cancer who received relugolix remained castration-resistant free up to 48 weeks. This was in comparison with leuprolide acetate injections, which is the standard of care. George, a medicine and surgery professor at Duke University School of Medicine, said that they are delighted with the potential of relugolix as a potentially novel and differentiating treatment alternative for prostate cancer patients. This is because of the string safety and clinical data that include a lower risk of adverse cardiovascular events relative to leuprolide acetate.
Despite obtaining testosterone suppression to castrate levels castration-resistant prostate cancer is often defined by disease progression. In the cohort of the patients treated with relugolix for the metastatic disease, 74% were reportedly castration-resistant free after 48 weeks compared to 75% in men that received leuprolide acetate treatment. In the analysis of the secondary endpoint, castration-resistant-free survival at the time was defined from the first dose to prostate-specific antigen progression.
Myovant expects a target action date in December
Myovant Sciences CEO Lynn Seely said that they believe the totality of data, which includes previously reported results from the Phase 3 Hero study, presents captivating evidence for using relugolix in treating advanced prostate cancer patients. Seely added that with their NDA under Priority Review by the US Food and Drug Agency, they look forward to the target action date expected in December. Further, the company hopes to advance its commitment to redefining care by delivering the once-per-day oral relugolix treatment for prostate cancer patients.