Relugolix (OrgovyxTM, Myovant Sciences) was recently FDA approved as the first oral hormone therapy for patients with advanced prostate cancer. In this interview, Neal Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center and lead investigator of the HERO trial, on which the approval was based, speaks with i3 Health about the approval's significance and the future of treatment for patients with this disease.
Can you comment on the significance of the approval of relugolix for patients with advanced prostate cancer?
Neal Shore, MD, FACS: With this approval, relugolix is the first and only oral medication to effectively achieve testosterone suppression in patients with advanced prostate cancer who will benefit from androgen deprivation therapy (ADT). The once-daily administration is much simpler and more easily accomplished than traditional injectable medications that are given either subcutaneously or intramuscularly. This will allow for greater convenience for both patients and clinics, and it is especially significant during the time of a pandemic.
Are there any particular adverse events that should be monitored for in patients receiving relugolix?
Dr. Shore: The adverse events that patients might expect with relugolix are very much consistent with those experienced with any medication that causes testosterone suppression. These include hot flashes, fatigue, decreased libido, and quasi-metabolic syndrome, all of which have been well described over the years. Fortunately, most of these adverse events can be anticipated and proactively treated. Notably, the phase 3 HERO trial demonstrated a decreased risk of cardiovascular toxicity for the relugolix arm compared with the luteinizing hormone-releasing hormone (LHRH) agonist arm.
How do you foresee the treatment of advanced prostate cancer evolving in the coming years?
Dr. Shore: The treatment of advanced prostate cancer will continue to evolve as it has done in the last decade, especially as we now have a better understanding of approved therapeutics and why they develop resistance mechanisms. With that knowledge, we strive for specific drug targets and newer therapeutics to delay prostate cancer progression and ultimately prevent patients from dying of the disease. I am extremely optimistic that we will continue to have novel therapeutics that will not only prolong survival for patients with advanced prostate cancer, but also preserve their quality of life and minimize the risk of complications from therapy.
What questions do you commonly encounter from patients with advanced prostate cancer, and how do you counsel them?
Dr. Shore: Receiving a diagnosis of cancer, whether it's prostate cancer or another type, is a life-altering event. It creates tremendous anxiety and fear for patients and their families. The questions that patients ask—or may be sometimes be afraid to ask—are, "How long will I live?" "Will the therapies affect my day-to-day-living?" "What will the complications of therapy be, and why will I take one therapy versus another?" "If the therapy stops working, how do we make a decision to switch to a different one?"
We have had a remarkable number of new treatments for patients with advanced prostate cancer; since 2010, we've seen nine FDA approved therapies that have prolonged patients' survival. The challenge for health care providers is to understand the optimal timing and evaluation for ongoing therapies, as well as the ongoing clinical trials which will continue to provide important data for the regulatory agencies to advance the approval of additional therapeutic options.
About Dr. Shore
Neal Shore, MD, FACS, is the Medical Director of the Carolina Urologic Research Center in Myrtle Beach, South Carolina. He is an internationally recognized expert in the treatment of patients with advanced urologic cancers, including kidney, bladder, and prostate cancer. Dr. Shore serves on several medical committees, including the Boards of the Society of Urologic Oncology, the Bladder Cancer Advocacy Network, the Society for Immunotherapy of Cancer Prostate Committee, and the Duke Global Health Institute. He is also a reviewer for numerous peer-reviewed journals, including European Urology, Journal of Urology, Lancet Oncology, and the New England Journal of Medicine. Dr. Shore has authored over 200 publications focusing on the development of novel therapeutics for urologic cancers.
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Transcript edited for clarity. Any views expressed above the speaker's own and do not necessarily reflect those of i3 Health.