|
|
|
|
|
First and Only Oral GnRH Receptor Antagonist Orgovyx for the Treatment of Advanced Prostate Cancer
|
Alicia Morgans, MD, MPH and Charles Ryan, MD
Alicia Morgans, MD, MPH, and Charles Ryan, MD discuss Orgovyx and what it means to men being treated for advanced prostate cancer who now have an oral ADT treatment option. The FDA approval is based on the results of the randomized, open-label HERO trial in men with advanced prostate cancer. Orgovyx oral therapy, reduces the secretion of the hormone, testosterone, by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone, which effectively and rapidly suppresses testosterone.
|
|
|
|
|
|
|
|
|
| FDA Approves Myovant Sciences’ ORGOVYX (relugolix), the First and Only Oral GnRH Receptor Antagonist for Advanced Prostate Cancer
|
|
|
| The FDA has announced it has granted approval to Myovant Sciences for Orgovyx (relugolix) in the treatment of adult patients with advanced prostate cancer. Patients with advanced prostate cancer being treated with androgen deprivation therapy now have a once-daily oral treatment. Orgovyx, an oral therapy, reduce the secretion of the hormone, testosterone, by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone.
|
|
|
|
|
|
| Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer
|
| Neal Shore, MD, FACS; Fred Saad, MD, FRCS; Michael Cookson, MD, MMHC et al.
|
(Original Manuscript)
The HERO Phase III Trial comparing relugolix, an oral GnRH receptor antagonist, versus leuprolide acetate for advanced prostate cancer was published here in the New England Journal of Medicine. In this phase 3 trial, study investigators randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks. The primary end point was sustained testosterone suppression to castrate levels (<50 ng per deciliter) through 48 weeks. |
|
|
|
|
|
| HERO Phase III Trial: Results Comparing Relugolix, an Oral GnRH Receptor Antagonist, versus Leuprolide Acetate for Advanced Prostate Cancer
|
| Neal D. Shore, MD, FACS
|
| At the 2020 American Society of Clinical Oncology virtual annual meeting, Neal Shore presented results of the phase III results of the HERO Trial comparing the safety and efficacy of relugolix with leuprolide acetate in advanced prostate cancer patients. Relugolix achieved castration as early as day 4 and demonstrated superiority over leuprolide in sustained testosterone suppression through 48 weeks.
|
|
|
|
|
|
|
|
|
|
|
PEER-TO-PEER CLINICAL CONVERSATIONS |
|
|
|
|
|
|
Androgen Deprivation With Oral Relugolix vs Leuprolide in Advanced Prostate Cancer: HERO Trial
|
|
Neal Shore, MD, FACS
|
| Lead author on the HERO Phase 3 Trial, Neal Shore presents the HERO Trial data published in the NEJM in May. Relugolix, an oral GnRH receptor antagonist, vs leuprolide acetate, a three-month formulation for advanced prostate cancer patients. This data, first presented at ASCO 2020 this year, showed 96.7% response rate for men with relugolix for T suppression sustained over 48 weeks. As it relates to safety and tolerability, a 54% decrease in the risk of a major adverse cardiovascular event compared to leuprolide.
|
|
|
|
|
|
|
|
|
|
|
|
|
The HERO Study – Reviewing Major Adverse Cardiovascular Results
|
|
Bertrand Tombal, MD, Ph.D.
|
| Bertrand Tombal joins Alicia Morgans to report on the cardiovascular result of the HERO relugolix Phase III Trial and the cardiovascular risks from a urologist's perspective of ADT in men with prostate cancer.
|
|
|
|
|
|
|
|
|
|
|
|
|
Contemporary Treatment Strategies For Androgen Deprivation Therapy In Prostate Cancer
|
Michael Cookson, MD, MMHC, Alicia Morgans, MD, MPH, Fred Saad, MD, FRCS, and Neal Shore, MD, FACS
In this multidisciplinary roundtable, lead author of the HERO Trial Neal Shore, is joined by Fred Saad, Alicia Morgans, and Michael Cookson. They review the HERO Phase III Trial of once-daily oral GnRH receptor antagonist for advanced prostate cancer. They highlight the study's cardiovascular results, its faster testosterone recovery, and the potential for relugolix to become a new standard for testosterone suppression for patients with advanced prostate cancer.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
