Joshi Alumkal, MD, highlights findings from the phase 3 ARASENS trial that led to the FDA approval of darolutamide for use in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.
In this video, Joshi Alumkal, MD, discusses the results of the phase 3 ARASENS trial, which supported the FDA approval of darolutamide (Nubeqa) for use in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (the FDA label for darolutamide states that patients receiving the treatment should also concurrently receive a GnRH analog or have had a bilateral orchiectomy).1
Alumkal is Wicha Family Professor of Oncology, professor, Department of Internal Medicine, section head, Prostate and Genitourinary Medical Oncology, associate division chief, Basic Research, Division of Hematology-Oncology, member, the University of Michigan Rogel Cancer Center, director, Epigenetic Therapy, Michigan Center for Translational Pathology.
For the past several years we've been using androgen receptor–signaling inhibitors along with ADT to treat patients with hormone-naive metastatic prostate cancer; or we're treating them with ADT plus docetaxel. But what we didn't know was the importance of the androgen receptor–signaling inhibitor darolutamide, or the value of adding an androgen receptor–signaling inhibitor to chemotherapy. And so the ARASENS trial was a randomized phase 3 clinical trial comparing androgen-deprivation therapy plus docetaxel plus placebo vs androgen-deprivation therapy plus docetaxel plus darolutamide. The study focused on patients with hormone-naive prostate cancer. And what that trial showed was that there was an improvement in survival for patients who are treated with triple combination therapy with ADT, docetaxel, and darolutamide vs the placebo arm. So the results strongly suggest that if you're going to give ADT and docetaxel, it's advantageous to add darolutamide to that combination vs omitting the darolutamide. And based upon the ARASENS results, the FDA approved darolutamide for use in combination with docetaxel and ADT in patients with newly diagnosed metastatic prostate cancer. And so it's an active regimen that we should all be considering in patients who present with metastatic disease.
Transcript has been edited for clarity.
1. Highlights of FDA prescribing information. NUBEQA® (darolutamide) tablets, for oral use Initial U.S. Approval: 2019. https://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI.pdf?inline