Welcome to the second issue of Everyday Urology – Oncology Insights of 2020, published by Digital Science Press. Throughout the year, UroToday.com has provided information and expert perspectives on the evolving state of urology and GU oncology, as well as the impact COVID-19 has had on the healthcare environment, featuring video discussions amongst physicians at the frontlines of care and research. These videos, along with discussions of conference updates, journal clubs and the cancer patient journey series are featured on the UroToday.com website. This issue focuses on advances in the management of prostate cancer, as well as the ASCO 2020 virtual meeting held May 29-31, 2020.
In their article, “What is Changing in Advanced Prostate Cancer?” Christopher J.D. Wallis, MD, Ph.D., and Zachary Klaassen, MD, profile the ways in which advanced prostate cancer treatment has been revolutionized over the last 15 years, as no less than nine novel agents have been introduced with proven overall survival benefits. Reviewing the evidence that has defined these changes, Dr. Wallis and Dr. Klaassen detail the pivotal trials and FDA approvals that have demonstrated survival benefits across metastatic castration-resistant prostate cancer (mCRPC), metastatic castration sensitive prostate cancer (mCSPC) and nonmetastatic castration-resistant prostate cancer (nmCRPC), beginning with the introduction of docetaxel for men with castration-resistant prostate cancer in 2004, and continuing through recent phase 3 trials as well as reviewing novel treatment strategies.
This issue’s expert perspective article focuses on the ARAMIS trial results updated at ASCO 2020. Darolutamide is a unique androgen receptor inhibitor which the FDA approved in July 2019 for the treatment of nonmetastatic castration-resistant prostate cancer. This approval was based on ARAMIS, a large multicenter, double-blind, placebo-controlled study that randomized 1500 patients to 600 milligrams of darolutamide twice a day or placebo. The primary endpoint was metastasis-free survival, which was defined as the time from randomization to the first evidence of distant metastases or death. Data reported at a prior conference showed that ARAMIS met its primary endpoint of improving metastasis-free survival over placebo (40.4 months vs 18.4 months, HR 0.41) while demonstrating a favorable safety profile. This presentation provides updated data on this registrational study including the much-anticipated overall survival results. The overall survival analysis was conducted after 254 deaths were observed in the study. Cross-over was allowed in the study and 170 patients receiving placebo crossed over to darolutamide. In terms of overall survival, darolutamide had a 31% reduction in the risk of death compared with placebo alone. At 3 years, 93% of patients were alive in the darolutamide arm compared with 77% of patients in the placebo arm. The benefit in overall survival is seen despite more than half the patients in the placebo arm subsequently receiving darolutamide or life-prolonging mCRPC therapies. These findings of ARAMIS support darolutamide as an option for patients with nmCRPC.
We are honored to present a spotlight section summarizing presentations from the virtual 2020 American Society of Clinical Oncologists Annual Meeting. While the conference was presented in an entirely virtual format for the first time since it originated in 1965 due to the ongoing COVID-19 pandemic, ASCO 2020 did not fail to provide clinicians the opportunity to present recent data and updates. At ASCO 2020, results from the phase III HERO trial, which randomized patients to receive the oral GnRH receptor antagonist, relugolix, versus injectable leuprolide was presented. The HERO trial demonstrated both non-inferiority and superiority for relugolix vs. leuprolide regarding the primary endpoint of testosterone suppression. Other key secondary endpoints and safety analyses were also met and reviewed during an ASCO 2020 plenary and simultaneously published in The New England Journal of Medicine. The CARD, CONDOR, JAVELIN, TheraP, PROSPER, and other important clinical trials and results were also featured. We are pleased to provide you with coverage from these practice-changing clinical trial results.
To accompany this written conference coverage, UroToday interviewed leaders in the field, inviting these experts to contextualize their ASCO 2020 presentations and expand on their findings on UroToday.com.
This issue of Everyday Urology – Oncology Insights promises up-to-date coverage of continued progress in the fields of GU-oncology. Even when the COVID-19 pandemic sent ASCO’s annual meeting into a virtual space and made telehealth clinic visits a mainstay of clinical treatment, new research was still published and we highlight some of those important, new advances. We wish you good health and safety this summer.
Neal Shore, MD, FACS
What is Changing in Advanced Prostate Cancer?
ARAMIS: Favorable Overall Survival and Safety Findings for Darolutamide in Nonmetastatic Castration-Resistant Prostate Cancer
Download: Everyday Urology — Oncology Insights, Volume 5 Issue 2