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ENZAMET Trial: Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

Curated by Clinicians: Educational Forum with Videos, Abstracts and Conference Information
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Articles and Abstracts

Men who initially present with localized prostate cancer and later develop metachronous metastases have a better prognosis than men with de novo metastatic disease and often have a low burden of disease on conventional imaging.

Evidence has been presented in the last seven years that has transformed the management of metastatic hormone-sensitive prostate cancer (mHSPC). The principles of management for about seven decades had fundamentally been around testosterone suppression. We now have clear data for the benefit of docetaxel (CHAARTED, STAMPEDE), abiraterone (LATITUDE, STAMPEDE), apalutamide (TITAN), and enzalutamide (ARCHES, ENZAMET).
San Francisco, CA (UroToday.com) -- The Australian Clinical Trials Alliance (ACTA) has recognised the remarkable Australians who advance the health system through clinical trials at the virtual Clinical Trials 2020: National Tribute and Award Ceremony.
San Francisco, CA USA (UroToday.com) -- Astellas Pharma Inc. and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI®(enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC).
BACKGROUND: Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer.
Conference Coverage
Conference Highlights Written by Physician-Scientist
Presented by Daniel J. George, MD
There are a number of treatment options that have been shown to improve overall survival in mCSPC, including docetaxel and novel hormonal therapies including abiraterone acetate, enzalutamide, and apalutamide. While these agents have proven beneficial in clinical trials, improvement in population-level outcomes depends on their widespread adoption. 
Presented by Stephen J. Freedland, MD
There are a number of treatment options that have been shown to improve overall survival, including docetaxel and novel hormonal therapies including abiraterone acetate, enzalutamide, and apalutamide. While these agents have proven beneficial in clinical trials, improvement in population-level outcomes depends on their widespread adoption. Dr. Freedland presented results of an analysis of Medicare data regarding real-world utilization of these agents in men with mCSPC.
Presented by Arun Azad, MBBS, PhD, FRACP
Enzalutamide plus ADT is approved in the US and Europe to treat castration-resistant prostate cancer and was also recently approved for men with metastatic hormone-sensitive prostate cancer (mHSPC) in the US. In ARCHES, enzalutamide plus ADT reduced the risk of the primary endpoint of radiographic progression-free survival events (by 61%), and improved key secondary endpoints versus placebo plus ADT in men with mHSPC.
Presented by Ian Davis, MBBS, PhD, FRACP, FAChPM
The 2020 Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) Mini Annual Scientific Meeting featured a session on ANZUP trial updates, including an update of the critical Phase III ENZAMET trial provided by Drs. Ian Davis, Arun Azad, and Lisa Horvath.
Presented by Neal D. Shore, MD, FACS
Dr. Shore from the Carolina Urologic Research Center presented a plenary talk discussing the multitude of hormonal treatment options for patients with metastatic castration sensitive prostate cancer (mCSPC). Dr. Shore began by highlighting data from Dr. Huggins seminal work demonstrating that prostate cancer is hormone dependent.
Presented by Alicia Morgans, MD, MPH
San Francisco, California (UroToday.com) Dr. Alicia Morgans, Associate Professor and Medical Oncologist at Northwestern University Feinberg School of Medicine, presented some of the most influential articles from the past year in the field of prostate cancer research from a medical oncology perspective.
Presented by Henrik Gronberg, MD, PhD
Barcelona, Spain (UroToday.com) At the prostate cancer poster discussion at ESMO 2019, Dr. Henrik Gronberg provided a discussion of three important abstracts: the updated STAMPEDE “M1|RT Comparison”, as well as patient reported outcomes from both ENZAMET and TITAN.
Presented by Martin R. Stockler, MBBS(Hons) MSc(Clin Epi) FRACP
Barcelona, Spain (UroToday.com)  At 2019 ASCO meeting, Davis and colleagues previously reported that treatment with enzalutamide rather than an older non-steroidal anti-androgen (bicalutamide, nilutamide, or flutamide), resulted in longer overall survival 
Presented by Tanya B. Dorff, MD
Chicago, IL (UroToday.com) The presentation of ENZAMET, overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial, by Christopher Sweeney, MBBS, was followed by Tanya B. Dorff, MD, of City of Hope Cancer Center,
Presented by Christopher Sweeney, MBBS
Chicago, IL (UroToday.com) Abiraterone and docetaxel are both standard of care options for available for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the United States. 
Presented by Christopher Sweeney, MBBS
Chicago, IL (UroToday.com) Testosterone suppression is the backbone of treatment for metastatic hormone-sensitive prostate cancer (mHSPC), however, until 2014, testosterone suppression +/- standard nonsteroidal antiandrogen was the only therapy available. 
Presented by Thenappan Chandrasekar, MD
The introduction of androgen-axis targeted therapies has drastically altered the landscape of advanced prostate cancer. Abiraterone acetate (AA) and enzalutamide (ENZA) have been driving the change, and have been utilized in even earlier stages of advanced prostate cancer. Two recent studies, STAMPEDE, and LATITUDE,1,2 have established the utility of adding AA + prednisone to ADT among men with high‐risk, hormone‐naïve PCa.