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ANZUP’s ENZAMET trial is awarded all three of ACTA’s Trial of the Year Awards
ACTA 2020 Trial of the Year
ANZUP was extremely pleased to accept the award of the 2020 ACTA 2020 Trial of the Year for the ENZAMET Trial - Enzalutamide with Standard FirstLine Therapy in Metastatic Prostate Cancer.
This trial is an international, investigator-initiated, open-label, randomised phase 3 trial. It was designed to determine if the addition of enzalutamide to standard androgen deprivation therapy (ADT) improved overall survival (OS) in men with newly diagnosed, hormone-sensitive prostate cancer (mHSPC), compared with an active control arm of ADT plus a first generation non-steroidal antiandrogen (NSAA).
No other approach had demonstrated a survival benefit for mHSPC when ENZAMET was initiated in March 2014, so this represented a major area of unmet clinical need and a critical gap in the evidence.
Enzalutamide is a “next generation” NSAA that blocks androgen receptor signalling more effectively, and improves survival in men with metastatic castrationresistant prostate cancer (mCRPC).
The ENZAMET trial showed a 33% improvement in overall survival and a 60% improvement in progression-free survival, for men who received enzalutamide. This translated into 80% chance of survival at 3 years with enzalutamide versus 72% with NSAA. The results rapidly changed practice globally. Some clinicians were already using triplet therapy, and stopped doing so. Enzalutamide became a new standard of care. The US FDA approved enzalutamide for this indication on 16 December 2019, less than 10 months after the analysis was triggered. ASCO listed ENZAMET as one of its Clinical Cancer Advances for 2020, in its Annual Report on Progress Against Cancer, published in J Clin Oncol at https://ascopubs.org/ doi/10.1200/JCO.19.03141 on World Cancer Day, February 4, 2020.
“The ENZAMET clinical trial is testimony for a global collaboration to answer an important question that has generated clinically impactful data. We are greatly encouraged by the ability of enzalutamide to increase the longevity of men with mHSPC. The data and the biological samples collected will guide future trials with the goal to make more advances,” said Co-Chairs Prof. Christopher Sweeney and Prof. Ian Davis.
ENZAMET was able to demonstrate that it met each of the statistical planning, execution, and reporting and interpretation criteria specified by the ACTA Excellence in Trial Statistics application and were pleased to accept the 2020 STiNG Award for Excellence in Trial Statistics.
ACTA 2020 Consumer Involvement Award
ANZUP was also pleased to accept the ACTA 2020 Consumer Involvement Award as community involvement was key to the success of ENZAMET from the beginning.
ANZUP’s approach to all of its clinical trials is to centre the research question on its value to the community. Each trial has to address the following questions: What is the clinical need? How can we improve outcomes for those affected by genitourinary cancers? Where are the evidence gaps? What are our patients and their families telling us they require? This consumer-focused approach guides the entire ANZUP strategy.
The ANZUP Consumer Advisory Panel (CAP) plays a vital role in the provision of advice and feedback from a community perspective on ANZUP’s research strategy and priorities, and on community engagement and support. Our CAP provides a mechanism for advice on trial design and conduct, recruitment, and two-way communication strategies to support dissemination of research findings back to the community and to inform ANZUP of the community’s needs.
From the outset the CAP provided invaluable insight and advice on the ENZAMET trial from the patient’s perspective. They made a significant contribution to the patient information and consent form (PICF) through their lived patient experience, highlighting the importance and value of actively engaging consumers. In recognition of their contribution we now routinely include a statement that PICFs are reviewed by the ANZUP CAP. The CAP members provided advice around recruitment strategies for ENZAMET, working closely with us in developing our communication strategy to ensure the dissemination of information about the trial, and more recently the results were provided to the broader community in a timely fashion across multiple platforms.
Members of the ANZUP CAP are regarded by the ANZUP membership as indispensable participants at disease subgroup concept development workshops. Investigators benefit from having consumer input at the earliest stages of trial development which has considerable flow-on benefit through review and implementation phases.
“Clinical trials are the most effective way of determining which treatments, alone or in combination, will provide the greatest survival benefit to the patient with the least adverse outcomes.” ENZAMET Co-Chair Chair, Professor Chris Sweeney
