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.
A LITTLE BELOW THE BELT 21
