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ASCO 2025 | ARCHES: 5-year OS analysis of enzalutamide plus ADT in mHSPC

Andrew Armstrong, MD, MS, Duke Cancer Institute, Durham, NC, discusses the 5-year overall survival (OS) analysis from the Phase III ARCHES trial (NCT02677896) of enzalutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Extended follow-up confirmed sustained survival benefits with enzalutamide plus ADT over placebo plus ADT, including in high- and low-volume disease subgroups. These findings highlight the long-term efficacy and durability of response with this combination approach. This interview took place during the 2025 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.

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Transcript

In 2025 at ASCO, we presented the five-year follow-up of the ARCHES trial. The ARCHES trial randomized patients with metastatic hormone-sensitive prostate cancer to androgen deprivation therapy and placebo or enzalutamide plus androgen deprivation therapy. The ARCHES trial many years ago, about five years ago now, led to the FDA approval of this regimen because it delayed progression-free survival by over 60% and two years later we showed that this combination improved overall survival in 2021...

In 2025 at ASCO, we presented the five-year follow-up of the ARCHES trial. The ARCHES trial randomized patients with metastatic hormone-sensitive prostate cancer to androgen deprivation therapy and placebo or enzalutamide plus androgen deprivation therapy. The ARCHES trial many years ago, about five years ago now, led to the FDA approval of this regimen because it delayed progression-free survival by over 60% and two years later we showed that this combination improved overall survival in 2021. This five-year update really extends these findings to ask the question of how long are these men living, how much longer are they living, what are their outcomes five years later and we show that for high-volume patients survival is extended by a median of three years from about four to seven years. That’s a phenomenal result for these patients, particularly with de novo or synchronous metastatic disease. The absolute survival benefit for the overall ARCHES trial was 13% additional, from about 53 to 66% chance of being alive at five years. This extension of survival at five years was notable for low-volume, high-volume patients, regardless of whether a patient had had prior docetaxel chemotherapy and regardless of geography, age, and other disease characteristics.

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