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Brought enzalutamide into first-line metastatic treatment, with an overall survival benefit confirmed in 2021.
ARCHES, trial NCT02677896 sponsored by Astellas and Pfizer and reported in 2019, brought enzalutamide into first-line treatment of metastatic hormone-sensitive prostate cancer, with an overall survival benefit confirmed in 2021. It randomised 1,150 men to androgen deprivation with enzalutamide or placebo, met its primary radiographic progression-free survival endpoint with a large effect, and later showed improved overall survival at the final analysis. OnCo links it to enzalutamide and to Andrew J. Armstrong, and the result was independently confirmed by ENZAMET and is consistent with TITAN for apalutamide, so the class effect is well replicated. Whether treatment intensity can be reduced in men who respond deeply is the open question the field has moved on to. Enzalutamide has its own page.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,150 enrolled.
Median not reached
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Radiographic progression-free survivalprimary | ADT + enzalutamide | 574 | Median not reached | 0.39 (0.3 to 0.5) | <0.001 | link |
| ADT + placebo | 576 | 19 months | ||||
| Overall survival | ADT + enzalutamide | - | Medians not reached at the final analysis | 0.66 (0.53 to 0.81) | - | link |
| ADT + placebo | - | - |
A second publication from the ARCHES trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT02677896 with the most citations, so it is the natural first reading for anyone following the ARCHES trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Astellas, Metastatic hormone-sensitive prostate cancer, Enzalutamide, Androgen deprivation & AR pathway inhibitors.
Shares A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Metastatic hormone-sensitive prostate cancer.
Shares A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Metastatic hormone-sensitive prostate cancer, Androgen deprivation & AR pathway inhibitors.
Shares Astellas, Metastatic hormone-sensitive prostate cancer, Enzalutamide, Androgen deprivation & AR pathway inhibitors.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Astellas, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Enzalutamide.
Shares Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors, Prostate cancer.
Shares Prostate cancer drugs in England: what NICE recommends, and what it refuses, Astellas, Enzalutamide, Androgen deprivation & AR pathway inhibitors.
Shares A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC, Prostate cancer drugs in England: what NICE recommends, and what it refuses, Androgen deprivation & AR pathway inhibitors, Prostate cancer.