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Astellas and Pfizer's XTANDI™ (Enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

On May 22, 2025, Astellas Pharma Inc. And Pfizer Inc. Announced five-year follow-up results from the global Phase 3 ARCHES trial of XTANDI in metastatic hormone-sensitive prostate cancer across multiple regions including the U.S. And Asia-Pacific.
This announcement follows a 2009 global agreement for joint development and commercialization of XTANDI, driven by the goal to improve survival in prostate cancer patients, amid uncertainties in clinical outcomes and regulatory approvals.
The ARCHES trial enrolled 1,150 men randomized to XTANDI plus androgen deprivation therapy or placebo plus ADT and showed a 30% reduction in risk of death, with 66% of XTANDI-treated patients surviving five years versus 53% with placebo.
Key findings include a 36-month extension in median overall survival for individuals with high-volume metastatic hormone-sensitive prostate cancer treated with XTANDI plus ADT, reflected by a hazard ratio of 0.70. Similar survival advantages were observed across other patient groups, and the safety profile remained consistent with no new adverse events reported over five years. These results will be disclosed at the forthcoming ASCO 2025 meeting.
These findings reinforce XTANDI plus ADT as the standard of care for metastatic hormone-sensitive prostate cancer, although ongoing studies and regulatory reviews must address risks, efficacy, and commercial factors influencing its future use globally.

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Astellas and Pfizer's XTANDI™ (enzalutamide) Shows Long-Term Overall Survival in Metastatic Hormone-Sensitive Prostate Cancer

Five-year follow-up data from the Phase 3 ARCHES trial shows XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) reduces risk of death by 30%After a median follow-up of 61.4 months, treatment with XTANDI (enzalutamide) plus ADT was associated with a 66%…

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FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer

(MedPage Today) -- An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer...

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Clinical Trials Arena

Astellas and Pfizer’s Xtandi combo reduces death risk in prostate cancer trial

Astellas and Pfizer's Xtandi plus ADT showed a decrease in mortality risk in a metastatic hormone-sensitive prostate cancer (mHSPC) trial.The post Astellas and Pfizer’s Xtandi combo reduces death risk in prostate cancer trial appeared first on Clinical Trials Arena.

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