Astellas and Pfizer have reported five-year follow-up outcomes from the open-label extension of the randomised Phase III ARCHES trial.
The study indicated that Xtandi (enzalutamide), combined with androgen deprivation therapy (ADT), showed a 30% decrease in the mortality risk in men with metastatic hormone-sensitive prostate cancer (mHSPC).
Patients treated with the combination therapy showed a reduction against those receiving placebo plus ADT.
The findings offer a longer-term perspective on the overall survival (OS) benefits of the androgen receptor pathway inhibitor (ARPI), Xtandi.
Subjects with high-volume disease experienced a 36-month improvement in median OS.
The study also assessed various clinically relevant subgroups, including those with low-volume disease and those previously treated with docetaxel, all demonstrating consistent survival improvements.
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By GlobalDataAdditionally, the occurrence of treatment-emergent adverse events in the five-year follow-up aligned with previous analyses from the ARCHES trial, without any new safety concerns identified.
The placebo-controlled, multinational, double-blind trial enrolled 1,150 participants across sites in South America, Canada, Europe, the Asia-Pacific region, and the US.
Its primary endpoint was radiographic progression-free survival (rPFS), with OS as a key secondary endpoint. The post hoc five-year analysis aimed to provide a comprehensive view of long-term survival benefits.
Astellas’ medical affairs head and executive vice-president Shontelle Dodson said: “The survival benefits of intervention with Xtandi in advanced prostate cancer are well-recognised.
“The collective – and growing – body of data for Xtandi continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that Xtandi is changing the trajectory of those living with the disease.”
Xtandi has been approved for use in more than 90 nations, including the European Union, Japan, and the US.
Astellas is responsible for the global manufacturing and commercialisation outside the US while both companies jointly market the therapy within the US.
Last October, Pfizer announced positive top-line data from the Phase III TALAPRO-2 study evaluating the combination of Talzenna (talazoparib) and Xtandi in patients with metastatic castration-resistant prostate cancer (mCRPC).
