Astellas Pharma and Pfizer’s Xtandi shows long-term survival in prostate cancer

Astellas Pharma (ALPMY) and Pfizer (PFE) announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES study, reporting a five-year follow up of overall survival, or OS, benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer treated with Xtandi – enzalutamide -, an androgen receptor pathway inhibitor, plus androgen deprivation therapy vs. placebo plus ADT. These data will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago. In patients with high-volume disease a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease; patients who had previously received docetaxel therapy and those who had not received prior docetaxel therapy. The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified. These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group. OS at 96 months was 50% with Xtandi and 40% for NSAA; progression-free survival also favored Xtandi over NSAA. Mean duration of treatment was longer for Xtandi than NSAA, with 33% remaining on Xtandi and 88% of these patients remained at the full dose of 160 mg.

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