Astellas’ Xtandi “significantly improves” progression-free survival in advanced hormone-sensitive prostate cancer
Japanese pharma firm Astellas has lifted the curtain on new data for its androgen receptor signalling inhibitor Xtandi (enzalutamide), when combined with androgen deprivation therapy (ADT), in the treatment of male patients with metastatic hormone-sensitive prostate cancer (mHSPC).
It was found that the combination met its primary endpoint in Phase 3 trials, significantly reducing the risk of radiographic progression or death by 61% compared to the combination of ADT and placebo.
Additionally, the combo met its secondary endpoint of reduction in risk of prostate specific antigen (PSA) progression and reduction in risk of starting a new antineoplastic therapy compared to placebo plus ADT.
However, median time to a radiographic progression-free survival (rPFS) event was not reached in the Xtandi plus ADT arm, while in the placebo plus ADT arm this was recorded as 19.4 months. Overall survival data were also not ready at the time of analysis.
Dr Andrew Armstrong, Professor of Medicine, Surgery, Pharmacology and Cancer Biology, and Director of Research in the Duke Cancer Institute’s Centre for Prostate and Urologic Cancers, remarked on the findings: “The ARCHES trial demonstrated that enzalutamide plus standard hormonal therapy delayed disease progression and if approved has the potential to be an important treatment option for men with prostate cancer that has spread but has not yet become hormone resistant.”
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