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Enzalutamide safe, effective in hormone-naive prostate cancer
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Enzalutamide monotherapy appeared effective and well tolerated in men with various stages of hormone-naive prostate cancer, results of a phase 2 study showed.
“These findings provide a rationale for further investigation of clinical response and outcomes with enzalutamide in non-castrate men with prostate cancer,” the researchers wrote.
The ongoing open-label, single-arm trial — conducted across 12 European sites — is designed to assess the activity and safety of 160 mg/daily enzalutamide (Xtandi, Astellas Pharma) monotherapy up to 25 weeks in 67 men with hormone-naive prostate cancer. Study participants were aged older than 18 years, had non-castration levels of testosterone and PSA of 2 ng/mL or greater at screening, and an ECOG score of 0.
The proportion of patients with an 80% or more decline in PSA at week 25 served as the study’s primary endpoint.
By week 25, researchers reported an ≥80% decline in PSA in 62 men (92.5%; 95% CI, 86.2-98.38).
The most common mild treatment-emergent adverse events reported up to week 25 were gynaecomastia (n=24), fatigue (n=23), nipple pain (n=13) and hot flush (n=12). Grade ≥3 treatment-emergent adverse events were reported in nine patients. Those events included two cases of pneumonia and four cases of hypertension.
Disclosure:The study was funded by Astellas Pharma Inc. and Medivation Inc.
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