The final analysis of the COU-301 phase 3 clinical trial on Zytiga shows this drug has significant overall survival benefits. The full results were published in the prestigous scientific journal "Lancet Oncology."
Zytiga had improved overall survival in metastatic castration-resistant prostate cancer at a final analysis of the COU-301 double-blind, placebo-controlled phase III study.
The study had involved 1195 patients at 147 sites in 12 countries. Patients were eligible if they had metastatic castration-resistant prostate cancer progressing after docetaxel. Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate 1000 mg orally once daily plus prednisone 5 mg orally twice daily (n=797) or placebo plus prednisone (n=398). The primary endpoint was overall survival.
The following results were provided after a median follow-up of 20.2 months:
• Median overall survival (OS) for the Zytiga group was longer than in the placebo group (15.8 months vs. 11.2 months) giving an overall survival benefit of 4.6 months.
• Median time to PSA progression was 8.5 months in the Zytiga group vs. 6.6 months in the placebo group.
• Median radiological progression-free survival (PFS) was 5.6 months in the Zytiga group vs. 3.6 months in the placebo group.
• The proportion of patients who had a PSA response was greater in the Zytiga group (235 [30%] of 797 patients vs. 22 [5%] of 398.
The researchers concluded that this final analysis shows that abiraterone acetate prolongs overall survival in patients with metastatic castration-resistant prostate cancer who have progressed after docetaxel treatment, whilst no new safety issues were identified with the increased follow up period.
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