Results from a randomized phase II study presented Saturday at the American Society of Clinical Oncology (ASCO) annual meeting indicates there might be a new drug on the horizon for men with advanced prostate cancer. OncoGenex Pharmaceuticals drug known as OGX-011 extended the survival of patients with advanced prostate cancer by almost seven months in a small phase II study.
The phase II study enrolled 82 men with advanced prostate cancer who had not yet begun chemotherapy treatment. The patients were randomized to receive either a combination of OGX-011 plus Taxotere or Taxotere alone.
The median overall survival for the men treated with OGX-011 plus Taxotere was 23.8 months compared to 16.9 months for men treated with Taxotere alone — an improvement in survival of 6.9 months favoring the experimental arm of the study. In this study, treatment with OGX-011 reduced the risk of death by 39% compared to treatment with Taxotere alone.
Being a phase II study wasn’t designed to prove the drug’s ability to prolong survival, its goal was to evaluate toxicity and dosing. Even though the survival benefit seen in the OGX-011 study was not statistically significant we should remember that Taxotere was approved in 2004 based on a 2.4-month survival advantage in advanced prostate cancer. If a phase III trial is conducted a similar results are demonstrated, the FDA is bound to experience a political football not different from the issues surrounding the initial FDA evaluation of Provenge.
OGX-011 prolonged survival despite having little or no measurable effect on tumor progression compared to Taxotere alone. Fifty-eight percent of men tr