Amgen announced primary results of a Phase 3 trial (‘147) demonstrating that XGEVA significantly increased bone metastasis-free survival for more than four months in men with castrate-resistant metastatic prostate cancer that has not yet spread to bone.
With effective therapies now in place for both early prostate cancer and advanced (castrate-resistant) prostate cancer, there is a gap in the treatment plan for those patients who are castrate-resistant but have not yet developed metastatic disease.
The data showed that XGEVA significantly improved median bone metastasis-free survival by 4.2 months, a risk reduction of 15% compared with placebo. XGEVA also significantly delayed the time to first bone metastases by 3.7 months compared with placebo and reduced the risk of bone metastases that were symptomatic by 33 percent.
In the ‘147 trial, adverse events and serious adverse events were relatively similar between the XGEVA and placebo arms. Hypocalcemia and osteonecrosis of the jaw (ONJ) were reported with increased frequencies in the XGEVA treated patients. Back pain was the most common adverse event reported in the XGEVA arm of the trial.
Study ‘147 was a randomized, placebo-controlled, multi-center Phase 3 study comparing the treatment effect of XGEVA to placebo in prolonging bone metastasis-free survival—a measure of the time that patients live without progressing to bone metastases—in 1,432 men with hormone-refractory (castrate-resistant) prostate cancer with rapidly-rising prostate-specific antigen (PSA) levels who had no bone metastases.
The endpoint of the trial was time to first occurrence of bone metastases or death from any cause with secondary endpoints including time to first occurrence of bone metastases (excluding death) and overall survival.
Results of the ‘147 study were presented at the American Urological Association (AUA) 2011 Annual Meeting.
Release Date: May 17, 2011
Filed Under: Drug Discovery