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Amgen XGEVA Phase 3 trial meets primary endpoint

PBR Staff Writer Published 18 May 2011

Amgen's XGEVA (denosumab) Phase 3 trial (147) has met primary endpoint by increasing bone metastasis-free survival for more than four months in men with advanced (castrate-resistant) metastatic prostate cancer that has not yet spread to bone.

XGEVA, a RANK Ligand inhibitor approved by the US Food and Drug Administration (FDA), is indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors.

XGEVA prevents RANK Ligand from activating its receptor, RANK, on the surface of osteoclasts, thereby decreasing bone destruction.

Study '147 is 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 at baseline.

The primary 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.

XGEVA is also being investigated for the potential use to delay the onset of bone metastasis in adjuvant breast cancer.

Amgen has submitted marketing applications for XGEVA in the EU, Australia, and Switzerland for the prevention of SREs.

In Japan, Amgen is working with its licensing partner, Daiichi Sankyo and a marketing application was submitted.