UPDATE 1-Amgen bone drug meets goal of late-stage study

* Denosumab non-inferior to Zometa in cancer patients

* Not statistically significant for superiority

* Serious adverse events similar

By Bill Berkrot

NEW YORK, Aug 3 (Reuters) - Amgen Inc's (AMGN.O) closely watched experimental osteoporosis drug denosumab met the primary goal of delaying time to fracture or other skeletal- related events in patients with advanced cancer, as well as another leading treatment, the company said on Monday.

Patients treated with denosumab experienced a similar time to first skeletal-related event (SRE), defined as fracture, radiation to bone, surgery to bone, or spinal cord compression, compared with those receiving Novartis AG's (NOVN.VX) Zometa, which was the main goal of the non-inferiority study.

The delay in time to first SRE associated with denosumab was greater than with Zometa, but not enough to reach statistically significant superiority, which had been a secondary goal of the trial, the world's largest biotechnology company said.

Time to first-and-subsequent SRE was also numerically greater with denosumab, but not enough to claim statistical superiority compared with Zometa, Amgen said.

The Phase III trial was the second of a series of three planned head-to-head study's of denosumab in patients whose advanced cancer has spread to the bone. The spread of tumors to the bone is a serious concern for many patients with advanced cancer.

The latest study tested 1,776 advanced cancer patients with solid tumors, not including breast and prostate cancer, or multiple myeloma.

The Amgen drug, widely considered the most important growth driver in the company's developmental pipeline, last month had successful data versus Zometa in breast cancer patients with bone metastases. The third study involves patients with advanced prostate cancer.

"We are extremely pleased with these results, which continue to demonstrate that inhibiting RANK Ligand with denosumab provides a clinically meaningful benefit for advanced cancer patients with solid tumors that have metastasized to the bone, and to patients with multiple myeloma -- both groups who routinely suffer SREs," Amgen's research chief Roger Perlmutter said in a statement.

Full details of the study will be presented at a future medical meeting, the company said.

Amgen is awaiting U.S. approval of denosumab as a treatment for post-menopausal osteoporosis. Further approval as a treatment to avert bone damage in cancer patients would significantly add to future sales.

Patients in the study received either denosumab subcutaneously every four weeks or a 15-minute intravenous infusion of Zometa every four weeks.

The incidence of adverse events and serious adverse events was consistent with what has previously been reported for the two medicines, the company said.

Rates of osteonecrosis, or deterioration, of the jaw were infrequent in both treatment groups -- 10 patients on denosumab versus 11 patients on Zometa.

Overall survival and the time to cancer progression was also similar in both treatment groups, Amgen said. (Reporting by Bill Berkrot; editing by Andre Grenon)