Denosumab Study Published in the Lancet Oncology Demonstrated Tumor Response for 86 Percent of Patients with Giant Cell Tumor of the Bone
THOUSAND OAKS, Calif. (February 9, 2010) – Amgen (NASDAQ: AMGN) issued the following statement on the publication of results online today by the Lancet Oncology. For a summary of the manuscript click here.
“Data from an open-label, Phase 2 study demonstrated a positive tumor response rate for denosumab in subjects with recurrent or unresectable giant cell tumor of bone; the study met all primary and secondary endpoints. Patients were administered 120 mg of denosumab subcutaneously once monthly with a loading dose at days 8 and 15 of month one (n=37). The primary endpoint was tumor response (elimination of greater than or equal to 90 percent of giant cells or no radiographic progression of the tumor). Of the 35 evaluable patients, 30 (86 percent) met tumor response criteria including some who had lung lesions. Among the patients assessed for tumor response, 26 (84 percent) reported clinical benefit including reports of reduction in pain requiring less analgesia and improvements in function and mobility (exploratory endpoint). Nine patients (29 percent) had evidence of bone repair (secondary endpoint). Suppression of bone turnover was seen in all patients (secondary endpoint).”
“In this study, denosumab appeared generally well-tolerated. The most frequent adverse events reported were pain in extremity (n=7 [19 percent]), back pain (n=4 [11 percent]), and headache (n=4 [11 percent]. Five patients had grade 3–5 adverse events, one of which was possibly treatment related. One death was reported, however this was not believed by the investigator to be related to treatment with denosumab.”
“This was the largest ever prospective study of unresectable giant cell tumor, a rare tumor of bone afflicting younger adults for whom few treatment options exist.”
About Giant Cell Tumor
Giant cell tumor of bone is a locally aggressive, benign tumor afflicting younger adults between the ages 20 to 40. Approximately 800 new giant cell tumor of bone cases are identified in the United States each year, which account for about one fifth of all benign primary bone tumors.
Most tumors occur in the long bones of the body, often around joints, but can spread to the lung. Patients can experience severe bone pain, swelling, loss of mobility if the tumor is close to a joint, and pathologic fracture. Giant cell tumors are slow growing, but have a 20 percent recurrence rate within three years of onset. When tumors recur, they become more likely to spread to other parts of the body. Currently, treatment options are very limited. The primary option is surgery, which may include joint replacement and amputation.
About Denosumab and Amgen's Research in Bone Biology
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). With more than 19,000 patients in trials across indications worldwide, the denosumab development program is the largest ever initiated by Amgen. This broad and deep development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-induced bone disease. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials, testing the drug for the reduction of SREs in breast cancer patients, for the amelioration of treatment-induced bone loss in patients with breast or prostate cancers, for the prevention of SREs due to the spread of cancer to the bone in patients with multiple myeloma or those suffering from a variety of solid tumors, and for its potential to delay bone metastases in prostate cancer.
Contact:
Amgen, Thousand Oaks
Lisa Rooney (805) 447-6437 (media)
Arvind Sood: (805) 447-1060 (investors)
