Amgen Bone Drug Helped More Than Zometa In Breast Cancer Study
Breast cancer patients taking denosumab had an 18 percent lower risk of developing a first fracture or requiring radiation treatment or surgery than those who received Zometa, the current standard treatment for such patients, Thousand Oaks, California- based Amgen said today in a statement.
A U.S. advisory panel last month recommended approval of denosumab for women with osteoporosis and men undergoing prostate cancer treatment. The study may help strengthen Amgens case for use of denosumab in cancer patients, an indication that could help the product achieve $1 billion in annual sales, according to Bret Holley, a New York-based analyst at Oppenheimer & Co.
The data “suggests superiority to market leader Zometa with improved safety,” Jim Birchenough, an analyst at Barclays Group in New York, wrote in a Sept. 21 note to investors. The data also suggested “no tumor promotion in women” with breast cancer, he said.
The company-sponsored study is from one of three late-stage studies that are being presented this week at the European Cancer Organization and European Society for Medical Oncology conference in Berlin.
Stalling Fractures
The 34-month trial followed 2,046 breast cancer patients whose disease had spread to the bone, a progression that occurs in as many as 75 percent of breast cancer patients, Amgen said. A tumor that spreads and settles in a patients bone can cause complications such as fractures, compression of the spinal cord, and the need for radiation or surgical treatment.
The study measured the time from treatment with either denosumab or Zometa to a patients first complication from bone metastasis. The median time for the first fracture or complication for patients taking Zometa was 26.5 months. The median time for a first fracture or complication was not reached for denosumab and could not be estimated, according to a summary of the data from the European cancer meeting.
The rate of all types of side effects was about the same for denosumab as Zometa. Kidney-related problems occurred in 4.9 percent of denosumab patients compared with 8.5 percent of patients on Zometa.
Comparable to Zometa
In a study reported yesterday, patients with advanced tumors found that denosumab delayed the development of fractures and other complications about as well as Zometa. The study looked at patients with solid tumors other than breast or prostate cancer, and those with multiple myeloma, a form of blood cancer. Patients on denosumab had a median time of 20.6 months before experiencing a fracture or complication, compared with 16.3 months for people on Zometa, Amgen said.
Denosumab is given as a monthly shot, while Zometa is administered through an intravenous infusion every three to four weeks. The more convenient dosing may give denosumab an edge in the market for treatments for patients whose cancer has spread to the bone, Holley said in a Sept. 21 note to investors.