Amgen's denosumab misses in Phase III as adjuvant treatment for breast cancer

Amgen Inc. (NASDAQ:AMGN) and partner Daiichi Sankyo Co. Ltd. (Tokyo:4568) reported top-line data from the Phase III D-CARE trial in 4,509 breast cancer patients showing that subcutaneous denosumab (Prolia, Pralia, Ranmark, Xgeva, AMG 162) as adjuvant treatment missed the primary endpoint of improving bone metastasis-free survival vs. placebo. The partners said detailed data will be submitted for presentation at a future medical conference or publication.

The double-blind, international, five-year trial enrolled women with early stage breast cancer at high risk of recurrence who were receiving standard of care (SOC) neoadjuvant or adjuvant therapy. Secondary endpoints include overall survival (OS), distant recurrence-free survival, safety and disease-free survival (DFS)...