On February 2, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that on February 1, 2018 in PST Amgen Inc. made an announcement regarding the top-line results from its Global Phase 3 D-CARE trial in which Daiichi Sankyo also participated (Press release, Daiichi Sankyo, FEB 1, 2018, View Source [SID1234523682]). Amgen Inc.’s D-CARE, placebo-controlled trial, evaluated AMG162 (generic name: denosumab) as adjuvant treatment for women with high-risk, early stage breast cancer receiving standard of care neoadjuvant or adjuvant cancer therapy.
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The trial did not meet its primary endpoint of bone metastasis-free survival. Adverse events observed in patients treated with denosumab were generally consistent with the known safety profile.
Detailed results will be submitted to a future medical conference or publication.
Daiichi Sankyo continues to contribute the field of medicine to patients and medical professionals.
About denosumab
Daiichi Sankyo licensed the rights to develop and market denosumab in Japan from Amgen Inc. (United States) in 2007, and began the Japanese sales of a 60 mg preparation as a therapeutic agent for osteoporosis under the product name PRALIA Subcutaneous Injection 60 mg Syringe in June 2013. PRALIA received approval for additional indication as a treatment for inhibition of the progression of bone erosion associated with rheumatoid arthritis in July 2017. In April 2012, Daiichi Sankyo began sales of a 120 mg preparation as a therapeutic agent for bone complications stemming from multiple myeloma and bone metastases from solid tumors under the product name RANMARK Subcutaneous Injection 120 mg. RANMARK received approval for additional indication as a treatment for giant cell tumor of bone in May 2014.
About the D-CARE Study
The D-CARE (Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence) study is an international, randomized, double-blind placebo-controlled trial of denosumab as adjuvant treatment for 4,509 women with early-stage breast cancer at high-risk of recurrence receiving standard of care neoadjuvant or adjuvant therapy. In this five year landmark study, patients were randomized to receive either subcutaneous denosumab 120mg or placebo every 3 or 4 weeks (Q3W or Q4W) for six months, followed by subcutaneous denosumab 120mg or placebo every three months for four and a half years, for a total treatment duration of five years (approximately 60 months). The primary endpoint for the study was bone metastasis-free survival and secondary endpoints included disease-free survival (DFS), DFS in the subset of post-menopausal women, overall survival and distant recurrence-free survival. Safety and tolerability were also evaluated.