Daiichi reports Phase IIIb data for edoxaban in cancer-associated VTE

Daiichi Sankyo Co. Ltd. (Tokyo:4568) said once-daily oral edoxaban (DU-176b) met the primary endpoint of non-inferiority to standard of care (SOC) dalteparin in the incidence of a composite of recurrent venous thromboembolism (VTE) or major bleeding over 12 months in the Phase IIIb Hokusai-VTE CANCER trial in 1,050 patients with cancer-associated VTE (12.8% vs. 13.5%, p=0.006 for non-inferiority). Recurrent VTE occurred in 7.9% of patients in the edoxaban arm vs. 11.3% of patients in the SOC arm (p=0.09), and major bleeding occurred in 6.9% of patients in the edoxaban arm vs. 4% of patients in the SOC arm (p=0.04).

Edoxaban also met the secondary endpoint of non-inferiority to SOC in the 12-month event-free survival (EFS) rate (55% vs. 56.5%). The open-label, international trial enrolled patients with cancer who had acute symptomatic or incidental VTE. Data were presented at the American Society of Hematology meeting in Atlanta in December and published in the New England Journal of Medicine...