Daiichi Sankyo presents subgroup analysis of Hokusai-VTE study at ASH annual meeting

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase 3 Hokusai-VTE study. Patients with either a history of cancer. These findings are consistent with the results from the wider study population of 8,292 patients, which found once-daily edoxaban met the primary efficacy endpoint of non-inferiority for the treatment and prevention of VTE and superiority for the pre-specified principal safety outcome of clinically relevant bleeding compared to warfarin. The data from this subgroup analysis of the phase 3 Hokusai-VTE study were presented at the 2013 American Society of Hematology Annual Meeting and Exposition in New Orleans.

"VTE is a common complication in cancer patients, and cancer patients with VTE are at higher risk of recurrence, so we are pleased that the subgroup analysis found that patients treated with edoxaban had a numerically lower incidence of VTE recurrence and clinically relevant bleeding compared to warfarin," said Gary Raskob, PhD, Dean of the College of Public Health, Professor, Epidemiology and Medicine University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma and member of the Hokusai-VTE steering committee. "These findings provide us with insights about the potential benefit of edoxaban administered once-daily compared to warfarin for the treatment and prevention of recurrent symptomatic VTE in cancer patients."

"VTE is a major cause of morbidity and mortality in patients with cancer, with an annual incidence that can be as high as 20% depending on the cancer type, background risk, and time since diagnosis," said Harry Buller, MD, PhD, Professor of Internal Medicine, Chairman of the Department of Vascular Medicine at the Academic Medical Center in Amsterdam, The Netherlands and Chairman of the Hokusai-VTE steering committee. "A promising finding was the sizeable reduction in recurrent symptomatic VTE among cancer patients who were treated with once-daily edoxaban."

In the subset of 208 patients with active cancer, once-daily edoxaban had a rate of VTE recurrence of 3.7% compared to 7.1% for warfarin (HR, 0.55; 95% CI, 0.16 to 1.85) and an incidence of clinically relevant bleeding of 18.3% compared to 25.3% for warfarin (HR, 0.72; 95% CI, 0.40 to 1.30).

"Our global Hokusai-VTE study of once-daily edoxaban included a broad range of patients and we recognize that VTE can be a common complication of cancer, so it´s not surprising to see that 9.3% of patients enrolled had active cancer or a history of cancer," said Glenn Gormley, MD, PhD, Senior Executive Officer and Global Head of Research and Development, Daiichi Sankyo Co., Ltd. and President and CEO of Daiichi Sankyo, Inc. in the United States. "Daiichi Sankyo is committed to help clinicians understand potential treatment strategies for diverse patient populations with VTE."