Daiichi Sankyo Company, Limited has reported results of a prespecified subgroup analysis of 771 cancer patients enrolled in the phase III Hokusai-VTE study. Patients with either a history of cancer (n=563) or with active cancer (n=208) treated with the once-daily factor Xa-inhibitor edoxaban had a numerically lower incidence of recurrent symptomatic venous thromboembolism (VTE) compared to warfarin (3.7% vs. 7.1%, respectively; hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.28 to 1.00).

Once-daily edoxaban also had a lower incidence of clinically relevant bleeding (major or non-major) compared to warfarin in cancer patients (12.4% vs. 18.8%, respectively; HR, 0.64; 95% CI, 0.45 to 0.92). 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 III 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 Centre 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 per cent depending on the cancer type, background risk, and time since diagnosis,” said Harry Büller, MD, PhD, Professor of Internal Medicine, chairman of the Department of Vascular Medicine at the Academic Medical Centre 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.”

Hokusai-VTE was a global, event-driven, randomized, double-blind, parallel-group phase III clinical study involving 8,292 patients in 439 clinical sites across 37 countries to evaluate once-daily edoxaban in patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The Hokusai-VTE study was designed to reflect clinical practice using a flexible treatment duration of three to 12 months, including initial use of heparin, the proven global standard of care, in both arms, in a broad spectrum of VTE patients, including those with cancer.

The full results were presented at the ESC Congress 2013 in Amsterdam and published in the New England Journal of Medicine, demonstrating that edoxaban met the primary efficacy endpoint of non-inferiority, with a numerically lower incidence of recurrent symptomatic VTE compared to warfarin (3.2% vs. 3.5%, respectively) (HR, 0.89; 95% CI, 0.70 to 1.13; p<0.001 for non-inferiority)following initial use of heparin in both arms. Recurrent symptomatic VTE was defined as the composite of recurrent symptomatic DVT, non-fatal symptomatic PE and fatal PE in patients during the 12-month study period. Once-daily edoxaban was also found to be superior to warfarin for the pre-specified principal safety outcome of clinically relevant bleeding (8.5% vs. 10.3%, respectively) (HR, 0.81; 95% CI, 0.71 to 0.94; p=0.004 for superiority) occurring during or within three days of interrupting or stopping study treatment.

The Hokusai-VTE study included a prespecified subgroup analysis of patients with either a history of cancer (n=563) or with active cancer (n=208) if long term low molecular weight heparin (LMWH) was not planned due to availability, physician judgment or patient preference. The trial excluded patients with active cancer for whom long term treatment with LMWH was anticipated.

VTE is an umbrella term for two conditions, DVT and PE. DVT is a blood clot found anywhere in the deep veins of the legs, while PE occurs when part of a clot detaches and lodges in the pulmonary arteries, causing a potentially fatal condition.

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