The FINANCIAL — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) on June 19 announced the initiation of Hokusai-VTE Cancer, a multinational study which will investigate the efficacy and safety of edoxaban, an oral, once-daily selective factor Xa inhibitor, versus dalteparin for the treatment of VTE associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin) for whom long-term treatment with a low molecular weight heparin (LMWH) is intended.
The purpose of the study is to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of VTE recurrence or major bleeding following an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) event in patients with cancer. The recruitment has started, and approximately 1,000 patients are expected to be enrolled in the study at clinical sites across 13 countries, according to Daiichi Sankyo.
“VTE is a major cause of morbidity and mortality in patients with cancer, with an annual incidence that can be as high as 20 percent depending on the cancer type, background risk and time since diagnosis.2,3 Compared to those without cancer, patients with cancer who receive chemotherapy treatment have a 4- to 7-fold risk of developing VTE,” said Professor Gary Raskob, PhD, Dean, College of Public Health and Regents Professor, Epidemiology and Medicine, University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma.2,3,4 “This trial will allow us to gain further understanding of the efficacy and safety of edoxaban in comparison to current standards of care for these patients.”
“The initiation of the Hokusai-VTE Cancer study marks an important next step in our clinical research of edoxaban,” said Glenn Gormley, MD, PhD, Senior Executive Officer and Global Head of R&D, Daiichi Sankyo Company, Limited and Executive Chairman and President, Daiichi Sankyo, Inc. “The Hokusai-VTE Cancer study, along with the ongoing ENSURE-AF study, demonstrate the commitment of Daiichi Sankyo research and development to improve outcomes for patients at risk due to thrombosis.”
Edoxaban is currently marketed in Japan, the U.S., and Switzerland, and has also been recommended for approval in the EU by the European Committee for Medicinal Products for Human Use (CHMP).5,6,7,8 In other countries, regulatory review is ongoing.