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Japan : Once-Daily, Oral LIXIANA (edoxaban) Met Primary Endpoint in Investigational Hokusai-VTE CANCER Study.

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced results from the Hokusai-VTE CANCER study evaluating oral edoxaban (known by the brand names LIXIANA outside the U.S. and SAVAYSA in the U.S.), and found that edoxaban is non-inferior to subcutaneous injectable LMWH dalteparin for the treatment of cancer-associated VTE and major bleeding.2,3 The results of the study were simultaneously published in the New England Journal of Medicine (NEJM) and presented during the late-breaker session at the 59th American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.

Hokusai-VTE CANCER is the first study with a direct oral anticoagulant (DOAC), edoxaban, to meet pre-specified non-inferiority criteria versus the standard of care dalteparin in this patient population.2,3 The study met the primary objective of non-inferiority of edoxaban for the composite outcome of first recurrent VTE or ISTH-defined major bleeding during a 12-month study period, which occurred in 67 of 522 patients (12.8%) in the edoxaban group compared with 71 of 524 patients (13.5%) in the dalteparin group (hazard ratio with edoxaban, 0.97; 95% CI, 0.70 to 1.36; P = 0.006 for non-inferiority) for a risk difference (edoxaban minus dalteparin) of -0.7% (95% CI, -4.8 to 3.4).2,3 The difference in risk for recurrent VTE was -3.4% (95% CI, -7.0 to 0.2) whereas the corresponding difference in risk for major bleeding was 2.9% (95% CI, 0.1 to 5.6).3 The frequencies of severe major bleeding events at presentation (categories 3 and 4) were similar during treatment with edoxaban or dalteparin (12 patients in each group, respectively).2,3 There was no fatal bleed in the edoxaban group versus two fatal bleedings in the dalteparin arm.3

The study also met the secondary outcome of event-free survival (free of recurrent VTE, major bleeds or death) at 12 months, and rates were similar between edoxaban and dalteparin (55.0% and 56.5%, respectively).2,3 The trial was a PROBE design study and included a broad spectrum of patients (n=1,050) with primarily active cancer (98%): 53% of which had metastatic cancer and 72% of which were receiving cancer therapy at randomisation.2,3 This is the largest prospectively randomised clinical trial to have studied the benefit risk of DOACs in cancer patients versus the current injectable standard of care, dalteparin. Hokusai-VTE CANCER is the first study to demonstrate that a DOAC, edoxaban, is non-inferior to the standard of care, injectable LMWH (dalteparin), in this population.2,3 Cancer patients have a significantly increased risk of VTE, and are a high-risk population since 82% of patients have one or more pre-specified bleeding risk factors, said co-principal study investigator Professor Harry Bller, from the Department of Vascular Medicine at Academic Medical Center, Amsterdam, The Netherlands. We saw a lower rate of recurrent VTE with edoxaban compared to dalteparin over the one-year study period. In addition, in the edoxaban arm, we saw no bleeding fatalities and similar severity of clinical presentation of major bleeding events compared to dalteparin. The risk for VTE persists beyond six months for cancer patients, therefore, the study duration of 12 months enabled the evaluation of edoxaban over a longer time period.

VTE includes both deep vein thrombosis (DVT) and pulmonary embolism (PE) and is the second leading cause of death in cancer patients receiving chemotherapy.4 Current guidelines recommend LMWH for at least six months as the standard of care in cancer patients,5,6,7 and currently there is poor adherence to VTE cancer treatment guidelines due to the requirement for daily injections. The treatment of cancer-associated VTE is challenging because these patients are at increased risk of both recurrent VTE and major bleeding.2 The occurrence of VTE increases the risk of death 2-6-fold in cancer patients4 and can interrupt cancer treatment.8 The use of an oral anticoagulant that alleviates the burdens associated with a daily injectable drug, without loss of clinical benefit, would represent an advance for cancer patients with VTE, said Hans J. Lanz, MD, Vice President, Global Medical Affairs, Daiichi Sankyo. The data will continue to add to the growing body of knowledge in the Edoxaban Clinical Research Programme, which provides key insights into the potential effects of edoxaban in VTE and AF patients.

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Publication:Mena Report
Date:Dec 14, 2017
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