The first three anti-thrombotic drugs clinical trials reached the primary end point

The first three anti-thrombotic drugs clinical trials reached the primary end point

December 15, 2017 Source: WuXi PharmaTech

Recently, Daiichi Sankyo Pharmaceutical Co., Ltd. announced that the company's edoxaban reached the primary end point of the trial in clinical phase 3b trials for the treatment of venous thromboembolism (VTE) in cancer patients. Oral edoxaban achieves non-inferiority in the treatment of tumor-associated VTE or major bleeding compared to subcutaneously injected low molecular weight heparin therapy. The trial results were also published in the New England Journal of Medicine.

VTE is a major complication in cancer patients, including deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE is one of the leading causes of death in cancer patients, and up to 20% of cancer patients may die each year because of VTE. Cancer patients carry multiple risk factors for VTE, and receiving chemotherapy increases the risk of VTE. Treating VTE in cancer patients is a serious challenge as these patients have an increased risk of major bleeding while increasing the risk of VTE. Conventional anticoagulant drugs may increase the risk of bleeding in patients while reducing thrombosis in patients.

Edoxaban, developed by First Sankyo Pharmaceutical Co., is an oral factor Xa inhibitor. Coagulation factor Xa is one of the important factors in the blood coagulation process, and its inhibition can make blood less likely to coagulate. Edoxaban has been listed in many countries around the world, including a number of European countries including the United States, South Korea, Hong Kong, the United Kingdom and Germany.

In this clinical phase 3b trial called Hokusai-VTE CANCER, 1,050 cancer patients participated in the trial, of which 53% had metastases and 72% received cancer therapy at the start of the trial. These patients were randomized into two groups, each receiving edoxaban or dalteparin. Patients were followed for 12 months to detect the number of recurrent VTE and major bleeding. The trial data showed that the total incidence of repetitive VTE and major bleeding in the edoxaban group (12.8%) was non-inferior to the daloflavin group (13.5%) (hazard ratio 0.97, non-inferiority P value 0.006) ). At the same time, the trial reached its secondary end point, and the proportion of patients who did not develop repetitive VTE, severe bleeding, or death after 12 months was very similar in the edoxaban and dalnutramine groups (55.0% and 56.5%, respectively).

â–² Professor Harry Buller (Source: Academic Medical Center)

“The risk of VTE is significantly elevated in cancer patients, and because 82% of them carry one or more risk factors for bleeding, they are a high-risk patient group,” said co-leader of the trial, Amsterdam Academic Medical Center, The Netherlands Professor Harry Buller of the Department of Vascular Medicine at the (Academic Medical Center) said: "We saw a lower rate of repetitive VTE in the edoxaban group during the one-year study. And there was no death from bleeding in the edoxaban group. The clinical severity of major bleeding events is comparable to that of the heparinase group."

Dr. Hans J. Lanz, Vice President of Global Medical Affairs at First Triad, added: "The results of the Hokusai-VTE CANCER trial will continue to enrich our understanding of the role of edoxaban in patients with VTE."

Reference materials:

[1] Once-Daily, Oral SAVAYSA® (edoxaban) Met Primary Endpoint in Investigational Hokusai-VTE CANCER Study

[2] Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism

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