BRIEF—Savaysa/Lixiana meets endpoint in cancer-associated VTE trial

The Hokusai-VTE CANCER study evaluating oral edoxaban - known by the brand names Savaysa in the USA and Lixiana elsewhere – has met the primary endpoint of non-inferior to subcutaneous injectable low molecular weight heparin (LMWH) dalteparin for cancer-associated venous thromboembolism (VTE) or major bleeding.

Japan’s Daiichi Sankyo (TYO: 4568) has presented the results of the Phase IIIb study during the late-breaker session at the American Society of Hematology (ASH) Annual Meeting and they were simultaneously published in the New England Journal of Medicine.

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.

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.

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.

VTE includes both deep vein thrombosis and pulmonary embolism and is the second leading cause of death in cancer patients receiving chemotherapy.

Hans Lanz, vice president, global medical affairs, Daiichi Sankyo, said: “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.”