Daiichi Sankyo Company announced results from a prespecified subgroup analysis of 771 cancer patients enrolled in its Phase 3 Hokusai-VTW study evaluating the use of edoxaban. Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa.
Hokusai-VTE is a global, event-driven, randomized, double-blind, parallel-group clinical study that evaluated once-daily edoxaban in 8,292 patients with either acute symptomatic deep vein thrombosis (DVT), pulmonary embolism (PE), or both. The study was designed to reflect clinical practice using a flexible treatment duration of 3–12 months and initial use of heparin in both arms, in venous thromboembolism (VTE) patients, including those with cancer.
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.
Results from the prespecified subgroup analysis showed that patients treated with the edoxaban had a lower incidence of recurrent symptomatic venous VTE compared to warfarin (3.7% vs. 7.1%, respectively; HR, 0.53; 95% CI, 0.28–1.00). 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, 0.45–0.92).
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 with a lower incidence of recurrent symptomatic VTE compared to warfarin (3.2% vs. 3.5%, respectively) (HR, 0.89; 95% CI, 0.70–1.13; P<0.001 for non-inferiority) following initial use of heparin in both arms. 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, 0.71–0.94; P=0.004 for superiority) occurring during or within three days of interrupting or stopping study treatment.
Edoxaban is currently being studied for the treatment and prevention of recurrence of VTE in patients with DVT and/or PE, and for the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation, respectively.
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