Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced the results of the Phase 3 AMPLIFY-EXT trial, which evaluated treatment with ELIQUIS ® (apixaban) over a one-year period compared to placebo for the prevention of recurrent venous thromboembolism (VTE) in 2,486 patients who had already completed 6 to 12 months of anticoagulation treatment for VTE, including deep vein thrombosis (DVT) or pulmonary embolism (PE). In the trial, extended treatment with ELIQUIS 2.5 mg and 5 mg twice daily, demonstrated superiority versus placebo in the reduction of the composite endpoint of symptomatic, recurrent VTE and death from any cause (11.6% in the placebo group, compared with 3.8% and 4.2% in the ELIQUIS 2.5 mg and 5 mg groups, respectively, P<0.001), the primary efficacy outcome of the trial.
ELIQUIS also was superior to placebo for the predefined secondary efficacy outcome of recurrent VTE and VTE-related death (8.8% in the placebo group, compared with 1.7% in both the ELIQUIS 2.5 mg and 5 mg groups). Both of these endpoints, the primary and secondary efficacy outcomes, were statistically significant (p<0.001).
The rate of the primary safety outcome of major bleeding was comparable across treatment groups (0.2 % for ELIQUIS 2.5 mg; 0.1 % for ELIQUIS 5 mg and 0.5% for placebo). The rate of the composite of major bleeding and clinically relevant non-major bleeding for the 5 mg treatment group (4.3%) was higher versus the placebo group (2.7%), while the rate for the 2.5 mg treatment group (3.2%) was similar to the placebo group. The findings were published online today in The New England Journal of Medicine and announced at a press briefing during the 54th Annual Meeting of the American Society of Hematology (ASH).
“Up to 10 percent of patients will experience a recurrent venous thromboembolism event after completing the currently recommended six-to-twelve-month treatment period, suggesting the need for additional prophylaxis,” said Dr. Giancarlo Agnelli, professor of internal medicine, University of Perugia, Italy; director of the Department of Internal and Cardiovascular Medicine and Stroke-Unit, University Hospital, Perugia, Italy; and lead investigator of the study. “In the AMPLIFY-EXT trial, which added an additional year of treatment, ELIQUIS reduced the composite risk of recurrent venous thromboembolism and total mortality without an increase in major bleeding versus placebo.”