BMS, Pfizer halt Apixaban Phase 3 APPRAISE-2 trial

BMS and Pfizer said that the study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC).

There was clear evidence of a clinically important increase in bleeding among patients randomised to Apixaban, which was not offset by clinically meaningful reductions in ischemic events.

The APPRAISE-2 Trial, one of nine clinical trials evaluating Apixaban in patients at risk of ischemic events, was designed to include approximately 10,800 patients with a recent ACS randomised to Apixaban 5mg twice daily or placebo.

BMS and Pfizer have informed the APPRAISE-2 investigators, ethics review boards and regulatory health authorities of the decision to stop the study.

BMS Global Development and Medical Affairs senior vice president Brian Daniels said that they remain committed to the development of Apixaban in other patient populations.

"We are focused on the rolling submission of data for the prevention of stroke in patients with atrial fibrillation who are expected or demonstrated to be unsuitable for treatment with warfarin to the US Food and Drug Administration and the application to the European Medicines Agency for venous thromboembolism (VTE) prevention," Daniels said.

APPRAISE-2 Steering Committee co-chair Robert Harrington said that their recommendation to discontinue APPRAISE-2 concerns only the population of high-risk ACS patients receiving anti-platelet therapy enrolled in APPRAISE-2.

"Recent Phase 3 clinical trials of Apixaban have demonstrated promising results in patients with VTE and atrial fibrillation," Harrington said.

BMS and Pfizer stated that based on the APPRAISE-2 recommendation, the DMC for APPRAISE Japan, a Phase 2 study in ACS patients, has also recommended discontinuation for APPRAISE Japan.