Study Design

A Phase 3 study established the benefit of single-agent MYLOTARG vs BSC in older adults with newly diagnosed AML1
AML-19 was a Phase 3, multicenter, randomized, open-label study comparing MYLOTARG to BSC in 237 patients with newly diagnosed AML1
PRIMARY ENDPOINT: Overall Survival
  • Patients were greater than 75 years of age, or 61 to 75 years of age with a World Health Organization performance status (WHO PS) greater than 2 or were unwilling to receive intensive chemotherapy
  • Secondary endpoints were disease-free survival (DFS) and complete remission (CR) or CR with incomplete recovery of peripheral blood counts (CRi)
AML=acute myeloid leukemia; BSC=best supportive care; CR=complete remission; D=day; PR=partial response; SD=stable disease; WBC=white blood cell.
REFERENCES
1. MYLOTARG Prescribing Information. New York, NY: Pfizer Inc.
2. Amadori S, Suciu S, Selleslag D, et al. Gemtuzumab ozogamicin versus best supportive care in older patients with newly diagnosed acute myeloid leukemia unsuitable for intensive chemotherapy: results of the randomized phase III EORTC-GIMEMA AML-19 trial. J Clin Oncol. 2016;34(9):972-979.