Background: The CPX-351 liposomal formulation delivers a synergistic 5:1 molar ratio of cytarabine (C) and daunorubicin (D) preferentially to leukemia cells. CPX-351 has demonstrated significantly improved overall survival (OS) versus 7+3 in a randomized, open-label, phase III study in patients (pts) aged 60-75 years with newly diagnosed, high-risk AML. In contrast to 7+3, which includes C continuous infusion, CPX-351 is administered as a 90-minute infusion and has the potential to be given in the outpatient setting. The current analysis of the phase III trial assessed the setting of consolidation therapy. Methods: Pts were randomized 1:1 to 1-2 induction cycles of CPX-351 or 7+3; pts with complete remission (CR) or CR with incomplete platelet or neutrophil recovery (CRi) could receive up to 2 consolidation cycles (CPX-351: 65 u/m² [C 65 mg/m² + D 28.6 mg/m²] on Days 1 and 3; 7+3: C 100 mg/m²/day x 5 days + D 60 mg/m² on Days 1 and 2). Site of administration was not protocol defined. Results: Few pts received induction as outpatient therapy (CPX-351 n = 3/153 and 7+3 n = 1/151 in each cycle). 49/153 CPX-351 pts and 32/151 7+3 pts received consolidation, with a substantial proportion of pts receiving CPX-351 as outpatients (consolidation 1: 51%; consolidation 2: 61%). CPX-351 consolidation was associated with substantial improvement in median OS versus 7+3 irrespective of inpatient/outpatient status (Table). Median OS was not diminished with CPX-351 administration in the outpatient versus inpatient setting (consolidation 1: 25.43 and 14.72, respectively; consolidation 2: 26.32 and not reached). Conclusions: Some pts can successfully receive CPX-351 consolidation as outpatients without diminished efficacy, potentially reducing hospitalizations associated with treatment administration. Clinical trial information: NCT01696084