Phase II trial of CPX-351 (cytarabine:daunorubicin) liposome injection in patients with acute myeloid leukemia >60 years of age who have not been treated with intensive chemotherapy.

Abstract

7044 Background: This study enrolled older patients without age limitation to intensive chemotherapy with CPX 351 allowing for prior treatment with low intensity regimens for MDS or AML. Methods: 30 patients aged ≥65yrs with diagnosed AML received up to two induction cycles and consolidation cycles of CPX-351 as a first intensive therapy. The primary efficacy endpoint was overall survival and the primary safety endpoint was 30-day mortality. Secondary efficacy endpoints included response rate and duration, and assessment of the relationship between cognitive function and treatment outcome. Although the primary efficacy endpoint data is pending, these interim results describe promising primary safety and efficacy endpoint results. Of the 30 patients enrolled, 10 patients (33.3%) were ≥75yrs old, 13 patients (43.3%) had had previous hematologic malignancies, 17 patients (56.6%) had adverse ELN risk stratification, and 16 patients (53.3%) had failed to respond to previous non-intensive treatments. In addition, all patients had an average of 2.1 co-morbid medical conditions. Results: 14 patients (47%) achieved best response criteria, with 12 patients (40.0%) achieving complete remission (CR) and 2 patients (6.6%) achieving complete remission with incomplete platelet or neutrophil recovery (CRi). 6 patients (20%) had a morphologic leukemia free state with pancytopenia and 10 patients had persistent disease. 8 patients (26.6%) went to stem cell transplant. 2 patients (6.6%) died within 30-days. Although final analysis on adverse events data is pending, 6 patients (20%) experienced a Grade 2 decrease in left ventricular ejection fraction (LVEF) at the end of first induction. Conclusions: These results suggest that in elderly AML patients regardless of age and prior treatment with non-intensive chemotherapy can be treated safely with CPX 351 with low 30 day mortality. CR in these patients is 40% with 26% going forward to stem cell transplant. Complete data will be assessed for OS and rate of MRD positivity. The relationship of cognitive and social factors to outcome will also be addressed.