A multicenter retrospective study compared clinical outcomes with liposomal daunorubicin/cytarabine (CPX-351) versus hypomethylating agent + venetoclax (HMA + VEN) as upfront treatment for patients with newly diagnosed acute myeloid leukemia (AML).
The study identified patients treated with CPX-351 or HMA + VEN as frontline AML therapy at 4 major US academic medical centers. Median age and adverse risk per European LeukemiaNet (ELN) were higher in the HMA + VEN cohort, while a higher proportion of patients in the CPX-351 cohort had prior myeloid malignancy and had received prior HMA therapy.
A total of 211 patients treated with CPX-351 and 226 patients treated with HMA + VEN were identified. In the overall cohort, there was no difference in complete response (CR)/CR with incomplete hematologic response (CRi) rates (57.8% vs 56.6%) and median recurrence-free survival (RFS; 33.7 vs 15.8 months; P = .132) between the 2 groups; however, median overall survival (OS) was significantly longer with CPX-351 compared with HMA + VEN (17.3 vs 11.1 months; P = .007). These results were maintained in multivariable analysis (after adjusting for age, ELN risk category, prior myeloid malignancy, and prior HMA therapy), where a significant difference favoring CPX-351 for OS was discerned (hazard ratio [HR], 0.74; P = .04).
Among patients aged 60 to 75 years (CPX-351, n = 152; HMA + VEN, n = 100), there were no differences in CR/CRi rates and median RFS in CPX-351- and HMA + VEN─treated cohorts, while there was a significant difference in OS favoring CPX-351 therapy. In multivariable subgroup analyses, a significant OS advantage favoring CPX-351 was observed in 4 subgroups, including TP53-mutated cohort, prior myeloid malignancy, prior HMA use, and ELN adverse risk. Among patients aged 60 to 75 years, a significantly higher proportion of CPX-351─treated patients underwent allogeneic stem-cell transplantation (47.7% vs 19%; P <.001); however, posttransplant, there was no difference in OS between the CPX-351- and HMA + VEN─treated cohorts.
Based on these results, and in the setting of a retrospective analysis, it was concluded that CPX-351 treatment was associated with a significant OS advantage, which, however, did not extend to CR/CRi rates and RFS.
Source: Grenet J, et al. ASH 2021; abstr 32.