This site is intended for United Kingdom/Ireland healthcare professionals
Improved OS vs DA Therapy2
30% reduction in
relative risk of death
with Vyxeos Liposomal
vs. DA therapy2
Absolute risk reduction=10%
Hazard ratio (HR) 0.70 (95% confidence interval [CI] 0.55, 0.91)
Events (n/N): 124/153 with Vyxeos Liposomal vs 145/156 with 3+7
Median OS 9.33 (95% CI 6.37, 11.86) with Vyxeos Liposomal vs 5.95 (95% CI 4.99, 7.75) for 3+7
What are you trying to achieve with your patient?
View outcome-based results in patients who achieved remission:
Improved Overall Remission Rates vs DA Therapy1
CR/CRi was achieved by 73 (48%) patients in the Vyxeos Liposomal arm and 52 (33%) patients in the DA therapy arm1
View 5-year OS data for patients who achieved CR/CRi:
Early Mortality Rates vs DA Therapy1,4
60-day mortality due to persistent or progressive disease was lower for Vyxeos Liposomal vs DA therapy
(3.3% vs 11.3%, respectively)4
(not statistically significant)
Vyxeos Liposomal Efficacy at a Glance
Study 3011,5 | England6 (N=211) | France7 (N=103) | Italy8 (N=71) | Germany9 (N=188) | ||
---|---|---|---|---|---|---|
Vyxeos Liposomal (N=153) | DA 3+7 (N=156) | |||||
Median OS, months | 9.6 | 6.0 | 12.9 | 16.1 | NR (68.6% at 12 months) | 21 |
(p=0.009) | ||||||
Median OS post-HSCT, months | NR | 10.25 | NR (72% at 12 months) | NR | NR (100% at 12 months) | NR (73% at 12 months) |
(p=0.009) | ||||||
CR, n/N (%) | 37% | 26% | NA | 57/103 (55) | 38/71 (54) | NA |
(p=0.04) | ||||||
CR+CRi, n/N (%)* | 48% | 33% | NA | 61/103 (59) | 46/71 (65) | 85/179 (47) |
(p=0.016) | ||||||
CR+CRi+PR, n/N (%)* | NA | NA | NA | 52/71 (73) | NA | |
MRD negativity, n/N (%)* | NA | NA | 16/28 (57) | ~50%† | 23/36 (64) |
* Following induction
† Flow cytometry-based MRD assessment data were available from 17/31 centres (54.8%) for 40/71 patients (56.3%) and the MRD negativity rate was 37.5% (15/40 patients). WT1-based MRD was available for 15/31 (48.4%) centres for 38/71 patients (53.5%) and the MRD negativity rate was 53.8% (21/38 patients)
View the efficacy outcomes of Vyxeos Liposomal in real-world cohorts
Study 301: A Robust Trial Design1,10
Study Overview
Study 301 was a Phase 3, randomised, open-label, active-controlled study of Vyxeos Liposomal vs conventional chemotherapy (DA 3+7)1,10
Eligible patients were 60–75 years old with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), including prior MDS or CMML, and de novo AML with MDS1,10
309 patients took part in the study: 153 were randomised to Vyxeos Liposomal and 156 patients were randomised to the conventional chemotherapy arm1,10
There were similar patient characteristics across both treatment arms1,10
The Primary endpoint of the study was OS, measured from the date of randomisation until death due to any cause.1,2 The key secondary endpoints were remission rates, event-free survival, safety, early mortality and remission duration1
Study 301 Trial Design1
Patient and Disease Characteristics
AML Subtypes