Vyxeos Liposomal Delivers
Quadruple Endpoint Superiority vs DA 3+7¹

mOS

9.56 vs 5.95 months,
HR 0.69 (95% CI 0.52, 0.90); p=0.003

post-
HSCT
mOS

NR vs 10.25 months;
HR 0.46 (95% CI 0.24, 0.89); p=0.009

CR/CRi

48% vs 33%;
p=0.016

EFS

2.53 vs 1.31 months;
HR 0.74 (95% CI, 0.58, 0.96); p=0.021

Improved OS vs DA Therapy²

Study 301 primary endpoint: OS in older adults with newly-diagnosed high-risk* AML²

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:

OS from the date of HSCT²

OS in patients who did not receive HSCT³

Improved Overall Remission Rates vs DA Therapy¹

Study 301 secondary endpoint: complete response (CR)/CR with incomplete haematological recovery (CRi) rates in older adults with newly-diagnosed high-risk AML (primary analysis)¹

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:

OS in patients who achieved CR/CRi²

Early Mortality Rates vs DA Therapy^1,4

Study 301 secondary endpoint: Early mortality rates in older adults with newly-diagnosed high-risk AML^1,4

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 301^1,5		England⁶ (N=211)	France⁷ (N=103)	Italy⁸ (N=71)	Germany⁹ (N=188)
	Vyxeos Liposomal (N=153)	DA 3+7 (N=156)	England⁶ (N=211)	France⁷ (N=103)	Italy⁸ (N=71)	Germany⁹ (N=188)
Median OS, months	9.6	6.0	12.9	16.1	NR (68.6% at 12 months)	21
Median OS, months	(p=0.009)		12.9	16.1	NR (68.6% at 12 months)	21
Median OS post-HSCT, months	NR	10.25	NR (72% at 12 months)	NR	NR (100% at 12 months)	NR (73% at 12 months)
Median OS post-HSCT, months	(p=0.009)		NR (72% at 12 months)	NR	NR (100% at 12 months)	NR (73% at 12 months)
CR, n/N (%)	37%	26%	NA	57/103 (55)	38/71 (54)	NA
CR, n/N (%)	(p=0.04)		NA	57/103 (55)	38/71 (54)	NA
CR+CRi, n/N (%)*	48%	33%	NA	61/103 (59)	46/71 (65)	85/179 (47)
CR+CRi, n/N (%)*	(p=0.016)		NA	61/103 (59)	46/71 (65)	85/179 (47)
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

View

Study 301: A Robust Trial Design^1,10

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 MDS^1,10

309 patients took part in the study: 153 were randomised to Vyxeos Liposomal and 156 patients were randomised to the conventional chemotherapy arm^1,10

There were similar patient characteristics across both treatment arms^1,10

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

https://vyxeos.co.uk/wp-content/uploads/2022/06/study_design_UK_GRAPH_Study_Design_Overview-01-01.svg

Study 301 Trial Design¹

https://vyxeos.co.uk/wp-content/uploads/2022/06/patient_characteristics_UK_GRAPH_Disease_Characteristics-01-1-01.svg

Patient and Disease Characteristics

AML Subtypes

RELATED CONTENT

Comparable safety profile with prolonged myelosuppression vs DA therapy^2,10

Discover more

Watch UK AML experts discuss the RWE of Vyxeos Liposomal from BSH ’22 on our interactive learning webpage

Watch now

FOOTNOTES

*High-risk AML is defined as therapy-related AML or AML with myelodysplasia-related changes

ABBREVIATIONS

AML, acute myeloid leukaemia; AML-MRC, acute myeloid leukaemia with myelodysplasia-related changes; CI, confidence interval; CMML, chronic myelomonocytic leukaemia; CR/CRi, complete remission/complete remission with incomplete haematological recovery; DA, daunorubicin and cytarabine; ECOG, Eastern Cooperative Oncology Group; EFS, event-free survival; HR, hazard ratio; HSCT, haematopoietic stem cell transplantation; MDS, myelodysplastic syndrome; mOS, median overall survival; MRD, minimal residual disease; NA, not applicable; NR, not reached; OR, odds ratio; OS, overall survival; PR, partial response; PS, performance score; RWE, real-world evidence; sAML, secondary acute myeloid leukaemia; t-AML, treatment-related acute myeloid leukaemia; WT1, Wilms’ tumour 1

REFERENCES

Lancet JE, et al. J Clin Oncol 2018;36(26):2684–2692
Lancet JE, et al. E-poster EP556. EHA25 Virtual Congress 2020
Lin TL, et al. E-poster EP562. EHA25 Virtual Congress 2020
Lancet JE, et al. J Clin Oncol 2016;34(15):suppl 7000
Lancet JE, et al. Lancet Haematol 2021;8(7):e481–e491
Legg A, et al. Abstract P513. EHA Annual Congress 2022
Chiche E, et al. Blood Adv 2021;5(1):176–184
Guolo F, et al. Blood Cancer J 2020;10(10):96
Rautenberg C, et al. Blood Cancer J 2021;11:164
Vyxeos Liposomal Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/9442/smpc