5-YEAR RESULTS OF STUDY 301 IN OLDER PATIENTS WITH HIGH-RISK* ACUTE MYELOID LEUKAEMIA (AML) NOW AVAILABLE:
SUPERIOR OVERALL SURVIVAL (OS) VS. DAUNORUBICIN CYTARABINE (DA) THERAPY1,2

5-Year Data for Vyxeos Liposomal: Perspectives From the United Kingdom (UK)

Significantly increased OS with Vyxeos Liposomal vs. DA therapy over 5 years1,2

HR 0.70 (95% CI 0.55, 0.91)

Significantly greater remission rates with Vyxeos Liposomal vs. DA therapy2

(p=0.016)

Lower early mortality rates with Vyxeos Liposomal than with DA therapy2,3

(not statistically significant)

  • Overall Survival
  • Remission Rates
  • Early Mortality

Superior OS vs. DA Therapy1

Study 301 primary endpoint: OS in older adults with newly-diagnosed high-risk* AML1

30% reduction in
relative risk of death
with Vyxeos Liposomal
vs. DA therapy1

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

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View outcome-based results in patients who achieved remission:
OS from the date of HSCT1
OS in patients who did not receive HSCT4

Significantly Greater Remission Rates vs. DA Therapy2

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)2

CR/CRi was achieved by 73 (48%) patients in the Vyxeos Liposomal arm and 52 (33%) patients in the DA therapy arm2

Odds ratio (OR): 1.77 (1.11, 2.81); p=0.016

View 5-year OS data for patients who achieved CR/CRi:

OS in patients who achieved CR/CRi1

Lower Early Mortality Rates vs. DA Therapy2,3

Study 301 secondary endpoint: Early mortality rates in older adults with newly-diagnosed high-risk AML2,3

60-day mortality due to
persistent or progressive disease
was lower for Vyxeos Liposomal
vs. DA therapy
(3.3% vs. 11.3%, respectively)3

(not statistically significant)

View the efficacy outcomes of Vyxeos Liposomal in real-world cohorts

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Study 301: A Robust Trial Design2,5

Study Overview

The Phase 3 study was a randomised, open-label, active-controlled study of Vyxeos Liposomal vs. conventional chemotherapy (3+7) in patients aged 60–75 years with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC)2,5

Patients were diagnosed with t-AML, de novo AML with myelodysplastic syndrome (MDS) karyotype, or t-AML – AML with a history of MDS and chronic myelomonocytic leukaemia (CMML) with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 22,5

309 patients took part in the study: 153 were randomised to Vyxeos Liposomal and 156 patients were randomised to the conventional chemotherapy arm2,5

There were similar patient characteristics across both treatment arms2,5

The primary endpoint of the study was OS. Efficacy was established on the basis of OS 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 duration2

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Study 301 Trial Design2

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Patient and Disease Characteristics

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AML Subtypes

Vyxeos Liposomal: An Innovative Mode of Action2,5-7

Vyxeos Liposomal is the first dual-drug advanced liposomal formulation of daunorubicin and cytarabine designed to optimise efficacy of treatment in high-risk AML2,6

Synergistic Ratio

Fixed 1:5 molar ratio of DA within an advanced liposomal formulation5

Prolonged

Synergistic molar ratio maintained for a prolonged period of time – over 24 hours after administrations5,7

High Concentration

Vyxeos Liposomal accumulates and persists in the bone marrow in high concentrations in animal models5

Preferential Uptake

Vyxeos Liposomal is preferentially taken up by leukaemia cells vs. normal bone marrow cells in leukaemia-bearing mice5

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Comparable safety profile with prolonged
myelosuppression vs. DA therapy1,5

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Simplified infusion schedule reduces
the number of administration days
vs. DA therapy8

 

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ADVERSE EVENTS REPORTING

Adverse events should be reported. Reporting forms and information for the UK can be found at https://yellowcard.mhra.gov.uk/

For Ireland, reporting forms and information can be found at: www.hpra.ie

Adverse events should also be reported to Jazz Pharmaceuticals at AEreporting@jazzpharma.com

UK-VYX-2100209 l September 2021