INTENSIVE CHEMOTHERAPY

COULD YOUR ACUTE MYELOID LEUKAEMIA WITH MYELODYSPLASIA-RELATED CHANGES (AML-MRC) AND THERAPY-RELATED AML (T-AML) PATIENTS BENEFIT FROM INTENSIVE CHEMOTHERAPY (IC)?

There is an unmet need in AML-MRC and t-AML1-3

These patients tend to have complex karyotypes, lower remission rates, and shorter OS with conventional IC compared to those with de novo AML1,4,5

Monotherapy with low-dose cytarabine or azacitidine in these patients is associated with poor outcomes compared with IC +/- HSCT*1

View data

Yet, patients with AML-MRC and t-AML have historically been less likely to receive intensive treatment than those with de novo AML1

* In a retrospective study of 9,758 patients with AML, IC was compared with low-dose cytarabine or azacitidine with or without HSCT
† High-risk AML is defined as t-AML and AML-MRC

Play
Erin Hurst – Defining high-risk AML†

In AML-MRC and t-AML, consider using Vyxeos Liposomal first

AML working group and American Society of Hematology (ASH) guidelines support IC in AML-MRC and t-AML6,7

For patients who are fit enough:

  • The use of IC over less intensive therapy is suggested by the ASH guidelines for treating newly diagnosed AML in older adults6
See the ASH 2020 recommendations6
  • The use of Vyxeos Liposomal in patients with adverse risk cytogenetics is supported by the AML working group guidelines on treating AML during the coronavirus disease (COVID) pandemic7
See the AML working group recommendations7

Vyxeos Liposomal is licensed for the treatment of adults with newly diagnosed AML-MRC and t-AML and reimbursed throughout the UK and Ireland10–13

Gain insight into the NCRI guidelines with co-author Richard Dillon
and leading AML experts Erin Hurst and Amit Patel

Play

Erin Hurst - The NCRI guidelines on high-risk AML patients: A summary

Richard Dillon - Treating high-risk AML patients during the COVID-19 crisis: the NCRI guidelines explained

Amit Patel - The impact of COVID-19 pressures on treatment selection

Discuss the guidelines in more detail with your Jazz representative
Get in touch here

Vyxeos Liposomal can benefit patients who:

  • Are transplant-ineligible
  • Are transplant-eligible
  • Prefer a simple, finite treatment course

With Vyxeos Liposomal, patients had a
~2x longer median OS vs. daunorubicin + cytarabine (DA) 3+714

Study 301 post-hoc analysis:

OS in older adults with newly diagnosed AML-MRC or t-AML, who achieved CR or CR with incomplete platelet or neutrophil recovery (CRi) but did not undergo HSCT14

Over 14 months median OS with Vyxeos Liposomal vs 7.59 months with DA 3+714

HR 0.57 (95% CI 0.31, 1.03)

Events (n/N): 21/33 with Vyxeos Liposomal vs 22/28 with DA 3+7

Median OS: 14.72 (95% CI 9.33, 25.43) with Vyxeos Liposomal vs 7.59 (95% CI 4.86, 10.87) with DA 3+7

Considerations for treating transplant-ineligible patients

Play

Erin Hurst – Using Vyxeos Liposomal in transplant ineligible patients

Amit Patel – Treatment selection: The importance of long-term data in counselling patients

Amit Patel – Treatment selection: The role of patient wishes

Find out more about the role of Vyxeos Liposomal in the AML landscape

Contact your Jazz representative

Median OS was not reached with Vyxeos Liposomal
vs 10.25 months with DA 3+715

Study 301 post-hoc analysis:

OS in older adults with newly diagnosed AML-MRC or t-AML, who achieved CR or CRi but did not undergo HSCT15

35% (53/153) patients received HSCT with Vyxeos Liposomal vs 25% (39/156) with DA 3+715

Play
Erin Hurst – Using Vyxeos Liposomal in transplant eligible patients

During the COVID pandemic, the AML working group recommends:

Patients with a high likelihood of disease progression without transplantation should still be considered candidates for allograft according to normal clinical practice7

See the AML working group guidance on HSCT in the context of the COVID pandemic

Vyxeos Liposomal has a simplified infusion schedule vs DA 3+10 and can be administered in an ambulatory setting at consolidation10,16–18

Fewer administration days with Vyxeos Liposomal vs DA 3+710,16,17

Vyxeos Liposomal has a 90-minute infusion time10

In addition, Vyxeos Liposomal has a fixed schedule and duration of treatment whereas azacitidine therapy is ongoing until disease progression10,19

During the COVID-19 pandemic, the AML working group recommends:

Patients with a high likelihood of disease progression without transplantation should still be considered candidates for allograft according to normal clinical practice7

The AML working group COVID-19 guidelines recommend HSCT in t-AML and s-AML7

Outpatient delivery in Study 301

51% of Vyxeos Liposomal patients received their first consolidation as outpatients vs 6% for DA 3+718

Despite prolonged myelosuppression, patients treated with Vyxeos Liposomal experienced a better survival rate vs DA 3+720

  • Neutropenia
  • Thrombocytopenia
Median time (days) to neutrophil recovery after first induction* was:

35

Range:
29-41

Study 301‡20,21

29

Range:
19-146

French cohort§22

38

Range:
12-60

Italian cohort§23

* Time point not stated in the Italian study. † Interquartile range. ‡ Time to recovery (absolute neutrophil count ≥500/µL) after first induction. § Recovery was defined as > 500/µL

The rates of 30- and 60-day mortality were lower with Vyxeos Liposomal despite the increase in myelosuppression vs DA 3+720,24

For more information and support on managing myelosuppression with Vyxeos Liposomal
Reach out to your Jazz representative
Median time (days) to platelet recovery after first induction* was:

36.5

Range:
29-43

Study 301‡20,21

28

Range:
12-77

French cohort§22

28

Range:
12-60

Italian cohort¶23

* Time point not stated in the Italian study. † Interquartile range. ‡ Time to recovery (platelet count ≥50,000/µL) after first induction. § Recovery was defined as >20,000/µL. ¶ Recovery was defined as >25,000/µL

The rates of 30- and 60-day mortality were lower with Vyxeos Liposomal despite the increase in myelosuppression vs DA 3+720,24

Case Studies

Case Studies

Treating AML in the COVID-19 landscape

Explore case studies of patients with AML-MRC and t-AML treated during the pandemic:

Play

Dr Choudhuri - 67-year-old transplant ineligible male patient with AML-MRC and a complex karyotype

Dr Munisamy - 69-year-old female patient who contracted COVID-19 during treatment and did not proceed to transplant

Dr Mannari - 71-year-old male patient with therapy-related AML who did not proceed to tranplant

Watch as Amit Patel and Erin Hurst discuss the need to ensure AML patients continue to receive the right treatment as COVID-19 continues to have an impact on healthcare systems

Play

Erin Hurst - Lessons from the first waves of COVID-19

Amit Patel - Standard of care in treating patients with high-risk AML during the COVID-19 pandemic

In AML-MRC and t-AML, consider using Vyxeos Liposomal first.

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    Related content

    Simplified infusion schedule reduces the number of administration days vs DA 3+718

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    Superior OS vs DA 3+7 in patients with high-risk AML15,20

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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-2100205 l September 2021