High-risk AML: Paving the way to long term remission

Expert-led 3-part roundtable discussion with Prof. Charles Craddock, Prof. Maria Teresa Voso, Dr Donal McLornan and Prof. Thomas Cluzeau.

This promotional feature is sponsored by Jazz Pharmaceuticals who have had an influence on the content. INT-VYX-2000159 | November 2020

Vyxeos® Liposomal (44 mg/100 mg powder for concentrate for solution for infusion daunorubicin/cytarabine) is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
Click here for the prescribing information and details on reporting adverse events | Refer to the SmPC for full safety information

Acute Myeloid Leukemia (AML) is a complex disease, characterized by multiple somatically-acquired driver mutations.1 Therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC) are high-risk subtypes of AML. 2,3 For diagnosing patients with high-risk disease, there are a number of cytogenetic abnormalities that can be screened for in order to help further guide clinical decisions and understand more about the patients’ disease.1 In the first part of our roundtable discussion, the panel of experts discuss how they define high-risk AML, and how cytogenetic testing fits into their practice.

Unfortunately, for many patients with high-risk disease, cure or long-term survival remains elusive.4 Older patients are more likely to have high-risk AML,4,5 and have a lower likelihood of long-term remission. 6,7 Current treatment strategies with a curative intent start with intensive chemotherapy induction, followed by allogeneic hematopoietic stem cell transplantation (alloHSCT).6 Getting patients to a complete response (CR) is the first step to a potential cure in AML,4 with the highest CR rates being obtained with intensive chemotherapy.8 Therefore, intensive chemotherapy and alloHSCT still offers the highest long-term survival rates.9 Optimization of chemotherapy regimens is therefore vital to improve patient outcomes.2,10,11 Hear more below from the panel discussing which patients they take to transplantation.

One advance in the treatment of these patients is the development of the chemotherapy formulation, CPX-351 (Vyxeos® Liposomal) – a liposomal formulation of daunorubicin and cytarabine which has demonstrated superior overall survival vs conventional chemotherapy (7+3) in high-risk AML (median OS: 9.56 months (6.60-11.86) vs 5.95 months (4.99-7.75) [HR: 0.69, 95% CI: 0.52-0.90, p=0.005 (2-sided)].3,10,12

In the final part of this roundtable discussion, the recent data presented from clinical and real-world studies of CPX-351 to improve outcomes for patients are discussed.13,14 For full information on the safety and tolerability profile, please refer to the Summary of Product Characteristics.


1. Dohner H, et al. Diagnosis and management of AML in adults: 2017 ELN recommendations from an international expert panel. Blood 2017;129:424–447.

2. Granfeldt Østgård LS et al. Epidemiology and clinical significance of secondary and therapy-related Acute Myeloid Leukemia: a national population-based cohort study. J Clin Oncol 2015;33:3641–9.

3. Lancet JE et al. CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia. J Clin Oncol 2018;36:2684–729.

4. Liesveld J. Management of AML: who do we really cure? Leuk Res 2012;36:1475–80.

5. Bowcock SJ et al. High incidence of therapy-related myelodysplasia and acute leukaemia in general haematology clinic patients treated with fludarabine and cyclophosphamide for indolent lymphoproliferative disorders. Br J Haematol 2006;134:242–3.

6. Medinger M et al. Novel therapeutic options in Acute Myeloid Leukemia. Leuk Res Rep 2016;6:39–49.

7. Visser O et al. Incidence, survival and prevalence of myeloid malignancies in Europe. Eur J Cancer 2012;48:3257–66.

8. Hecker J et al. Bridging strategies to allogeneic transplant for older AML patients. Cancers 2018;10:232.

9. Bewersdorf JP et al. Are we witnessing the start of a therapeutic revolution in acute myeloid leukemia? Leuk Lymphoma 2019;60:1354–69.

10. Talati C, Lancet JE. CPX-351: changing the landscape of treatment for patients with secondary acute myeloid leukemia. Future Oncol 2018;14:1147–54.

11. Tzogani K et al. EMA review of daunorubicin and cytarabine encapsulated in liposomes (vyxeos, cpx‐351) for the treatment of adults with newly diagnosed, therapy‐related Acute Myeloid Leukemia or Acute Myeloid Leukemia with myelodysplasia‐related changes. Oncologist 2020;
doi: 10.1634/theoncologist.2019–0785.

12. Vyxeos Liposomal. European Summary of Product Characteristics October 2019.

13. Lancet JE et al. Five-year final results of a phase 3 study of CPX-351 versus 7+3 in older adults with newly diagnosed high-risk/secondary acute myeloid leukemia (EP556). Presented at 25th Congress of European Hematology Association (EHA) Virtual Meeting, 11–14 June, 2020.

14. Chiche E et al. CPX-351 Induces Deep Response and Suppress the Impact of Poor Prognosis Mutations (TP53, ASXL1, RUNX1 and EVI1) Defined By ELN-2017 in t-AML and MRC AML: A Report from a Multicentric French Cohort. Blood 2019; 134 (Supplement_1): 1355. doi: https://doi.org/10.1182/blood-2019-125623.

Click here for the prescribing information for Vyxeos® Liposomal

Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse events via their national reporting system. Adverse events should also be reported to Jazz Pharmaceuticals by email to [email protected] or by fax to +44 (0) 1865 598765

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