Does real-world evidence still support intensive chemotherapy for high-risk AML*?

Expert-led 4-part roundtable discussion with Professors Martin Bornhäuser, Roberto Lemoli and Thomas Cluzeau.

This promotional feature is sponsored by Jazz Pharmaceuticals who have had an influence on the content. INT-VYX-2100064| June 2021

Vyxeos® Liposomal (44 mg/100 mg powder for concentrate for solution for infusion daunorubicin/cytarabine) (CPX-351) 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 for Vyxeos® Liposomal | Refer to the SmPC for full safety information

*High-risk AML is defined as t-AML and AML-MRC

For many patients with Acute Myeloid Leukemia (AML), long-term survival or even cure remains elusive.1 Patients with high-risk disease, including therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC), have particularly poor outcomes.2,3 For patients on a curative treatment pathway, intensive chemotherapy induction followed by allogeneic hematopoietic stem cell transplantation (alloHSCT) still provides the highest long-term survival rates in patients with AML.4

Historically, 7+3 regimens (cytarabine infusion for 7 days with 3 once-daily injections of anthracycline) have been the standard of care for induction therapy.3 CPX-351 – a liposomal formulation of daunorubicin and cytarabine5 – changed the landscape beyond standard chemotherapy induction6, and has demonstrated superior overall survival (OS) vs 7+3 in high-risk AML (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]). Additionally, after a follow up of 5 years from the pivotal Phase III study, improved OS was maintained (9.33 months [6.37–11.86] vs 5.95 months [4.99–7.75]: HR=0.70, 95% CI: 0.55–0.91).7

Following on from the Phase III study, two real-world studies have been conducted in Italy8 and France9 to review the efficacy and safety of CPX-351 outside of a trial setting. In the first part of our roundtable discussion, the panel review data from the study in Italy and the outcomes demonstrated.

Part 1) Real-world evidence in high-risk AML: Italy

‘A recent long-term follow-up study with a follow-up of five years has shown real efficacy and advantage [of CPX-351] compared to 3+7’
Martin Bornhäuser

‘Not only in view of stem cell transplantation, CPX-351 might be an optimal therapy for high-risk disease, but as reported at the EHA meeting 2020, also patients non-eligible for allogeneic stem cell transplantation, might enjoy long-term remission and long-term survival’
Roberto Lemoli

Continuing with real-world evidence in high-risk AML, the panel discuss the experience in France and the outcomes demonstrated.

Part 2) Real-world evidence in high-risk AML: France


‘Our data of course, confirms the results of the phase III clinical trial already published with safety [and] overall survival in this high-risk population’

Thomas Cluzeau

Choosing the right treatment for each individual patient depends on a number of factors – their health status and treatment goals initially, balanced alongside physician experience and judgement. Hear more below from the panel discussing the practical issues around selecting patients for chemotherapy induction followed by alloHSCT.

Part 3) Choosing the right patient for chemotherapy induction


‘I think that high-dose chemotherapy still represents the backbone of the treatment for [high-risk] AML’

Roberto Lemoli

In the final part of their discussion, the panel highlight why chemotherapy is still an important treatment option for patients with high-risk AML.

Part 4) Why chemotherapy is still important in high-risk AML


‘I think we all agreed on the fact that as soon as we…decide on that a patient with high-risk AML is eligible for a curative therapeutic approach, we think the majority of the evidence still points to an intensive chemotherapy approach’

Martin Bornhäuser

References

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

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

5. Vyxeos Liposomal. European Summary of Product Characteristics January 2021.

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

7. 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

8. Guolo F et al. CPX-351 treatment in secondary acute myeloblastic leukemia is effective and improves the feasibility of allogeneic stem cell transplantation: results of the Italian compassionate use program. Blood Cancer J 2020;10:96.

9. Chiche E et al. Real-life experience with CPX-351 and impact on the outcome of high-risk AML patients: a multicentric French cohort. Blood Adv 2021;5:176–184.

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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