ASH 2024 | AML-MR mutations drive the benefit of CPX-351 over 7+3 in the pivotal Phase III AML trial
Shai Shimony, MD, Dana-Farber Cancer Institute, Boston, MA, comments on the benefits of CPX-351 over traditional 7+3 chemotherapy in patients with high-risk acute myeloid leukemia (AML) treated in the pivotal Phase III trial (NCT01696084). He highlights the benefits for those with myelodysplasia-related mutations (AML-MR) but notes that patients with TP53-mutated AML did not have a survival benefit when treated with CPX-351 versus 7+3. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript
In the pivotal Phase III trial, CPX-351 or Vyxeos is a liposomal formulation of daunorubicin and cytarabine improved survival compared with the traditional 7 plus 3 in patients with high-risk AML between the age of 60 to 75. The inclusion criteria of the trial were clinically defined or cytogenetically defined secondary AML or therapy-related AML. However, these inclusion criteria are no longer relevant in the current diagnostic landscape, which is now defined based on genetically or biologically groups...
In the pivotal Phase III trial, CPX-351 or Vyxeos is a liposomal formulation of daunorubicin and cytarabine improved survival compared with the traditional 7 plus 3 in patients with high-risk AML between the age of 60 to 75. The inclusion criteria of the trial were clinically defined or cytogenetically defined secondary AML or therapy-related AML. However, these inclusion criteria are no longer relevant in the current diagnostic landscape, which is now defined based on genetically or biologically groups. Thus, we re-analyzed all the data from the pivotal Phase III trial based on reclassification of genetic subsets. Our results showed that patients with what we call AML-MR mutations or myelodysplasia-related mutations defined by the new WHO 2022 criteria benefit from Vyxeos in terms of survival when compared with 7 plus 3. This benefit was mainly driven by patients who proceeded with transplant. Conversely, patients with TP53 AML did not benefit from Vyxeos compared with 7 plus 3 in terms of survival and with the notion that myelosuppression was more prominent across all genetic groups, this calls into question the use of CPX-351 in patients with TP53 mutated AML.
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