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EHA 2024: Topline findings of the TUD-APOLLO-064 trial and their potential clinical implications
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During the European Hematology Association (EHA) 2024 Hybrid Congress, the AML Hub was pleased to speak with Uwe Platzbecker, University of Leipzig Medical Center, Leipzig, DE. We asked, What were the topline findings of the TUD-APOLLO-064 trial and their potential clinical implications?
EHA 2024: Topline findings of the TUD-APOLLO-064 trial and their potential clinical implications
Professor Platzbecker shares the study design and latest data from the TUD-APOLLO-064 trial of arsenic trioxide combined with all-trans retinoic acid (ATRA-ATO) and idarubicin vs standard ATRA and anthracycline-based chemotherapy (ATRA-CHT) for the treatment of newly diagnosed, high-risk acute promyelocytic leukemia (APL). Platzbecker discusses the promising event-free survival data favoring the novel combination, without an increase in toxicities or mortality compared with the comparator arm. Platzbecker closes by providing his insight on how these data may influence the future treatment paradigm for patients with high-risk APL.
Key data and learnings from Professor Platzbecker’s presentation at EHA 2024 include1:
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The primary endpoint, of two-year event free survival (EFS), was met with an EFS rate of 88% in the ATRA-ATO cohort and 70% for ATRA-CHT (p = 0.02).
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Five-year overall survival was higher in the ATRA-ATO cohort at 93% versus 82% in the ATRA-CHT cohort (p = 0.17).
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Two-year incidence of relapse was significantly higher in patients treated with ATRA-CHT at 14% compared with 1.6% for ATRA-ATO (p = 0.011).
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The incidence of complete remission (CR) or CR with incomplete recovery was not significantly different between the two cohorts (it was numerically higher in the ATRA-ATO cohort at 93% versus 90% with ATRA-CHT (p = 0.654)).
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There was no increased risk of early mortality with the novel ATRA-ATO regimen.
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Data presented support the implementation of the ATRA-ATO regimen as a first-line therapy in high-risk APL.
- Platzbecker U. First results of the APOLLO trial: a randomized phase III study to compare ATO combined with ATRA versus standard AIDA regimen for patients with newly diagnosed, high-risk acute promyelocytic leukemia. Oral abstract #S102. Presented at: European Hematology Association 2024 Hybrid Congress; Jun 13–16, 2024; Madrid, ES.
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