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Induction and consolidation with FLAG-Ida + venetoclax in ND and R/R AML: Long-term findings from a phase II trial
While intensive chemotherapy is the mainstay for ND AML, relapse rates remain high. In addition, most patients with R/R AML have a poor prognosis. DiNardo et al. recently published findings in Leukemia from an ongoing phase II trial (NCT03214562) evaluating FLAG-IDA plus venetoclax as induction and consolidation regimens in patients with ND (n = 77; median age, 45 years) and R/R (n = 61; median age, 47 years) AML. The primary endpoint was ORR, with a median follow-up of 32 months.
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| Key learnings |
| In the ND cohort, ORR was 97% and CRc was 95% (90% MRD−). 3-year OS and EFS rates were 66% and 64%, respectively. Response rates and survival outcomes were similar across ELN 2022 risk groups. 64% of patients underwent allo-SCT in CR1. |
| In the R/R cohort, ORR was 67%, CRc was 64% (74% MRD−), 3-year OS was 32%, and 57% underwent consolidative allo-SCT in remission. Those in S1 with WT-TP53 had better outcomes, with ORR 79%, CRc 74% (76% MRD−), and 3-year OS 51%. |
| Most frequent non-hematologic AE was infection. Grade ≥3 infections during induction were febrile neutropenia (78%), bacteremia (36%), pneumonia (12%), and cellulitis (3%); rates were similar during consolidation, except for bacteremia (7%). Mortality at 30 and 60 days was 0% and 3%, respectively. |
| FLAG-IDA + venetoclax is effective and risk agnostic in ND AML, and supports remission induction in R/R AML, particularly in those with S1 and WT-TP53. Its potential to induce remissions increases allo-SCT rates, which is a key curative consolidative strategy in AML. |
Abbreviations: AE, adverse event; AML, acute myeloid leukemia; allo-SCT, allogeneic stem cell transplant; CR1, first complete remission; CRc, composite complete remission; EFS, event-free survival; FLAG-Ida, fludarabine, cytarabine, granulocyte colony-stimulating factor and idarubicin; MRD, measurable residual disease; ND, newly diagnosed; OS, overall survival; R/R, relapsed/refractory; S1, first salvage; WT, wild-type.
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