Induction and consolidation therapy with gemtuzumab ozogamicin plus FLAG (FLAG-GO) brings improved outcomes in patients with newly diagnosed core binding factor acute myeloid leukemia (CBF-AML), according to an update from a prospective phase II trial presented at the European Hematology Association 2024 Hybrid Congress.
The trial investigators, led by Gautam Borthakur, MD, of the University of Texas MD Anderson Cancer Center, are evaluating patients’ survival and monitoring for signs of optimal molecular response (OMR). They have defined OMR as the disease-defining translocation’s transcript having reduced in QPCR value to ≤0.1 by the end of induction and to ≤0.01 by the end of consolidation.
The study cohort involves 179 patients with de novo CBF AML and compares FLAG-GO induction with FLAG plus idarubicin (FLAG-IDA). 85 patients received the former regimen and 94 received the latter.
At six years, FLAG-GO showed better outcomes than FLAG-IDA in both overall survival (80% vs 70%, p=0.07) and relapse-free survival (76% vs 58%, p=0.02). There were three patient mortalities during induction.
FLAG-GO was also superior to FLAG-IDA in the percentage of patients calculated as having achieved OMR at the end of induction (61% vs 41%) and the end of consolidation (83% vs 56%).
Regarding OMR results in the trial’s 22 patients with CBF AML related to therapy, FLAG-GO again was superior to FLAG-IDA. Seven patients received FLAG-GO and 15 patients received FLAG-IDA, and a larger proportion of patients achieved OMR in the former group than in the latter group at the end of induction (71% vs 33%) and at the end of consolidation (85% vs 40%). The investigators cautioned that these small sample sizes limits their statistical analysis.
Reference
Borthakur G, Ravandi F, Kadia T, et al. FLAG regimen, combined with gemtuzumab (FLAG-GO) results in better optimal molecular response and outcomes, compared to combination with idarubicin (FLAG-IDA) in untreated core binding factor AML. Abstract P565. Presented at the EHA 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain