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A new analysis by researchers demonstrates that combination therapy consisting of fludarabine, cytarabine and G-CSF (FLAG) plus gemtuzumab ozogamicin (GO) or idarubicin (IDA) continues to deliver strong long-term outcomes for patients with core-binding factor acute myeloid leukaemia (CBF-AML), a subtype of the disease involving a chromosomal rearrangement.
The study, published in Blood Cancer Discovery, was co-led by Gautam Borthakur, M.D., professor of Leukaemia, and Jayastu Senapati, M.D., assistant professor of Leukaemia.
The researchers analysed long-term outcomes from a cohort of patients treated in a Phase 2 trial. The five-year overall survival rate reached 74%, while the relapse-free survival rate was 67% for patients treated in this study.
Among patients who had received GO along with FLAG (FLAG-GO), the five-year overall survival rate was superior at 80% as opposed to FLAG-IDA on non-randomised comparisons.
“This is one of the highest reported five-year, relapse-free overall survival rates we have observed,” Borthakur said.
“This regimen is now our standard frontline therapy for adults with core-binding factor AML, and these findings further strengthen the evidence supporting its use.”
Why are these findings significant?
CBF‑AML is considered a favourable‑risk leukaemia, but relapse remains a major challenge. The ability to demonstrate high, five-year overall survival rates with FLAG-based therapy, particularly FLAG-GO, confirms this regimen is safe and provides durable efficacy, according to the researchers.
The Phase 2 clinical trial treated 219 newly diagnosed patients at UT MD Anderson. Researchers also examined whether baseline concurrent myeloid mutations influenced treatment outcomes.
The study showed that these mutations — including KIT mutations, which traditionally have been considered adverse — did not impact survival outcomes and the dynamics of deep molecular responses achieved by the patients.
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