Combination therapy yields strong long-term overall response rate in newly diagnosed acute myeloid leukemia patients
MD Anderson News Release March 06, 2025
Intensive chemotherapy remains the standard treatment option for medically fit patients with newly diagnosed acute myeloid leukemia (AML). However, many patients face relapse. In a Phase II trial led by Courtney DiNardo, M.D., patients with newly diagnosed and relapsed/refractory AML were treated with a novel combination of fludarabine, cytarabine, granulocyte colony-stimulating factor, and idarubicin (FLAG-IDA) combined with venetoclax. The overall response rate was 97% in newly diagnosed patients, with 95% achieving undetectable measurable residual disease status. Importantly, complete remission and three-year overall survival rates were similar across all AML risk categories, suggesting a particular benefit for select patients with high-risk disease. In relapsed/refractory patients, the highest benefit was seen when the combination was used early. Patients who had only one prior treatment and wildtype TP53 had an overall response rate of 79%, and 57% of these patients were able to transition to stem cell transplantation, the only potential curative consolidative treatment in relapsed/refractory AML. Learn more in Leukemia.
This novel combination therapy yielded impressive and strong overall response rates for patients with newly diagnosed AML. The therapy was effective at inducing remissions, not just in this cohort but also in patients with relapsed or refractory AML, making it a strong treatment option over the current standard-of-care regimen.