Dr Erba on the Role of Quizartinib in Newly Diagnosed FLT3-ITD+ AML

Harry Erba, MD, PhD, a professor of medicine, an investigator in the Division of Hematologic Malignancies and Cellular Therapy in the Department of Medicine, director of the Leukemia Program and director of Phase I Development in Hematologic Malignancies at Duke Cancer Institute, discusses the role of quizartinib (Vanflyta) for the treatment of newly diagnosed patients with FLT3-ITD–positive acute myeloid leukemia (AML).

In July 2023, the FDA approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed AML that is FLT3-ITD positive, as detected by an FDA-approved test. The regulatory decision was supported by data from the phase 3 QuANTUM-First trial (NCT02668653), where findings showed that patients treated with the quizartinib-based regimen achieved a statistically significant and clinically meaningful improvement in overall survival (OS) compared with those given chemotherapy plus placebo (HR, 0.78; 95% CI, 0.62-0.98; 2-sided P = .0324).

Following the FDA approval of quizartinib, it is important to conduct PCR testing to identify patients with newly diagnosed AML who may be candidates for this regimen, Erba explains, adding that FLT3-ITD mutations are found in approximately 25% to 30% of this patient population. Erba also notes that these patients typically have a high white blood cell count at diagnosis.

For patients with FLT3-ITD–positive AML, the availability of the quizartinib regimen represents an advance in treatment options, Erba says. Notably, findings from a post-hoc analysis of QuANTUM-First showed that patients under 60 years of age who were treated with the quizartinib regimen experienced a 32% reduction in the risk of death compared with chemotherapy alone (HR, 0.68; 95% CI, 0.49-0.95), whereas the OS benefit was not statistically significant for patients 60 years of age or older (HR, 0.91; 95% CI, 0.66-1.26). More research is needed in the older patient population to better identify those who would benefit from intensive chemotherapy, Erba concludes.