Dr Coombs on the Ongoing Investigation of Quizartinib in AML

Catherine C. Coombs, MD, associate clinical professor, University of California, Irvine (UCI), UCI School of Medicine, discusses the efficacy and ongoing investigation of the FLT3 inhibitor quizartinib (Vanflyta) in acute myeloid leukemia (AML).

In July 2023, quizartinib plus standard chemotherapy was approved by the FDA for the treatment of adult patients with newly diagnosed, FLT3-ITD–positive AML based on findings from the pivotal phase 3 QuANTUM-First trial (NCT02668653), Coombs begins. This trial enrolled patients up to 75 years old, and patients were stratified according to whether they were younger or older than 60 years of age, she states.

Data from QuANTUM-First were published in The Lancet in 2023, and showed that treatment with the quizartinib regimen significantly prolonged overall survival (OS) compared with placebo, Coombs reports. At a median follow-up of 39.2 months (IQR, 31.9-45.8), the median overall survival was 31.9 months (95% CI, 2.0-not estimable) in the quizartinib arm vs 15.1 months (95% CI, 13.2-26.2) in the placebo arm (HR, 0.78; 95% CI, 0.62-0.98; 2-sided P = .032).

Notably, the trial revealed that younger patients experienced a more significant benefit with the addition of quizartinib to standard chemotherapy compared with older patients, where the survival curves between quizartinib and placebo largely overlapped, Coombs adds.

Coombs continues by stating that AML remains a complicated disease to treat, and the integration of molecular data is essential for personalized therapeutic strategies in this space. Real-world studies have demonstrated that incorporating molecular testing into clinical practice is feasible, providing valuable information to guide treatment decisions, she notes.

Overall, the QuANTUM-First trial underscores the value of targeted therapies like quizartinib in patients with specific genetic alterations, Coombs emphasizes. Quizartinib represents an effective treatment option for patients with FLT3-ITD-positive AML, offering an additional tool in the treatment arsenal against this challenging disease, she concludes.