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Gilteritinib and quizartinib single-agent salvage therapy in FLT3-mutated R/R AML: Real-world study by the CETLAM and PETHEMA groups
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Gilteritinib and quizartinib are second-generation FLT3 inhibitors with demonstrated efficacy and tolerability as monotherapy in two phase III clinical trials (ADMIRAL [NCT02421939] and QuANTUM-R [NCT02039726], respectively) in patients with R/R FLT3-mutated AML.1 A retrospective analysis of data from the CETLAM and PETHEMA registries was published by Vives et al.1 in Cancers, reporting real-world effectiveness and tolerability of gilteritinib and quizartinib as single-agent salvage therapy in patients with R/R FLT3-mutated AML. A total of 50 patients (gilteritinib, n = 44; quizartinib, n = 6) were included, with a median age of 62.5 years. Overall, 46% of patients had refractory disease, 54% had relapsed disease, and 56% had received ≥1 prior line of therapy.1 |
| Key learnings |
| At a median follow-up of 2.16 years, the ORR was 56%, with CR, CRi, and PR rates of 22%, 18%, and 16%, respectively. Median OS and DFS were 4.74 months and 2.99 months, respectively. |
| Patients with 1 prior line of therapy had significantly longer OS than those with ≥2 therapies (10.77 months vs 4.24 months; p = 0.016). Multivariate analysis revealed that age, WBC count, not achieving CR/CRi with gilteritinib/quizartinib, and ≥1 prior line of therapy were independent prognostic factors for OS. |
| Drug-related toxicities were observed in 70% of patients, with the most common toxicities being febrile neutropenia, liver function abnormalities, and QT interval prolongation. There were no treatment discontinuations due to drug-related SAEs. |
| Findings from this real-world study align with those observed in phase III clinical trials, supporting the effectiveness and tolerability of gilteritinib and quizartinib monotherapy as salvage treatments for patients with R/R FLT3-mutated AML, including those with previously treated with a FTL3 inhibitor. |
Abbreviations: AML, acute myeloid leukemia; CETLAM; Spanish Cooperative Group for the Diagnosis and Treatment of Acute Myeloid Leukemia and Myelodysplastic Syndromes; CR, complete remission; CRi, complete remission without hematologic recovery; DFS, disease-free survival; FLT3, FMS-like tyrosine kinase 3; ORR, overall response rate; OS, overall survival; PETHEMA; Spanish Hematology Treatment Program, PR, partial response; R/R, relapsed/refractory; SAE, serious adverse event; WBC, white blood cell.
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