☆ 4.7 Review

Gilteritinib: The Story of a Proceeding Success into Hard-to-Treat FLT3-Mutated AML Patients

JOURNAL OF CLINICAL MEDICINE (2023)

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Gilteritinib activity in refractory or relapsed FLT3-mutated acute myeloid leukemia patients previously treated by intensive chemotherapy and midostaurin: a study from the French AML Intergroup ALFA/FILO

Pierre-Yves Dumas et al.

Summary: The real-world efficacy and safety of gilteritinib were assessed in a study of 167 R/R FLT3-mutated AML patients. The results showed that gilteritinib had a similar response rate and overall survival compared to the ADMIRAL trial, providing new insights into patients previously treated by intensive chemotherapy and midostaurin and beyond the 2nd line of treatment who can benefit from treatment in an outpatient setting.

LEUKEMIA (2023)

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Article Oncology

Sitravatinib as a potent FLT3 inhibitor can overcome gilteritinib resistance in acute myeloid leukemia

Yvyin Zhang et al.

Summary: The study found that Sitravatinib exhibits antitumor activity against FLT3-ITD mutation in AML cells by inhibiting proliferation, inducing cell cycle arrest, and promoting apoptosis. In vivo experiments showed that Sitravatinib had a better therapeutic effect compared to Gilteritinib. Additionally, Sitravatinib demonstrated the ability to overcome resistance to FLT3 inhibitors. Therefore, the study reveals the potential therapeutic role of Sitravatinib in FLT3 mutant AML.

BIOMARKER RESEARCH (2023)

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Letter Hematology

Favorable pharmacokinetic and pharmacodynamic properties of gilteritinib in cerebrospinal fluid: a potential effective treatment in relapsing meningeal acute myeloid leukemia FLT3-ITD patients

Nicolas Vignal et al.

HAEMATOLOGICA (2023)

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Overcoming relapse: prophylactic or pre-emptive use of azacitidine or FLT3 inhibitors after allogeneic transplantation for AML or MDS

Yuho Najima

Summary: Relapse remains a significant challenge in allogeneic hematopoietic stem cell transplantation (HSCT), with high relapse mortality. Post-transplant maintenance treatment with hypomethylating agents and FLT3 inhibitors has been investigated for preventing disease relapse after HSCT. Factors such as disease status at HSCT and conditioning regimen intensity can impact the transition of disease burden in HSCT patients. Optimal selection of high-risk relapse patients who can tolerate long-duration therapy is crucial for successful post-transplant maintenance therapy. This review provides an overview of current progress and future outlook in post-transplant maintenance treatment for preventing disease relapse after HSCT for AML or MDS, using azacitidine or FLT3 inhibitors.

INTERNATIONAL JOURNAL OF HEMATOLOGY (2023)

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Article Hematology

Outcomes in Patients with FLT3-Mutated Relapsed/Refractory Acute Myelogenous Leukemia Who Underwent Transplantation in the Phase 3 ADMIRAL Trial of Gilteritinib versus Salvage Chemotherapy

Alexander E. Perl et al.

Summary: The ADMIRAL trial investigated the efficacy of using the FLT3 inhibitor gilteritinib as maintenance therapy after hematopoietic stem cell transplantation (HSCT) in patients with relapsed or refractory FLT3-mutated AML. The results showed that gilteritinib maintenance therapy improved survival rates and was well-tolerated in patients post-HSCT.

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Article Hematology

Gilteritinib clinical activity in relapsed/refractory FLT3 mutated acute myeloid leukemia previously treated with FLT3 inhibitors

Yazan Numan et al.

Summary: This research analyzed 113 patients with relapsed/refractory FLT3(mut+) AML who received gilteritinib treatment and found a CRc rate of 48.7%. Among patients who received 7+3 and midostaurin treatment, the CRc rate after gilteritinib treatment was 58% with a median survival of 7.8 months. Patients who achieved CR, especially those with a cMRD negative response, had the longest survival.

AMERICAN JOURNAL OF HEMATOLOGY (2022)

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Article Hematology

Follow-up of patients with R/R FLT3-mutation-positive AML treated with gilteritinib in the phase 3 ADMIRAL trial

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Summary: The follow-up of the ADMIRAL trial after 2 years demonstrates that gilteritinib is a safe and effective treatment option for patients with relapsed/refractory FLT3-mutation-positive AML. Gilteritinib therapy provides superior overall survival and long-term remission compared to salvage chemotherapy, especially when used as post-HSCT maintenance.

BLOOD (2022)

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Molecular profile of FLT3-mutated relapsed/refractory AML patients in the phase 3 ADMIRAL study of gilteritinib

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Timothy T. Ferng et al.

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Article Oncology

Clinical outcomes in patients with relapsed/refractory FLT3-mutated acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib

Alexander E. Perl et al.

Summary: Gilteritinib is effective for FLT3-mutated relapsed/refractory AML, even in patients who had prior treatment with sorafenib or midostaurin. However, remission durations are shorter in patients with prior FLT3 TKI exposure.

BLOOD CANCER JOURNAL (2022)

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Article Hematology

Gilteritinib monotherapy for relapsed/refractory FLT3 mutated acute myeloid leukemia: a real-world, multi-center, matched analysis

Shai Shimony et al.

Summary: The study found that gilteritinib is effective for patients with FLT3-mutated relapsed or refractory AML, including those who have undergone intensive treatment and TKI exposure.

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Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN

Hartmut Doehner et al.

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Venetoclax Plus Gilteritinib for FLT3-Mutated Relapsed/Refractory Acute Myeloid Leukemia

Naval Daver et al.

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AML-256 A Phase 1 Study of Gilteritinib in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia: Final Study Results

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Gilteritinib Maintenance Therapy Post-Allogenic Stem-Cell Transplantation Improves the Prognosis of Patients with FLT3-Mutated AML

Toshiki Terao et al.

BLOOD (2022)

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Efficacy and Safety of Gilteritinib Vs. Sorafenib As Post-Transplant Maintenance in Patients with FLT3-ITD Acute Myeloid Leukemia

Jason Yeh et al.

BLOOD (2022)

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Midostaurin after allogeneic stem cell transplant in patients with FLT3-internal tandem duplication-positive acute myeloid leukemia

Richard T. Maziarz et al.

Summary: The study evaluated the efficacy of adding midostaurin to standard-of-care treatment in preventing relapse following alloHSCT in FLT3-ITD AML patients. Results showed an 18-month RFS rate of 89% in the midostaurin maintenance therapy group compared to 76% in the SOC group. The inhibition of FLT3 phosphorylation to <70% of baseline was associated with improved RFS, indicating potential clinical benefit in some patients.

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Article Hematology

Gilteritinib for Relapsed Acute Myeloid Leukaemia with FLT3 Mutation during the COVID-19 Pandemic: Real World Experience from the UK National Health Service

Jad Othman et al.

BLOOD (2021)

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Article Hematology

2021 Update on MRD in acute myeloid leukemia: a consensus document from the European LeukemiaNet MRD Working Party

Michael Heuser et al.

Summary: The European LeukemiaNet MRD Working Party updated the 2018 MRD recommendations, including technical specifications and integrative assessments. They also proposed the use of MRD as a prognostic and surrogate endpoint for drug testing, as well as the clinical implications of MRD assessment in AML. Recommendations include technical requirements for flow cytometry and molecular MRD analysis, as well as reporting methods for MRD results.

BLOOD (2021)

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Article Oncology

A new pre-emptive TKIs strategy for preventing relapse based on BCR/ABL monitoring for Ph plus ALL undergoing allo-HCT: a prospective clinical cohort study

Hui Liu et al.

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LEUKEMIA (2021)

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Review Hematology

Differentiation syndrome with lower-intensity treatments for acute myeloid leukemia

Amir T. Fathi et al.

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AMERICAN JOURNAL OF HEMATOLOGY (2021)

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Single-cell DNA sequencing reveals complex mechanisms of resistance to quizartinib

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A Relapsing Meningeal Acute Myeloid Leukaemia FLT3-ITD+ Responding to Gilteritinib

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CHEMOTHERAPY (2021)

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Phase 1 first-in-human study of irreversible FLT3 inhibitor FF-10101-01 in relapsed or refractory acute myeloid leukemia.

Mark J. Levis et al.

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Summary: In patients receiving gilteritinib therapy, concomitant use of antifungal triazoles did not increase the risk of gilteritinib-related adverse events, with similar rates of side effects and treatment outcomes in both groups.

LEUKEMIA RESEARCH (2021)

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Review Hematology

Hypomethylating Agents and FLT3 Inhibitors As Maintenance Treatment for Acute Myeloid Leukemia and Myelodysplastic Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation-A Systematic Review and Meta-Analysis

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Patterns of Resistance Differ in Patients with Acute Myeloid Leukemia Treated with Type I versus Type II FLT3 Inhibitors

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BLOOD CANCER DISCOVERY (2021)

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BLOOD (2020)

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Ryan S. Kim et al.

JAMA OPHTHALMOLOGY (2020)

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Sorafenib Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia With FLT3-Internal Tandem Duplication Mutation (SORMAIN)

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Clonal Selection with RAS Pathway Activation Mediates Secondary Clinical Resistance to Selective FLT3 Inhibition in Acute Myeloid Leukemia

Christine M. McMahon et al.

CANCER DISCOVERY (2019)

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Emerging Mutations at Relapse in Patients with FLT3-Mutated Relapsed/Refractory Acute Myeloid Leukemia Who Received Gilteritinib Therapy in the Phase 3 Admiral Trial

Catherine C. Smith et al.

BLOOD (2019)

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Nicholas J. Short et al.

THERAPEUTIC ADVANCES IN HEMATOLOGY (2019)

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Christine M. McMahon et al.

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Oncotarget (2018)

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