Clinical Lymphoma, Myeloma & Leukemia, Vol.23, Suppl.1 - September 2023

Abstracts Clinical Lymphoma, Myeloma & Leukemia September 2023 S272 remission, and 37.5% achieved complete remission, resulting in an overall response rate of 54.1%. The median overall survival was 44 months, and disease-free survival was 22 months. The 5-year survival rate was 33%. Conclusion: The administration of a low dose of GO as salvage therapy for r/r AML showed improved overall survival and disease-free survival rates. The safety profile of GO treatment was generally favorable, with manageable toxicities. Keywords: acute myeloid leukemia, gemtuzumab, case report AML-132 QuANTUM‑First Trial: FLT3–Internal Tandem Duplication (FLT3‑ITD)– Specific Measurable Residual Disease (MRD) Clearance Is Associated With Improved Overall Survival (OS) Mark J. Levis MD1, Harry P. Erba MD2, Pau Montesinos MD3, Radovan Vrhovac MD4, Elżbieta Patkowska MD5, Hee-Je Kim MD6, Pavel Zak MD7, Po-Nan Wang MD8, Jaime E. Connolly Rohrbach PhD9, Ken C.N. Chang PhD9, James Hanyok PharmD9, Li Liu PhD9, Yasser Mostafa Kamel MD9, Arnaud Lesegretain MBA9, Jorge Cortes MD10, Mikkael A. Sekeres MD11, Hervé Dombret MD12, Sergio Amadori MD13, Jianxiang Wang MD14, Richard F. Schlenk MD15, Alexander E. Perl MD16 1Johns Hopkins University, Baltimore, USA. 2Duke Cancer Institute, Durham, USA. 3La Fe University and Polytechnic Hospital, Valencia, Spain. 4University Hospital Centre Zagreb, Zagreb, Croatia. 5Institute of Hematology and Blood Transfusion, Warsaw, Poland. 6Catholic Hematology Hospital, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea, Republic of. 7University Hospital Hradec Kralove, Hradec Kralove, Czech Republic. 8Chang Gung Medical Foundation, Linkou, Taiwan. 9Daiichi Sankyo, Inc., Basking Ridge, USA. 10Augusta University Medical Center, Augusta, USA. 11Sylvester Cancer Center, University of Miami Health System, Miami, USA. 12Saint Louis Hospital, University of Paris, Paris, France. 13Tor Vergata Polyclinic Hospital Rome, Rome, Italy. 14Institute of Hematology and Blood Diseases Hospital, Tianjin, China. 15Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany. 16University of Pennsylvania, Philadelphia, USA Context: Detection of MRD has an established prognostic role in acute myeloid leukemia (AML) and is used to guide treatment decisions. Objective: To determine whether detection of MRD using FLT3-ITD in QuANTUM-First (NCT02668653) impacted clinical outcomes or the benefits provided by the FLT3 inhibitor quizartinib in patients with newly diagnosed FLT3-ITD+ AML. Design: DNA was isolated from the bone marrow or peripheral blood of patients who achieved remission after induction and analyzed with FLT3ITD polymerase chain reaction next-generation sequencing. ITD mutations detected after induction were cross-validated against those detected at enrollment. Using a custom bioinformatics program, ITD mutations were identified and variant mutant allelic frequencies (VAFs) calculated with a sensitivity of 10-5. MRD was classified as undetectable (using the 0 cutoff) or detectable above or below the 10-4 cutoff. Comparisons of complete response (CR), composite complete response (CRc=CR+CR with incomplete count recovery [CRi]), and percentages of patients achieving CR during induction with no MRD between treatment arms were made using a stratified Cochran-Mantel-Haenszel test. Comparison of the FLT3ITD+ VAF during induction between treatment arms was made using the Wilcoxon rank sum test. P values were not adjusted for multiplicity. Results: Of the 539 randomized patients, 368 (68.3%) achieved CRc after induction; MRD analysis was performed on 321 of these (87.2%) using samples collected at the time of response assessment during induction. A best response of CRc with MRD <10-4 correlated with improved OS (HR=0.562). The percentage of patients in CRc with FLT3-ITD MRD <10-4 was similar across study arms (quizartinib, 25.4%; placebo, 21.8%; P=0.3430), whereas the percentage of patients in CRc with undetectable MRD was greater with quizartinib vs placebo (12.3% vs 7.0%; P=0.0403). The median FLT3-ITD+ VAF was 3-fold lower (P=0.0251) in patients on quizartinib. Additional data about MRD impact with and without allogeneic hematopoietic stem cell transplantation will be presented. Conclusions: This first evidence of the prognostic effect of FLT3-ITD–specific MRD in a prospective trial demonstrates the potential utility of this assay in the management of patients with FLT3-ITD+ AML. Long-term OS benefits conferred by quizartinib in QuANTUM-First may, in part, derive from an early and deep reduction of the FLT3-ITD+ leukemia burden. Keywords: acute myeloid leukemia, FLT3-ITD, measurable residual disease, NGS, PCR, quizartinib, phase III AML-137 Real‑Life Experience of Mexican Patients Treated With FLAG‑VIDA Regimen in Relapsed/Refractory Acute Myeloid Leukemia (AML) and Next Generation Sequencing (NGS) Analysis of the Cases Carlos Cruz BSc1, Nidia Zapata MSc2, Judith Cruz MSc2, Diana Arcos MSc2 1Instituto Nacional de cancerologia, Mexico, Mexico. 2Instituto Nacional de Cancerologia, Mexico, Mexico Context: AML is a malignant disease of hematopoietic stem and progenitor cells with a median age of onset of approximately 67 years and an annual incidence of 3 to 8 per 100,000. Even though two-thirds of AML patients respond to induction chemotherapy and achieve complete response (CR), the majority of them will eventually relapse. Approximately 10% to 40% of younger AML patients are primarily refractory to AML induction therapy. Across European Leukemia Net (ELN) risk groups, FLAG-IDA and venetoclax (FLAG-VIDA) result in high CR rates. Diploid and intermediate-risk cytogenetics predicted favorable outcomes. Objective: The aim of this study is to present the molecular and cytogenetic characteristics of Mexican patients with AML in relapsed and refractory disease (R/R), and the outcomes with FLAG-VIDA treatment in our institute between 2021 and 2023. Thirteen cases were reviewed and identified for analysis. Results: All patients

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