2024
Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia
Montesinos P, Cheong J, Daver N, Fathi A, Levis M, Luger S, Miyamoto T, Oliva E, Perl A, Récher C, Schlenk R, Wang J, Zeidan A, Liu L, Duong Y, Imadalou K, Alexis K, Nahar A, Burns K, Erba H. Trial in Progress: The Phase 3, Randomized, Double-Blind, Placebo-Controlled QuANTUM-Wild Study of Quizartinib in Combination With Chemotherapy and as Single-Agent Maintenance in Newly Diagnosed, FLT3 -ITD-Negative Acute Myeloid Leukemia. Blood 2024, 144: 1504.3-1504.3. DOI: 10.1182/blood-2024-205101.Peer-Reviewed Original ResearchFMS-like tyrosine kinase 3Acute myeloid leukemiaRelapse-free survivalEvent-free survivalArm AOverall survivalEligible ptsFLT3-ITDMonotherapy maintenanceAllo-HSCTDouble-blindFLT3 mutationsArm CMyeloid leukemiaAssociated with significantly prolonged overall survivalFLT3 activationFms-like tyrosine kinase 3 ligandFMS-like tyrosine kinase 3-internal tandem duplicationAllogeneic hematopoietic stem cell transplantationFms-like tyrosine kinase 3-mutatedRelapsed/refractory acute myeloid leukemiaBone marrow blast countFms-like tyrosine kinase 3 expressionCases of acute myeloid leukemiaHematopoietic stem cell transplantation
2022
A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes
Zeidan AM, Boss I, Beach C, Copeland WB, Thompson E, Fox BA, Hasle VE, Ogasawara K, Cavenagh J, Silverman LR, Voso MT, Hellmann A, Tormo M, O'Connor T, Previtali A, Rose S, Garcia-Manero G. A randomized phase 2 trial of azacitidine with or without durvalumab as first-line therapy for higher-risk myelodysplastic syndromes. Blood Advances 2022, 6: 2207-2218. PMID: 34972214, PMCID: PMC9006291, DOI: 10.1182/bloodadvances.2021005487.Peer-Reviewed Original ResearchConceptsHigh-risk myelodysplastic syndromeAdverse eventsArm BArm ASubcutaneous azacitidineMyelodysplastic syndromeTreatment cyclesRandomized phase 2 trialInhibitory immune checkpoint moleculesHematologic adverse eventsMedian overall survivalFirst-line therapyFirst-line treatmentPhase 2 studyPhase 2 trialImmune checkpoint moleculesOverall response rateBone marrow granulocytesAzacitidine monotherapyIntravenous durvalumabCheckpoint moleculesOverall survivalClinical outcomesMarrow granulocytesGrade 3
2019
Efficacy and Safety of Azacitidine (AZA) in Combination with the Anti-PD-L1 Durvalumab (durva) for the Front-Line Treatment of Older Patients (pts) with Acute Myeloid Leukemia (AML) Who Are Unfit for Intensive Chemotherapy (IC) and Pts with Higher-Risk Myelodysplastic Syndromes (HR-MDS): Results from a Large, International, Randomized Phase 2 Study
Zeidan A, Cavenagh J, Voso M, Taussig D, Tormo M, Boss I, Copeland W, Gray V, Previtali A, O'Connor T, Rose S, Beach C, Silverman L. Efficacy and Safety of Azacitidine (AZA) in Combination with the Anti-PD-L1 Durvalumab (durva) for the Front-Line Treatment of Older Patients (pts) with Acute Myeloid Leukemia (AML) Who Are Unfit for Intensive Chemotherapy (IC) and Pts with Higher-Risk Myelodysplastic Syndromes (HR-MDS): Results from a Large, International, Randomized Phase 2 Study. Blood 2019, 134: 829. DOI: 10.1182/blood-2019-122896.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromePD-L1 surface expressionAcute myeloid leukemiaPlatinum-containing chemotherapyPhase 2 studyIntensive chemotherapyArm AMyeloid blastsCelgene CorporationAML ptsMedian OSPD-L1AML cohortDisease progressionSurface expressionTreatment groupsTreatment cyclesECOG performance status 0First large randomized trialLarger phase 2 studiesPD-L1 blocking antibodiesRandomized phase 2 studyConcurrent platinum-based chemotherapyResponse criteriaSafety of azacitidine