2021
Predictive Biomarkers of Response to the Polo-like Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Decitabine in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
Zeidan A, Ridinger M, Croucher P, Samuëlsz E, Erlander M, Ruffner K, Wang E. Predictive Biomarkers of Response to the Polo-like Kinase 1 (PLK1) Inhibitor, Onvansertib, in Combination with Decitabine in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML). Blood 2021, 138: 3431. DOI: 10.1182/blood-2021-145129.Peer-Reviewed Original ResearchClinical Trials CommitteeCurrent equity holderR AML patientsClinical responseTrials CommitteeGene expression signaturesSpeakers bureauAML patientsSingle agentMulticenter phase 2 studyPhase 1b/2 clinical trialRefractory acute myeloid leukemiaData Safety Monitoring CommitteeAdvisory CommitteeDaiichi SankyoSF mutationsCR/CRiPhase 2 studySafety Monitoring CommitteeChronic myelomonocytic leukemiaCycles of treatmentExpression signaturesComplete hematologic recoveryAcute myeloid leukemiaBone marrow samplesHealth-Related Quality of Life (HRQoL) during Treatment with Enasidenib (ENA) Plus Azacitidine (AZA) in Patients with Newly Diagnosed Mutant IDH2 (m IDH2) Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy (IC)
DiNardo C, Dohner H, Zeidan A, Schuh A, Vyas P, Stein E, Wei A, de Botton S, Chen C, Lord-Bessen J, Martin-Regueira P, Lersch F, Gong J, Guo S, Shi L, Montesinos P. Health-Related Quality of Life (HRQoL) during Treatment with Enasidenib (ENA) Plus Azacitidine (AZA) in Patients with Newly Diagnosed Mutant IDH2 (m IDH2) Acute Myeloid Leukemia (AML) Not Eligible for Intensive Chemotherapy (IC). Blood 2021, 138: 1244. DOI: 10.1182/blood-2021-147601.Peer-Reviewed Original ResearchClinical Trials CommitteeAcute myeloid leukemiaEQ-5D VASQLQ-C30 domainsCurrent equity holderBristol-Myers SquibbGHS/QoLGlobal health statusOverall response rateTrials CommitteeQLQ-C30 scoresEQ-5DIntensive chemotherapyPhysical functioningRole functioningDaiichi SankyoSpeakers bureauEvaluable ptsBristol-Myers Squibb CompanyHRQoL scoresDyspnea domainEQ-5D visual analog scale scoresJazz PharmaceuticalsMeaningful improvementsVisual analog scale scoreMinimal Toxicity Seen When Pembrolizumab Is Added to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease: Early Results from an Ongoing Phase II Trial (ECOG-ACRIN EA9171)
Zeidan A, Roopcharan K, Radich J, Bewersdorf J, Bhatt V, Sharon E, Little R, Gore S, Caldwell A, Luger S, Litzow M. Minimal Toxicity Seen When Pembrolizumab Is Added to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease: Early Results from an Ongoing Phase II Trial (ECOG-ACRIN EA9171). Blood 2021, 138: 3613. DOI: 10.1182/blood-2021-145015.Peer-Reviewed Original ResearchUndetectable minimal residual diseaseClinical Trials CommitteeTherapy-free remissionCombination of TKIG3 adverse eventsImmune-related AEAdverse eventsTrials CommitteeMinimal residual diseaseSafety cohortTKI discontinuationTKI therapyPD-L1Residual diseasePilot phase II clinical trialPD-1/PD-L1Detectable minimal residual diseaseImmune-related adverse eventsNon-hematologic adverse eventsAnti-PD-1 antibodyOngoing phase II trialBCR-ABLPhase II clinical trialAdvisory CommitteeDaiichi SankyoOral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study
Garcia-Manero G, McCloskey J, Griffiths E, Yee K, Zeidan A, Al-Kali A, Deeg H, Patel P, Sabloff M, Keating M, Dao K, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern A, O'Connell C, Roboz G, Busque L, Wells R, Amin H, Randhawa J, Leber B, Hao Y, Keer H, Azab M, Savona M. Oral Decitabine/Cedazuridine in Patients with Lower Risk Myelodysplastic Syndrome: A Longer-Term Follow-up of from the Ascertain Study. Blood 2021, 138: 66. PMCID: PMC8701611, DOI: 10.1182/blood-2021-144648.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesClinical Trials CommitteeMedian leukemia-free survivalMedian overall survivalRisk myelodysplastic syndromesBristol-Myers SquibbMyelodysplastic syndromeTransfusion independenceTrials CommitteeOral DECDNA methyltransferase inhibitorOverall survivalComplete responseAstex PharmaceuticalsSpeakers bureauCC-486Hematologic improvementDaiichi SankyoTreatment-emergent adverse eventsHigh-risk MDS patientsAllogeneic stem cell transplantSARS-CoV-2 infectionAdvisory CommitteeRandomized cross-over studyPandemic SARS-CoV-2 infectionOutcomes for Patients with Late-Stage Mutant-IDH2 (m IDH2) Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treated with Enasidenib Vs Other Lower-Intensity Therapies in the Randomized, Phase 3 IDHentify Trial
DiNardo C, Montesinos P, Schuh A, Papayannidis C, Vyas P, Wei A, Zeidan A, Bluemmert I, Yu X, Hasan M, Martin-Regueira P, de Botton S. Outcomes for Patients with Late-Stage Mutant-IDH2 (m IDH2) Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Treated with Enasidenib Vs Other Lower-Intensity Therapies in the Randomized, Phase 3 IDHentify Trial. Blood 2021, 138: 1243. DOI: 10.1182/blood-2021-147593.Peer-Reviewed Original ResearchClinical Trials CommitteeBest supportive careEvent-free survivalBristol-Myers SquibbIntermediate-dose cytarabineMedian overall survivalR AMLOverall survivalHematologic improvementTransfusion independenceTrials CommitteeCurrent equity holderSpeakers bureauDaiichi SankyoRefractory acute myeloid leukemiaAdvisory CommitteeAdverse-risk AMLConventional care regimensLow-dose cytarabineMedian age overallPrimary refractory AMLStudy drug doseOpen-label trialLow-intensity therapyOverall response rateVenetoclax Plus Azacitidine (VEN-AZA) Vs. Intensive Chemotherapy (IC) As Induction for Patients with Acute Myeloid Leukemia (AML): Retrospective Analysis of an Electronic Medical Records (EMR) Database in the United States
Zeidan A, Pollyea D, Borate U, Vasconcelos A, Potluri R, Rotter D, Kiendrebeogo Z, Gaugler L, Bonifacio G, Chen C. Venetoclax Plus Azacitidine (VEN-AZA) Vs. Intensive Chemotherapy (IC) As Induction for Patients with Acute Myeloid Leukemia (AML): Retrospective Analysis of an Electronic Medical Records (EMR) Database in the United States. Blood 2021, 138: 277. DOI: 10.1182/blood-2021-147926.Peer-Reviewed Original ResearchClinical Trials CommitteeRelapse-free survivalAcute myeloid leukemiaMedian relapse-free survivalCurrent equity holderElectronic medical record databaseBristol-Myers SquibbSubgroups of ptsIntensive chemotherapyIC cohortStart of therapyOverall survivalTrials CommitteeMedical record databaseRemission rateCR rateAge-based subgroupsYears subgroupRecord databaseIncomplete hematologic recovery (CRi) ratesReal-world clinical practicePhase 3 trial dataAdvisory CommitteeDaiichi SankyoGood remission rateCharacteristics and Clinical Outcome of Patients with Clonal Cytopenias of Undetermined Significance: A Large Retrospective Multi-Center International Study
Xie Z, Hyun M, Komrokji R, Zeidan A, Madanat Y, Zeidner J, Coombs C, Griffiths E, Lai C, Kishtagari A, Foran J, Badar T, Yi C, Desai P, Ades L, Osman A, Taylor J, Deeg H, Brunner A, Carraway H, Al Ali N, Bewersdorf J, Prebet T, Singh A, Tsai C, Chandhok N, Soong D, Patnaik M, Savona M, Al-Kali A. Characteristics and Clinical Outcome of Patients with Clonal Cytopenias of Undetermined Significance: A Large Retrospective Multi-Center International Study. Blood 2021, 138: 2158. DOI: 10.1182/blood-2021-146254.Peer-Reviewed Original ResearchClinical Trials CommitteeProgression-free survivalIndependent review committeeOverall survivalTrials CommitteeDisease progressionBristol-Myers SquibbMyeloid neoplasmsResponse rateFunctional pathway analysisSpeakers bureauUndetermined significanceMultivariable modelClonal cytopeniaReview CommitteeMedian progression-free survivalBoehringer IngelheimAdvisory CommitteeMulti-centre international studyCG abnormalitiesCox proportional hazards modelGene panelDaiichi SankyoBaseline clinical dataKaplan-Meier method
2020
Gilteritinib Remains Clinically Active in Relapsed/Refractory FLT3 Mutated AML Previously Treated with FLT3 inhibitors
Numan Y, Rahman Z, Grenet J, Boisclair S, Bewersdorf J, Barth D, Zeidan A, Yilmaz M, Dinner S, Deutsch Y, Frankfurt O, Litzow M, Al-Kali A, Foran J, Sproat L, Jovanovic B, Daver N, Perl A, Altman J. Gilteritinib Remains Clinically Active in Relapsed/Refractory FLT3 Mutated AML Previously Treated with FLT3 inhibitors. Blood 2020, 136: 5-7. DOI: 10.1182/blood-2020-137251.Peer-Reviewed Original ResearchStem cell transplantMedian survivalFLT3 mutationsBristol-Myers SquibbDaiichi SankyoBoehringer IngelheimCRC ratesLymphoma SocietyCombination therapyPolymerase chain reactionFLT3-ITDSingle agentDrug resistanceAdvisory CommitteeBone marrow flow cytometryComposite complete remissionFLT3-D835 mutationsHigher CRCS ratesNon-transplanted patientsPoor median survivalKaplan-Meier curvesMulti-institutional analysisLog-rank testBayer HealthCare PharmaceuticalsMAPK pathwayClinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
Savona M, McCloskey J, Griffiths E, Yee K, Al-Kali A, Zeidan A, Deeg H, Patel P, Sabloff M, Keating M, Dao K, Zhu N, Gabrail N, Fazal S, Maly J, Odenike O, Kantarjian H, DeZern A, O'Connell C, Roboz G, Busque L, Wells R, Amin H, Randhawa J, Leber B, Hao Y, Keer H, Azab M, Garcia-Manero G. Clinical Efficacy and Safety of Oral Decitabine/Cedazuridine in 133 Patients with Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML). Blood 2020, 136: 37-38. PMCID: PMC8330281, DOI: 10.1182/blood-2020-133855.Peer-Reviewed Original ResearchChronic myelomonocytic leukemiaRed blood cellsMyelodysplastic syndromeComplete responseHematological improvementAdverse eventsAstex PharmaceuticalsHypomethylating agentConsecutive weeksSpeakers bureauMedian durationClinical efficacyDaiichi SankyoDNA methyltransferase inhibitorCommon treatment-emergent adverse eventsAllogeneic hematopoietic cell transplantTreatment-emergent adverse eventsTreatment of MDSBoehringer IngelheimAdvisory CommitteeRandomized cross-over studySeattle GeneticsDose combination drugsOral hypomethylating agentOverall objective responseThe STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML)
Zeidan A, Esteve J, Giagounidis A, Kim H, Miyazaki Y, Platzbecker U, Schuh A, Sekeres M, Westermann J, Xiao Z, Malek K, Scott J, Niolat J, Peyrard S, Ma F, Kiertsman F, Stegert M, Hertle S, Fenaux P, Santini V. The STIMULUS Program: Clinical Trials Evaluating Sabatolimab (MBG453) Combination Therapy in Patients (Pts) with Higher-Risk Myelodysplastic Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML). Blood 2020, 136: 45-46. DOI: 10.1182/blood-2020-134718.Peer-Reviewed Original ResearchHigh-risk myelodysplastic syndromeHematopoietic stem cell transplantationAcute myeloid leukemiaEvent-free survivalLeukemic stem cellsIntensive chemotherapyOverall survivalPrimary endpointSecondary endpointsCurrent equity holderEligible ptsTim-3Transfusion independenceCombination therapyEastern Cooperative Oncology Group performance statusCR/CRi rateEncouraging overall response rateAdvisory CommitteeDaiichi SankyoDuration of CRTransfusion-free intervalLeukemia-free survivalComplete remission rateHigh-risk MDSProgression-free survivalMolecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine
Daigle S, Choe S, DiNardo C, Stein A, Stein E, Fathi A, Frankfurt O, Schuh A, Döhner H, Martinelli G, Patel P, Raffoux E, Tan P, Zeidan A, De Botton S, Stone R, Frattini M, Franovic A, Xu E, Winkler T, Wu B, Vyas P. Molecular Characterization of Clinical Response and Relapse in Patients with IDH1-Mutant Newly Diagnosed Acute Myeloid Leukemia Treated with Ivosidenib and Azacitidine. Blood 2020, 136: 49-51. DOI: 10.1182/blood-2020-136922.Peer-Reviewed Original ResearchPeripheral blood mononuclear cellsAcute myeloid leukemiaBone marrow mononuclear cellsCurrent equity holderIntensive induction chemotherapyAgios PharmaceuticalsSafety monitoring boardIsocitrate dehydrogenase 1Daiichi SankyoSeattle GeneticsSpeakers bureauBristol-Myers SquibbIDH2 mutationsPTC TherapeuticsClinical responseMononuclear cellsClinical trialsDisease progressionMyeloid leukemiaMonitoring boardRefractory (R/R) AMLMutant IDH1R AMLAdvisory CommitteeForty-sevenEfficacy and Safety of Luspatercept Treatment in Patients with Myelodysplastic Syndrome/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A Retrospective Analysis from the Medalist Study
Komrokji R, Platzbecker U, Fenaux P, Garcia-Manero G, Mufti G, Santini V, Diez-Campelo M, Finelli C, Jurcic J, Greenberg P, Sekeres M, Zeidan A, DeZern A, Savona M, Shetty J, Ito R, Zhang G, Ha X, Sinsimer D, Backstrom J, Verma A. Efficacy and Safety of Luspatercept Treatment in Patients with Myelodysplastic Syndrome/Myeloproliferative Neoplasm with Ring Sideroblasts and Thrombocytosis (MDS/MPN-RS-T): A Retrospective Analysis from the Medalist Study. Blood 2020, 136: 13-15. DOI: 10.1182/blood-2020-137232.Peer-Reviewed Original ResearchMDS/MPN-RSCurrent equity holderMedian leukocyte countMedian platelet countPlacebo armRing sideroblastsSpeakers bureauRBC-TIPrimary endpointClinical benefitPlatelet countTreatment optionsLeukocyte countRetrospective analysisMyelodysplastic syndrome/myeloproliferative neoplasmClass erythroid maturation agentMean serum ferritin levelWk 1Boehringer IngelheimAdvisory CommitteeDaiichi SankyoClinical benefit responseMean Hb increaseRBC transfusion independenceRegular RBC transfusionsSafety and Efficacy of Maintenance Treatment Following Allogeneic Hematopoietic Cell Transplant in Acute Myeloid Leukemia and Myelodysplastic Syndrome - a Systematic Review and Meta-Analysis
Bewersdorf J, Tallman M, Cho C, Zeidan A, Stahl M. Safety and Efficacy of Maintenance Treatment Following Allogeneic Hematopoietic Cell Transplant in Acute Myeloid Leukemia and Myelodysplastic Syndrome - a Systematic Review and Meta-Analysis. Blood 2020, 136: 34-35. DOI: 10.1182/blood-2020-136671.Peer-Reviewed Original ResearchAcute myeloid leukemiaRelapse-free survivalAllogeneic hematopoietic cell transplantHematopoietic cell transplantFLT3 inhibitorsMyelodysplastic syndromeAllo-HCTOverall survivalRFS ratesChronic GVHDMaintenance therapyCell transplantPatient selectionClinical trialsMyeloid leukemiaADC therapeuticsSystematic reviewMinimal residual disease testingAdvisory CommitteeDaiichi SankyoHigh-risk geneticsRate of GVHDPre-emptive treatmentCareful patient selectionPrognosis of patients
2019
Pharmacodynamic Responses to CC-90009, a Novel Cereblon E3 Ligase Modulator, in a Phase I Dose-Escalation Study in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML)
Fan J, Wang H, Couto S, Yao T, Uy G, Zeidan A, Minden M, Montesinos P, DeAngelo D, Altman J, Koprivnikar J, Vyas P, Fløisand Y, Vidriales M, Gjertsen B, Buchholz T, Pourdehnad M, Pierce D. Pharmacodynamic Responses to CC-90009, a Novel Cereblon E3 Ligase Modulator, in a Phase I Dose-Escalation Study in Relapsed or Refractory Acute Myeloid Leukemia (R/R AML). Blood 2019, 134: 2547. DOI: 10.1182/blood-2019-124291.Peer-Reviewed Original ResearchNovel cereblon E3 ligase modulatorCereblon E3 ligase modulatorPeripheral blood mononuclear cellsCC-90009T cellsPharmacodynamic responseCelgene CorporationDaiichi SankyoSpeakers bureauR AMLAML blastsIntegrated stress responseBlast cellsDay 1Dose levelsPhase I dose-escalation studyRefractory acute myeloid leukemiaI dose-escalation studyAdvisory CommitteeBone marrow core biopsiesAntileukemic activitySeattle GeneticsPhase IHigh-dose cohortNorwegian Cancer SocietySafety, Efficacy and Biomarker Analysis of a Phase 1b/2 Study of Onvansertib (ONV), a Polo-like Kinase 1 (PLK1) Inhibitor, in Combination with Low-Dose Cytarabine (LDAC) or Decitabine (DEC) in Patients (pts) with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Zeidan A, Schiller G, Lin T, Becker P, Patel P, Wang E, Spira A, Tsai M, Ridinger M, Croucher P, Erlander M, Silberman S. Safety, Efficacy and Biomarker Analysis of a Phase 1b/2 Study of Onvansertib (ONV), a Polo-like Kinase 1 (PLK1) Inhibitor, in Combination with Low-Dose Cytarabine (LDAC) or Decitabine (DEC) in Patients (pts) with Relapsed/Refractory Acute Myeloid Leukemia (R/R AML). Blood 2019, 134: 230. DOI: 10.1182/blood-2019-126262.Peer-Reviewed Original ResearchPositive ptsBiomarker positivityPhase 1bBristol-Myers SquibbSpeakers bureauObjective responseCount recoveryPreliminary efficacyBlood samplesNegative groupRelapsed/Refractory Acute Myeloid LeukemiaADC therapeuticsDay 1Jazz PharmaceuticalsRefractory acute myeloid leukemiaBoehringer IngelheimDaiichi SankyoIncomplete count recoveryPhase 1b/2 studyPreclinical AML modelsSubset of ptsLow-dose cytarabinePredictive gene expression signaturesDose-escalation trialPlatelet count recoveryThe Impact of the 2011 European Leukemianet (ELN) Guidelines for Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms on Therapeutic Phlebotomy and Hydroxyurea Use in Patients with Polycythemia Vera and Essential Thrombocythemia
Podoltsev N, Wang R, Shallis R, Huntington S, Zeidan A, Gore S, Davidoff A, Ma X. The Impact of the 2011 European Leukemianet (ELN) Guidelines for Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms on Therapeutic Phlebotomy and Hydroxyurea Use in Patients with Polycythemia Vera and Essential Thrombocythemia. Blood 2019, 134: 2125. DOI: 10.1182/blood-2019-127563.Peer-Reviewed Original ResearchTherapeutic phlebotomyPopulation-based cohortPV patientsELN guidelinesET patientsPolycythemia veraEssential thrombocythemiaGuideline publicationCelgene CorporationCytoreductive therapyHU useMonthly proportionBoehringer IngelheimLarge population-based cohortAdvisory CommitteeDaiichi SankyoOlder adultsEuropean LeukemiaNet guidelinesEnd Results-MedicareProportion of patientsHealthcare Common Procedure Coding System codesPopulation-based studyPatterns of careTreatment of patientsPart D claimsClinical Effectiveness of Hypomethylating Agents (HMAs) and Lenalidomide (Len) in Older Patients (pts) with Refractory Anemia with Ring Sideroblasts: A Large Population-Based Study in the United States (US)
Wang X, Wang R, Zhang C, Zeidan A, Podoltsev N, Huntington S, Gore S, Davidoff A, Ma X. Clinical Effectiveness of Hypomethylating Agents (HMAs) and Lenalidomide (Len) in Older Patients (pts) with Refractory Anemia with Ring Sideroblasts: A Large Population-Based Study in the United States (US). Blood 2019, 134: 4748. DOI: 10.1182/blood-2019-128821.Peer-Reviewed Original ResearchPopulation-based studyLR-MDSMedian overall survivalOverall survivalClinical effectivenessHypomethylating agentCelgene CorporationMedian durationRed blood cellsMedian timeRing sideroblastsBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoOlder adultsAbnormal erythroid precursorsTransfusion independence rateEnd Results-MedicareHigh-risk MDSErythropoiesis-stimulating agentsKaplan-Meier statisticsComparative clinical effectivenessEnd of studyPart D coverageIncidence and Risk Factors of Second Malignancies Among Medicare Beneficiaries with Newly-Diagnosed Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms Receiving Cytoreductive Therapy with Hydroxyurea
Wang R, Shallis R, Huntington S, Zeidan A, Gore S, Davidoff A, Ma X, Podoltsev N. Incidence and Risk Factors of Second Malignancies Among Medicare Beneficiaries with Newly-Diagnosed Philadelphia Chromosome-Negative Classical Myeloproliferative Neoplasms Receiving Cytoreductive Therapy with Hydroxyurea. Blood 2019, 134: 330. DOI: 10.1182/blood-2019-127568.Peer-Reviewed Original ResearchMyeloid hematological malignanciesHU usersPopulation-based studyHematological malignanciesCumulative incidenceCelgene CorporationMPN diagnosisCytoreductive therapySolid malignanciesGray's testPolycythemia veraMPN patientsEssential thrombocythemiaContinuous Part D coverageBoehringer IngelheimAdvisory CommitteeLarge population-based studyDaiichi SankyoImpact of hydroxyureaRetrospective cohort studyElixhauser comorbidity scorePV/ET myelofibrosisRisk regression modelsSAS version 9.4Part D coverageClinical Benefit of Glasdegib in Combination with Azacitidine or Low-Dose Cytarabine in Patients with Acute Myeloid Leukemia
Zeidan A, Schuster M, Krauter J, Maertens J, Gyan E, Joris M, Menne T, Vyas P, Wendy W, O'Connell A, Zeremski M, Kudla A, Chan G, Sekeres M. Clinical Benefit of Glasdegib in Combination with Azacitidine or Low-Dose Cytarabine in Patients with Acute Myeloid Leukemia. Blood 2019, 134: 3916. DOI: 10.1182/blood-2019-124034.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAcute myeloid leukemiaLow-dose cytarabineMedian treatment durationIntensive chemotherapyOverall survivalPersonal feesMyelodysplastic syndromeDose delaysSpeakers bureauMedian followMyeloid leukemiaTreatment durationSerious treatment-emergent adverse eventsRandomized phase 3 trialMonths median overall survivalNon-financial supportAdvisory CommitteeSeattle GeneticsDaiichi SankyoIncomplete hematologic recoveryOlder unfit patientsMedian overall survivalSuperior overall survivalAbsolute neutrophil countA Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results
Zeidan A, DeAngelo D, Palmer J, Seet C, Tallman M, Wei X, Li Y, Hock N, Burgess M, Hege K, Stock W. A Phase I Study of CC-90002, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory (R/R) Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS): Final Results. Blood 2019, 134: 1320. DOI: 10.1182/blood-2019-125363.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsR AMLHigh-risk myelodysplastic syndromeAnti-drug antibodiesAcute myeloid leukemiaMyelodysplastic syndromeADC therapeuticsJazz PharmaceuticalsDaiichi SankyoCelgene CorporationFebrile neutropeniaDose levelsDevelopment of ADAGrade treatment-emergent adverse eventsSerious treatment-emergent adverse eventsGeneral physical health deteriorationPhase I multicenter studyPrior stem cell transplantRefractory acute myeloid leukemiaRed blood cell transfusionBCR-ABL kinase domainAdvisory CommitteeAnti-CD47 monoclonal antibodyExcess blasts-2Grade 4 sepsis