2023
Safety, Pharmacodynamic, and Anti-Tumor Activity of SL-172154 As Monotherapy and in Combination with Azacitidine (AZA) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Patients (pts)
Daver N, Stein A, Bixby D, Chai-Ho W, Zeidner J, Maher K, Stevens D, Stahl M, Yee K, Curran E, Ito S, Sochacki A, Sallman D, Hernandez R, Metenou S, Ma B, Kato K, Zeidan A. Safety, Pharmacodynamic, and Anti-Tumor Activity of SL-172154 As Monotherapy and in Combination with Azacitidine (AZA) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Higher-Risk Myelodysplastic Syndromes/Neoplasms (HR-MDS) Patients (pts). Blood 2023, 142: 4278. DOI: 10.1182/blood-2023-173991.Peer-Reviewed Original ResearchR AMLAcute myeloid leukemiaTreatment-emergent AEsInfusion-related reactionsDose-limiting toxicityDose-escalation cohortsHR-MDSDose-dependent increaseComplete remissionObjective responseAnti-tumor activityBone marrowHypomethylating agentAllo-HCTAML ptsEvaluable ptsEscalation cohortsDose escalationRelapsed/Refractory Acute Myeloid LeukemiaMedian age 70 yearsMorphologic leukemia-free statePhase 1 dose escalationSIRPα-Fc fusion proteinRefractory acute myeloid leukemiaMarrow complete remissionA First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
DiNardo C, Strickland S, Skikne B, Zeidan A, Traer E, Carraway H, Frankel S, Weiss D, Wang J, Pirie-Shepherd S, Piccotti J, Wright D, Akinsanya K. A First-in-Human, Phase 1, Dose Escalation Study of Sgr-2921 As Monotherapy in Subjects with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. Blood 2023, 142: 1548. DOI: 10.1182/blood-2023-186036.Peer-Reviewed Original ResearchR AMLAcute myeloid leukemiaRefractory acute myeloid leukemiaCell line-derived xenograftsDose-escalation studyMyelodysplastic syndromeCentral nervous systemDose levelsEscalation studyFirst doseTreatment armsMyeloid leukemiaEastern Cooperative Oncology Group performance statusRelapsed/Refractory Acute Myeloid LeukemiaPatient-derived xenograft AML modelHigh-risk myelodysplastic syndromeHigh unmet medical needAnimal models representativeMultiple prior linesPhase 2 doseSingle-patient cohortsTreatment arm ATreatment arm B.Antitumor activitySingle-dose pharmacokinetics
2019
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)
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 recovery
2008
Gemtuzumab Ozogamicin (GO) and Continuous Infusion Cytarabine (ARA-C) for Relapsed/Refractory Acute Myeloid Leukemia (AML) Prior to Allogeneic Stem Cell Transplantation (SCT).
Zeidan A, Tan W, Wilding G, Ford L, Hahn T, Smiley S, Battiwalla M, McCarthy P, Wang E, Wetzler M. Gemtuzumab Ozogamicin (GO) and Continuous Infusion Cytarabine (ARA-C) for Relapsed/Refractory Acute Myeloid Leukemia (AML) Prior to Allogeneic Stem Cell Transplantation (SCT). Blood 2008, 112: 952. DOI: 10.1182/blood.v112.11.952.952.Peer-Reviewed Original ResearchDonor stem cell transplantationRefractory acute myeloid leukemiaAllogeneic stem cell transplantationStem cell transplantationAcute myeloid leukemiaUnrelated donor stem cell transplantationGemtuzumab ozogamicinBone marrow aspirationMarrow aplasiaEvaluable ptsInfectious complicationsMarrow aspirationRelapsed/Refractory Acute Myeloid LeukemiaRelated donor stem cell transplantationAcute GVHD grade IILower-intensity conditioning regimensDisease-free survival ratesContinuous infusion araContinuous infusion cytarabineGVHD grade IIIntensity conditioning regimensComplete remission durationDays post inductionAML ptsChronic GVHD