2023
Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies
Kontro M, Stein A, Pyörälä M, Rimpiläinen J, Siitonen T, Hollmén M, Fjaellskog M, Pawlitzky I, Zeidan A, Daver N. Encouraging Efficacy Observed in Bexmab Study: A Phase 1/2 Study to Assess Safety and Efficacy of Bexmarilimab in Combination with Standard of Care in Myeloid Malignancies. Blood 2023, 142: 2915. DOI: 10.1182/blood-2023-174912.Peer-Reviewed Original ResearchAcute myeloid leukemiaR AMLCLEVER-1Complete remissionStandard of careBex treatmentAdverse eventsBone marrow cellsHMA failureMarrow CRPatient BMPrior therapyPartial remissionAML patientsMedian numberT cellsDose levelsMyeloid malignanciesHigh-risk MDS patientsMarrow cellsMarrow complete remissionR AML patientsRisk MDS patientsNK cell numbersPhase 1/2 studySpliceosome mutations are associated with clinical response in a phase 1b/2 study of the PLK1 inhibitor onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia
Croucher P, Ridinger M, Becker P, Lin T, Silberman S, Wang E, Zeidan A. Spliceosome mutations are associated with clinical response in a phase 1b/2 study of the PLK1 inhibitor onvansertib in combination with decitabine in relapsed or refractory acute myeloid leukemia. Annals Of Hematology 2023, 102: 3049-3059. PMID: 37702821, PMCID: PMC10567832, DOI: 10.1007/s00277-023-05442-9.Peer-Reviewed Original ResearchAcute myeloid leukemiaR AML patientsAML patientsMyeloid leukemiaRefractory (R/R) AMLRelapsed/refractory (R/R) AMLHigher CR/CRi ratesCR/CRi rateRefractory acute myeloid leukemiaGene signaturePhase 1b/2 studyPhase 1b/2 trialPhase 1b trialBone marrow blastsSF mutationsBone marrow samplesCRi rateComplete remissionMarrow blastsClinical responseCount recoveryInitial safetyMarrow samplesPotential therapyMolecular predictors
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 samples
2019
1066O Polo-like kinase 1 (PLK1) inhibitor, onvansertib, in combination with low-dose cytarabine or decitabine in patients with relapsed/refractory acute myeloid leukaemia in phase Ib
Zeidan A, Becker P, Patel P, Schiller G, Tsai M, Lin T, Wang E, Erlander M, Cortes J. 1066O Polo-like kinase 1 (PLK1) inhibitor, onvansertib, in combination with low-dose cytarabine or decitabine in patients with relapsed/refractory acute myeloid leukaemia in phase Ib. Annals Of Oncology 2019, 30: v435. DOI: 10.1093/annonc/mdz251.001.Peer-Reviewed Original ResearchTarget engagementEvaluable ptsHigh dosesRefractory acute myeloid leukemiaInhibition of PLK1CR/CRiLow-dose cytarabinePreclinical AML modelsR AML patientsDose-escalation phasePolo-like kinase 1Anti-leukaemic activityAcute myeloid leukemiaEvaluable patientsLDAC armBM blastsDose escalationAML patientsPolo-like kinase 1 inhibitorsEscalation phaseBiomarker statusMyeloid leukemiaSelective PLK1 inhibitorBlood samplesHigh dose