2024
Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2–p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets And Therapy 2024, 17: 267-280. PMID: 38567193, PMCID: PMC10986405, DOI: 10.2147/ott.s440979.Peer-Reviewed Original ResearchBiliary tract cancerAdvanced biliary tract cancerAdverse eventsDose reduction due to adverse eventsBiliary tract cancer casesChemotherapy plus immunotherapyPhase Ia/Ib trialPD-1 inhibitorsSecond-line optionAnti-tumor activityStable diseasePartial responsePD-1Treatment discontinuationCase seriesSafety profilePatientsImprove outcomesMolecular heterogeneityCancerMDM2-p53DiseaseImmunotherapyDoseEfficacy
2022
Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors.
Johnson M, Abdul-Karim R, Sommerhalder D, Hafez N, Wang S, Li C, Liu Y, Yang L, Collins S, Parot X, Strauss J. Dose escalation of a phase 1b/2 study of modakafusp alfa, an immune-targeting attenuated cytokine, in patients (pts) with metastatic solid tumors. Journal Of Clinical Oncology 2022, 40: 2503-2503. DOI: 10.1200/jco.2022.40.16_suppl.2503.Peer-Reviewed Original ResearchTreatment-related adverse eventsMetastatic solid tumorsAnti-drug antibodiesPhase 1b/2 studySolid tumorsDose escalationAttenuated cytokineGrade 4 thrombocytopeniaManageable safety profileMedian prior linesPhase 2 doseStrong clinical responseDose-escalation phaseInfusion-related reactionsDose-limiting toxicityProof of mechanismPreclinical mouse modelsImmune cell activationDose range 0.1IgG4 monoclonal antibodyQ3W dosingStable diseaseCheckpoint inhibitorsRefractory/Adverse events