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-p53DiseaseImmunotherapyDoseEfficacyA Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors
Falchook G, Patnaik A, Richardson D, Harvey R, Sharma M, Hafez N, Hamilton E, Piha-Paul S, Barve M, Wise-Draper T, Patel M, Dowlati A, Pascuzzo J, Tang S, Faltermeier C, Malinowska I, Shtessel L, Striha A, Potocka E. A Relative Bioavailability, Bioequivalence, and Food Effect Study of Niraparib Tablets in Patients with Advanced Solid Tumors. Clinical Therapeutics 2024, 46: 228-238. PMID: 38423866, DOI: 10.1016/j.clinthera.2024.01.004.Peer-Reviewed Original ResearchHigh-fat mealFood effectPK parametersSolid tumorsGeometric least square meansAdvanced ovarian cancerAdvanced solid tumorsFood effect studyEstimate PK parametersSafety populationOpen-labelStandard therapyOvarian cancerPK variabilityFE stageMaintenance treatmentNiraparibDisease progressionSafety signalsTreatment periodInhibitor niraparibConcentration dataPatientsFasting stateCapsule formulation
2021
P01.06 CX-2029, a Probody Drug Conjugate Targeting CD71 in Patients With Selected Tumor Types: PROCLAIM-CX-2029 Dose Expansion Phase
Johnson M, Ahnert J, Lakhani N, Sanborn R, El-Khoueiry A, Hafez N, Mamdani H, Boni V, Castro H, Hannah A, Spira A. P01.06 CX-2029, a Probody Drug Conjugate Targeting CD71 in Patients With Selected Tumor Types: PROCLAIM-CX-2029 Dose Expansion Phase. Journal Of Thoracic Oncology 2021, 16: s238. DOI: 10.1016/j.jtho.2021.01.330.Peer-Reviewed Original Research
2018
OA05.01 Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy
Hellmann M, Jänne P, Opyrchal M, Hafez N, Raez L, Gabrilovich D, Wang F, Ordentlich P, Brouwer S, Sankoh S, Schmidt E, Meyers M, Ramalingam S. OA05.01 Efficacy/Safety of Entinostat (ENT) and Pembrolizumab (PEMBRO) in NSCLC Patients Previously Treated with Anti-PD-(L)1 Therapy. Journal Of Thoracic Oncology 2018, 13: s330. DOI: 10.1016/j.jtho.2018.08.257.Peer-Reviewed Original ResearchA phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma.
Lakhani N, LoRusso P, Hafez N, Krishnamurthy A, O'Rourke T, Kamdar M, Fanning P, Zhao Y, Jin F, Wan H, Pons J, Randolph S, Messersmith W. A phase 1 study of ALX148, a CD47 blocker, alone and in combination with established anticancer antibodies in patients with advanced malignancy and non-Hodgkin lymphoma. Journal Of Clinical Oncology 2018, 36: 3068-3068. DOI: 10.1200/jco.2018.36.15_suppl.3068.Peer-Reviewed Original ResearchEfficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with non-small cell lung cancer (NSCLC) previously treated with anti-PD-(L)1 therapy.
Gandhi L, Janne P, Opyrchal M, Ramalingam S, Rybkin I, Hafez N, Raez L, Gabrilovich D, Wang F, Ordentlich P, Brouwer S, Sankoh S, Schmidt E, Meyers M, Hellmann M. Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with non-small cell lung cancer (NSCLC) previously treated with anti-PD-(L)1 therapy. Journal Of Clinical Oncology 2018, 36: 9036-9036. DOI: 10.1200/jco.2018.36.15_suppl.9036.Peer-Reviewed Original Research