2024
669P CBX-12-101: Final results of a phase I study of CBX-12, a peptide drug conjugate (PDC) in patients (pts) with metastatic solid tumors
Lorusso P, Meric-Bernstam F, Hafez N, Rivera I, Tripathy D, Wilks S, Pearson P, Needle M, Tolcher A. 669P CBX-12-101: Final results of a phase I study of CBX-12, a peptide drug conjugate (PDC) in patients (pts) with metastatic solid tumors. Annals Of Oncology 2024, 35: s525. DOI: 10.1016/j.annonc.2024.08.735.Peer-Reviewed Original Research372 TABLET: food effect study of niraparib tablets in patients with advanced solid tumours
Richardson D, Falchook G, Donald Harvey R, Sharma M, Hafez N, Hamilton E, Patnaik A, Piha-Pau S, Barve M, Wise-Draper T, Patel M, Dowlati A, Pascuzzo J, Tang S, Faltermeier C, Malinowska I, Shtessel L, Striha A, Potocka E. 372 TABLET: food effect study of niraparib tablets in patients with advanced solid tumours. 2024, a257.1-a257. DOI: 10.1136/ijgc-2024-esgo.499.Peer-Reviewed Original ResearchEfficacy 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 formulationEfficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.
Macarulla T, Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2024, 42: 487-487. DOI: 10.1200/jco.2024.42.3_suppl.487.Peer-Reviewed Original ResearchBiliary tract cancerTreatment-related AEsAdvanced biliary tract cancerMonotherapy trialsStable diseasePartial responseCombination trialsMouse double minute 2MDM2-p53 antagonistsEscalating dosesSolid tumorsCases of biliary tract cancerTP53 wild-type tumorsAnti-PD-1 antibodyStandard-of-care chemotherapyData cut-offWild-type tumorsAdvanced/metastatic solid tumorsResponding ptsMDM2-p53MDM2 amplified tumorsDouble minute 2MDM2-amplifiedAmpullary adenocarcinomaCell cycle arrest
2023
Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.
Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Gounder M, Geng J, Li J, Teufel M, Maerten A, LoRusso P. Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. Journal Of Clinical Oncology 2023, 41: 543-543. DOI: 10.1200/jco.2023.41.4_suppl.543.Peer-Reviewed Original ResearchAdvanced biliary tract cancerBiliary tract cancerTreatment-related AEsMost common gradeMonotherapy trialsCombination trialsStable diseaseTract cancerExpansion trialGallbladder carcinomaCommon gradeAnti-PD-1 antibodyWhite blood cell countManageable safety profileAdvanced solid tumorsBiliary tract adenocarcinomaBlood cell countRange of malignanciesPreclinical antitumor activityNegative prognostic markerPotential antitumor strategyAmpullary adenocarcinomaIIb trialAmpullary carcinomaSafety profile
2022
Principles of Dose, Schedule, and Combination Therapy
Eder J, Hafez N. Principles of Dose, Schedule, and Combination Therapy. 2022, 1-13. DOI: 10.1002/9781119000822.hfcm055.pub3.Peer-Reviewed Original ResearchAcute myeloid leukemiaCombination chemotherapyMonoclonal antibodiesChemotherapeutic agentsHigh single-agent activityContemporary cancer therapyContinuous oral administrationSingle-agent activityBone marrow transplantationClinical toxicity profileCytotoxic chemotherapeutic agentsDose-response effectTyrosine kinase inhibitorsOutcome of therapyRapid plasma clearanceClinical trial designCombination of agentsDeoxyribonucleic acid damaging agentsNormal tissue recoveryPolymerase inhibitor rucaparibRole of doseMost chemotherapeutic agentsPrecise pathologic diagnosisTumor cell sensitivityHematopoietic growth factorsDose 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 eventsA phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.
Yamamoto N, Hafez N, Tolcher A, Teufel M, Geng J, Svensson L, Lahmar M, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2022, 40: 3095-3095. DOI: 10.1200/jco.2022.40.16_suppl.3095.Peer-Reviewed Original ResearchDose-limiting toxicityImmune checkpoint inhibitorsDoublet combinationsCheckpoint inhibitorsPrimary endpointPhase Ia/Ib studySolid tumorsManageable safety profileMDM2-p53 antagonistsProgression-free survivalAdvanced solid tumorsBiliary tract carcinomaMetastatic solid tumorsSoft tissue sarcomasAnti-tumor effectsWild-type cancersAnti-tumor activityLogistic regression modelsPhase IaMultiple tumor typesG3 anemiaG3 neutropeniaG4 thrombocytopeniaIA/IBMurine double minuteKRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation.
Bekaii-Saab T, Spira A, Yaeger R, Buchschacher G, McRee A, Sabari J, Johnson M, Barve M, Hafez N, Velastegui K, Christensen J, Kheoh T, Der-Torossian H, Rybkin I. KRYSTAL-1: Updated activity and safety of adagrasib (MRTX849) in patients (Pts) with unresectable or metastatic pancreatic cancer (PDAC) and other gastrointestinal (GI) tumors harboring a KRASG12C mutation. Journal Of Clinical Oncology 2022, 40: 519-519. DOI: 10.1200/jco.2022.40.4_suppl.519.Peer-Reviewed Original ResearchDisease control rateKRAS G12C mutationProgression-free survivalPartial responseGI tumorsClinical activityG12C mutationPancreatic cancerSolid tumorsMedian progression-free survivalTreatment-related adverse eventsGrade 3/4 eventsGrade 5 eventsPhase 1/2 studyAdvanced solid tumorsMetastatic pancreatic cancerMetastatic solid tumorsEncouraging clinical activityPhase 2 cohortExtensive tissue distributionKRAS G12C inhibitorsFavorable pharmacokinetic propertiesEvaluable ptsKRASG12C mutationData cutoff
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
2020
A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors.
Tolcher A, Hafez N, Yamamoto N, Park J, Grempler R, Lucarelli A, Lahmar M, Wang B, Gounder M. A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 and BI 754111 in patients (pts) with advanced solid tumors. Journal Of Clinical Oncology 2020, 38: tps3660-tps3660. DOI: 10.1200/jco.2020.38.15_suppl.tps3660.Peer-Reviewed Original ResearchDose-limiting toxicityProgression-free survivalPrimary endpointSecondary endpointsPhase IbPhase Ia/Ib studySolid tumorsAnti-PD-1 antibodyMeasurable target lesionsAdvanced solid tumorsMaximum-tolerated doseFirst treatment cycleMetastatic solid tumorsAnti-LAG-3 antibodyTP53 wild-type tumorsAnti-tumor effectsWild-type cancersWild-type tumorsTP53 mutation statusLogistic regression modelsMultiple tumor typesEvaluable ptsIA/IBMurine double minutePFS ratesCX-2029, a PROBODY drug conjugate targeting CD71 (transferrin receptor): Results from a first-in-human study (PROCLAIM-CX-2029) in patients (Pts) with advanced cancer.
Johnson M, El-Khoueiry A, Hafez N, Lakhani N, Mamdani H, Rodon Ahnert J, Sanborn R, Ho T, Li R, Waldes J, Spira A. CX-2029, a PROBODY drug conjugate targeting CD71 (transferrin receptor): Results from a first-in-human study (PROCLAIM-CX-2029) in patients (Pts) with advanced cancer. Journal Of Clinical Oncology 2020, 38: 3502-3502. DOI: 10.1200/jco.2020.38.15_suppl.3502.Peer-Reviewed Original ResearchTreatment-related AEsAntibody-drug conjugatesHuman studiesCommon treatment-related AEsTumor modelObserved safety profileInfusion-related reactionsPK/PD analysisAdvanced solid tumorsAnti-tumor activityXenograft tumor modelMedian molar ratiosMultiple xenograft tumor modelsTumor-associated proteasesECOG 0Dose cohortsStable diseasePartial responsePhase 1/2Systemic therapyAdvanced cancerDose escalationSafety profileGrade 3Ocular melanoma
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
2016
Docetaxel in Advanced and Castration Resistant Prostate Cancer
Petrylak D, Hafez N. Docetaxel in Advanced and Castration Resistant Prostate Cancer. 2016, 77-92. DOI: 10.1007/978-3-319-31341-2_6.Peer-Reviewed Original ResearchResistant prostate cancerProstate cancerMetastatic castrate-resistant prostate cancerCastrate-resistant metastatic diseaseMetastatic castrate-resistant diseaseCastration-resistant prostate cancerCastrate-resistant prostate cancerResistant metastatic diseaseCastrate-resistant diseasePrimary chemotherapeutic agentStandard of careDocetaxel useTaxane cabazitaxelMetastatic diseaseDocetaxel efficacyRandomized trialsResistant diseaseLocal diseaseSuperior survivalDocetaxelChemotherapeutic agentsCancerDiseaseCorticosteroidsCabazitaxelThe impact of androgen deprivation and pelvic radiation on the development of bladder cancer.
Hafez N, Wang R, Hurwitz M, Ma X, Petrylak D. The impact of androgen deprivation and pelvic radiation on the development of bladder cancer. Journal Of Clinical Oncology 2016, 34: 439-439. DOI: 10.1200/jco.2016.34.2_suppl.439.Peer-Reviewed Original ResearchAndrogen deprivation therapyUrothelial bladder cancerProstate cancer patientsSecondary bladder cancerBladder cancerCancer patientsRadiation therapyAndrogen deprivationProstate cancerRecurrent urothelial bladder cancerElderly prostate cancer patientsCox proportional modelingRetrospective cohort studyKaplan-Meier analysisSEER-Medicare databaseSimilar patient populationsProstate cancer treatmentPrimary prostate cancerDeprivation therapyMedian followPelvic radiationCohort studyMale predilectionProportional modelingPatient population
2015
The effect of BCG intravesical therapy and recurrence on PDL1 expression in non-invasive bladder cancers.
Hurwitz M, Adeniran A, Yao X, Hafez N, Schalper K, Rimm D, Petrylak D. The effect of BCG intravesical therapy and recurrence on PDL1 expression in non-invasive bladder cancers. Journal Of Clinical Oncology 2015, 33: e15504-e15504. DOI: 10.1200/jco.2015.33.15_suppl.e15504.Peer-Reviewed Original Research
2006
Finding the Kool Mixx: how Brown & Williamson used music marketing to sell cigarettes.
Hafez N, Ling PM. Finding the Kool Mixx: how Brown & Williamson used music marketing to sell cigarettes. Tobacco Control 2006, 15: 359-66. PMID: 16998169, PMCID: PMC2563654, DOI: 10.1136/tc.2005.014258.Peer-Reviewed Original Research