2024
Analysis of drug-related interstitial lung disease (ILD) inpatients (pts) treated with datopotamab deruxtecan (Dato-DXd).
Sands J, Lisberg A, Bardia A, Shimizu T, Ahn M, Paz-Ares L, Meric-Bernstam F, Kitazono S, Krop I, Girard N, Pons Tostivint E, Heist R, Cornelissen R, Pistilli B, Lee K, Howarth P, Gu W, Fairhurst R, Khan S, Okamoto I. Analysis of drug-related interstitial lung disease (ILD) inpatients (pts) treated with datopotamab deruxtecan (Dato-DXd). Journal Of Clinical Oncology 2024, 42: 8623-8623. DOI: 10.1200/jco.2024.42.16_suppl.8623.Peer-Reviewed Original ResearchNon-small cell lung cancerInterstitial lung diseaseDrug-related interstitial lung diseaseInterstitial lung disease incidenceBreast cancerTumor typesCases of interstitial lung diseaseCell lung cancerSolid tumor typesDuration of treatmentMultiple tumor typesAntibody drug conjugatesCheckpoint inhibitorsDrug interruptionDose reductionDrug withdrawalSolid tumorsAdverse eventsTumor indicationsLung cancerPooled analysisClinical dataLung diseasePT subgroupAdjudication committeeClinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan
Heist R, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung S, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer Treatment Reviews 2024, 125: 102720. PMID: 38502995, DOI: 10.1016/j.ctrv.2024.102720.Peer-Reviewed Original ResearchNon-small cell lung cancerTriple-negative breast cancerTrophoblast cell surface antigen 2Antibody drug conjugatesAdverse eventsHR+/HER2- BCDelivery of cytotoxic agents to tumor cellsBreast cancerCytotoxic agents to tumor cellsTopoisomerase I inhibitor payloadAgents to tumor cellsInterstitial lung disease/pneumonitisInfusion-related reactionsSolid tumor indicationsPhase I studyCell lung cancerNovel antibody drug conjugatesSystemic therapySafety profileSolid tumorsTumor indicationsTumor cellsLung cancerClinical managementClinical trials
2023
Phase II trial of pembrolizumab in patients with brain metastases.
Brastianos P, Kim A, Giobbie-Hurder A, Lee E, Lin N, Overmoyer B, Wen P, Nayak L, Cohen J, Dietrich J, Heist R, Krop I, Lawrence D, Mayer E, Winer E, Shih H, Oh K, Cahill D, Gerstner E, Sullivan R. Phase II trial of pembrolizumab in patients with brain metastases. Journal Of Clinical Oncology 2023, 41: 2006-2006. DOI: 10.1200/jco.2023.41.16_suppl.2006.Peer-Reviewed Original ResearchBrain metastasesPrimary endpointBenefit rateEvaluable patientsLung cancerBreast cancerTherapeutic strategiesSingle-arm phase 2 clinical trialNon-small cell lung cancerHormone receptor-positive diseaseSmall cell lung cancerPhase 2 clinical trialGrade 4 toxicityLogical therapeutic strategyRECIST 1.1 criteriaMedian overall survivalPD-1 blockadePD-1 inhibitorsPrimary efficacy endpointReceptor-positive diseasePhase II trialImmune-based strategiesTriple-negative subtypeCell lung cancerT cell cytotoxicity
2020
Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors
Tsurutani J, Iwata H, Krop I, Jänne PA, Doi T, Takahashi S, Park H, Redfern C, Tamura K, Wise-Draper TM, Saito K, Sugihara M, Singh J, Jikoh T, Gallant G, Li BT. Targeting HER2 with Trastuzumab Deruxtecan: A Dose-Expansion, Phase I Study in Multiple Advanced Solid Tumors. Cancer Discovery 2020, 10: 688-701. PMID: 32213540, PMCID: PMC8292921, DOI: 10.1158/2159-8290.cd-19-1014.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerMutant non-small cell lung cancerTreatment-emergent adverse eventsMutant solid tumorsObjective response rateProgression-free survivalMedian progression-free survivalT-DXdSolid tumorsTrastuzumab deruxtecanDrug-related treatment-emergent adverse eventsCommon treatment-emergent adverse eventsConfirmed objective response rateSafety/tolerabilityAdvanced solid tumorsBiliary tract cancerPhase I trialHER2-positive breastInterstitial lung diseaseCell lung cancerSalivary gland cancerHeterogeneous patient populationUnmet medical needConfirmed responsesDose expansion
2019
A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer
Abramson VG, Oliveira M, Cervantes A, Wildiers H, Patel MR, Bauer TM, Bedard PL, Becerra C, Richey S, Wei MC, Reyner E, Bond J, Cui N, Wilson TR, Moore HM, Saura C, Krop IE. A phase Ib, open-label, dose-escalation study of the safety and pharmacology of taselisib (GDC-0032) in combination with either docetaxel or paclitaxel in patients with HER2-negative, locally advanced, or metastatic breast cancer. Breast Cancer Research And Treatment 2019, 178: 121-133. PMID: 31368034, DOI: 10.1007/s10549-019-05360-3.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarcinoma, Non-Small-Cell LungClass I Phosphatidylinositol 3-KinasesDocetaxelFemaleHumansImidazolesLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedMutationNeoplasm MetastasisOxazepinesPaclitaxelReceptor, ErbB-2Survival AnalysisTreatment OutcomeConceptsNon-small cell lung cancerDose-limiting toxicityMetastatic breast cancerAdverse eventsBreast cancerPhase IbClinical benefit rateDose-expansion studyObjective response ratePhase II doseSerious adverse eventsDose-escalation studyCell lung cancerBenefit-risk profileDays on/2ResultsEighty patientsPrimary endpointSecondary endpointsSafety profileLung cancerBenefit ratePatientsSingle agentResponse rateDocetaxel
2018
OA02.07 Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung Cancer
Tsurutani J, Park H, Doi T, Modi S, Takahashi S, Nakagawa K, Krop I, Waqar S, Yoh K, Li B, Taira S, Jikoh T, Singh J, Sugihara M, Jänne P. OA02.07 Updated Results of Phase 1 Study of DS-8201a in HER2-Expressing or –Mutated Advanced Non-Small-Cell Lung Cancer. Journal Of Thoracic Oncology 2018, 13: s324. DOI: 10.1016/j.jtho.2018.08.244.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerPhase 1 studyDS-8201aLung cancerUpdated Results