2020
Infigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings.
Lyou Y, Grivas P, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris III H, Rearden J, Andresen C, Wang H, Daneshmand S, Bajorin D, Pal S. Infigratinib and treatment response in advanced/unresectable or metastatic urothelial carcinoma in first-line and later-line treatment settings. Journal Of Clinical Oncology 2020, 38: 5038-5038. DOI: 10.1200/jco.2020.38.15_suppl.5038.Peer-Reviewed Original ResearchUpper tract urothelial carcinomaMetastatic urothelial carcinomaTyrosine kinase inhibitorsPlatinum-based chemotherapyUrothelial bladder carcinomaUrothelial carcinomaTreatment responsePrior platinum-based chemotherapyDisease control rateObjective response rateMutations/fusionsConsistent treatment responseEligible patientsResected diseaseSalvage therapyPrimary endpointPrior linesFGFR3 alterationsLine treatmentControl rateBladder carcinomaSubgroup analysisOutcome measuresPatientsTreatment settingsRelationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in FGFR3 -altered advanced/metastatic urothelial carcinoma (aUC).
Lyou Y, Grivas P, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris H, Rearden J, Ye Y, Wang H, Moran S, Daneshmand S, Bajorin D, Pal S. Relationship between hyperphosphatemia with infigratinib (BGJ398) and efficacy in FGFR3 -altered advanced/metastatic urothelial carcinoma (aUC). Journal Of Clinical Oncology 2020, 38: 576-576. DOI: 10.1200/jco.2020.38.6_suppl.576.Peer-Reviewed Original ResearchDisease control rateOverall response rateTreatment lengthFGFR inhibitorsPrior platinum-based chemotherapyClass effectMedian treatment lengthRECIST 1.0 criteriaCommon adverse eventsMetastatic urothelial carcinomaSignificant clinical activityPlatinum-based chemotherapyPhosphate binder sevelamerMutations/fusionsEligible patientsEfficacy outcomesUnacceptable toxicityAdverse eventsFGFR3 alterationsEfficacy findingsUrothelial carcinomaControl ratePharmacodynamic biomarkersDisease progressionClinical activityFORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression.
Quinn D, Petrylak D, Bellmunt J, Necchi A, Gurney H, Lee J, Van Der Heijden M, Rosenbaum E, Penel N, Pang S, Li J, Garcia del Muro X, Joly F, Papai Z, Ellinghaus P, Lu C, Nakajima K, Ishida T, Nishiyama H, Sternberg C. FORT-1: Phase II/III study of rogaratinib versus chemotherapy (CT) in patients (pts) with locally advanced or metastatic urothelial carcinoma (UC) selected based on FGFR1/3 mRNA expression. Journal Of Clinical Oncology 2020, 38: 489-489. DOI: 10.1200/jco.2020.38.6_suppl.489.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaUrothelial carcinomaPhase II/III studyMedian progression-free survivalTreatment-emergent adverse eventsMuscle-invasive urothelial carcinomaPhase II/IIIDisease control rateOpen-label studyProgression-free survivalStage IV diseaseAcceptable safety profileUrinary tract infectionDNA alterationsStage IIIBIII studyPrior immunotherapyStandard chemotherapyTract infectionsAdverse eventsMedian agePlatinum chemotherapySafety profileControl rateSubgroup analysis
2019
EV-103: Enfortumab vedotin plus pembrolizumab and/or chemotherapy for locally advanced or metastatic urothelial cancer.
Hoimes C, Rosenberg J, Petrylak D, Carret A, Melhem-Bertrandt A, Flaig T. EV-103: Enfortumab vedotin plus pembrolizumab and/or chemotherapy for locally advanced or metastatic urothelial cancer. Journal Of Clinical Oncology 2019, 37: tps4593-tps4593. DOI: 10.1200/jco.2019.37.15_suppl.tps4593.Peer-Reviewed Original ResearchMetastatic urothelial cancerCheckpoint inhibitorsDay 1Urothelial cancerCombination therapyMicrotubule-disrupting agent monomethyl auristatin EInvestigational antibody-drug conjugateFirst-line cisplatinPlatinum-containing regimenDisease control rateImmune checkpoint inhibitorsPhase 1b trialPhase 1 studyDuration of responseEnhanced immune responseMonomethyl auristatin EAntibody-drug conjugatesDose expansionResponse durabilityControl rateDisease progressionImmune responseAuristatin EResponse rateNectin-4Infigratinib in upper tract urothelial carcinoma vs urothelial carcinoma of the bladder and association with comprehensive genomic profiling/cell-free DNA results.
Dizman N, Rosenberg J, Hoffman-Censits J, Quinn D, Petrylak D, Galsky M, Vaishampayan U, De Giorgi U, Gupta S, Burris H, Soifer H, Li G, Dambkowski C, Moran S, Ye Y, Daneshmand S, Bajorin D, Pal S. Infigratinib in upper tract urothelial carcinoma vs urothelial carcinoma of the bladder and association with comprehensive genomic profiling/cell-free DNA results. Journal Of Clinical Oncology 2019, 37: 4510-4510. DOI: 10.1200/jco.2019.37.15_suppl.4510.Peer-Reviewed Original ResearchUpper tract UCMetastatic urothelial carcinomaUrothelial carcinomaPrior platinum-based chemotherapyUpper tract urothelial carcinomaDisease control ratePrior antineoplastic therapyPlatinum-based chemotherapyOverall response rateComprehensive genomic profilingDistinct biologic characteristicsFGFR3-TACC3 fusionMutations/fusionsCell-free DNA resultsGood responseEligible ptsS249C mutationAdjuvant studiesFGFR3 alterationsControl rateAntineoplastic therapyDistinct biologyBiologic characteristicsResponse rateInfigratinib