2022
FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression
Sternberg CN, Petrylak DP, Bellmunt J, Nishiyama H, Necchi A, Gurney H, Lee JL, van der Heijden MS, Rosenbaum E, Penel N, Pang ST, Li JR, del Muro X, Joly F, Pápai Z, Bao W, Ellinghaus P, Lu C, Sierecki M, Coppieters S, Nakajima K, Ishida TC, Quinn DI. FORT-1: Phase II/III Study of Rogaratinib Versus Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma Selected Based on FGFR1/3 mRNA Expression. Journal Of Clinical Oncology 2022, 41: 629-639. PMID: 36240478, PMCID: PMC9870218, DOI: 10.1200/jco.21.02303.Peer-Reviewed Original ResearchConceptsMetastatic urothelial carcinomaUrothelial carcinomaOverall survivalComparable efficacyPan-fibroblast growth factor receptor inhibitorPhase II/III studyPrior platinum-containing regimenPhase II/IIIMRNA overexpressionGrowth factor receptor inhibitorsFGFR-directed therapiesGrade 3/4 eventsMedian overall survivalPlatinum-containing regimenPrimary end pointAdvanced urothelial carcinomaOpen-label trialDNA alterationsVersus ChemotherapyIII studyManageable safetyPlatinum chemotherapyResponse rate analysisReceptor inhibitorsInterim analysis
2020
Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.
Rosenberg J, Flaig T, Friedlander T, Milowsky M, Srinivas S, Petrylak D, Merchan J, Bilen M, Carret A, Yuan N, Sasse C, Hoimes C. Study EV-103: Preliminary durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2020, 38: 441-441. DOI: 10.1200/jco.2020.38.6_suppl.441.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaAdverse eventsUrothelial carcinomaDay 1Common treatment-emergent adverse eventsPD-1/PD-L1 inhibitorsTreatment-emergent adverse eventsSafety/tolerabilityFirst-line settingManageable safety profilePeripheral sensory neuropathyPD-L1 statusPD-L1 inhibitorsMedian DoRMedian PFSRECIST v1.1Primary endpointLiver metastasesStandard therapyPD-L1Sensory neuropathySafety profilePlatinum chemotherapyHigh patientMulticohort studyFORT-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
Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC).
Rosenberg J, Sridhar S, Zhang J, Smith D, Ruether J, Flaig T, Baranda J, Lang J, Plimack E, Sangha R, Heath E, Merchan J, Quinn D, Srinivas S, Milowsky M, Wu C, Gartner E, Melhem-Bertrandt A, Petrylak D. Mature results from EV-101: A phase I study of enfortumab vedotin in patients with metastatic urothelial cancer (mUC). Journal Of Clinical Oncology 2019, 37: 377-377. DOI: 10.1200/jco.2019.37.7_suppl.377.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related AEsLiver metastasesMedian followUrothelial cancerPrimary tumor siteUnmet medical needMedian PFSPrior chemotherapyMonotherapy studiesMedian durationPoor prognosisCombination therapyPlatinum chemotherapyMature resultsDay 1Nectin-4Medical needTumor siteSecondary objectivePhase IAntitumor activityEncouraging responseSurvival dataChemotherapy