TROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy.
Tagawa S, Petrylak D, Grivas P, Agarwal N, Sternberg C, Hernandez C, Siemon-Hryczyk P, Goswami T, Loriot Y. TROPHY-U-01: A phase II open-label study of sacituzumab govitecan (IMMU-132) in patients with advanced urothelial cancer after progression on platinum-based chemotherapy and/or anti-PD-1/PD-L1 checkpoint inhibitor therapy. Journal Of Clinical Oncology 2019, 37: tps3153-tps3153. DOI: 10.1200/jco.2019.37.15_suppl.tps3153.Peer-Reviewed Original ResearchObjective response rateAdvanced urothelial cancerProgression-free survivalCheckpoint inhibitor therapyPhase 2 trialSacituzumab govitecanUrothelial cancerEvaluable ptsAdverse eventsInhibitor therapyEastern Cooperative Oncology Group performance status scorePhase II open-label studyTrop-2Median progression-free survivalNeutropenia/neutrophil countEpithelial cell surface antigenOpen-label studyPerformance status scorePhase 1/2 trialPlatinum-based chemotherapyActive metabolite SN38Cell surface antigensFebrile neutropeniaMeasurable diseasePivotal cohortSacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study.
Tagawa S, Faltas B, Lam E, Saylor P, Bardia A, Hajdenberg J, Morgans A, Lim E, Kalinsky K, Simpson P, Galsky M, Goswam T, Wegener W, Petrylak D. Sacituzumab govitecan (IMMU-132) in patients with previously treated metastatic urothelial cancer (mUC): Results from a phase I/II study. Journal Of Clinical Oncology 2019, 37: 354-354. DOI: 10.1200/jco.2019.37.7_suppl.354.Peer-Reviewed Original ResearchMetastatic urothelial cancerObjective response rateProgression-free survivalDuration of responseSacituzumab govitecanOverall survivalPhase I/II studyImmune checkpoint inhibitor therapyMedian DORMedian progression-free survivalNeutropenia/neutrophil countNovel antibody-drug conjugateClinical benefit rateEpithelial cell surface antigenPrior treatment linesCheckpoint inhibitor therapyAdvanced solid tumorsCT/MRI scansPhase 2 trialLimited treatment optionsCell surface antigensAntibody-drug conjugatesAdvanced UCFebrile neutropeniaRECIST 1.1