2023
Primary analysis of TROPHY-U-01 cohort 3, a phase 2 study of sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based therapy.
Grivas P, Pouessel D, Park C, Barthelemy P, Bupathi M, Petrylak D, Agarwal N, Gupta S, Flechon A, Ramamurthy C, Davis N, Recio-Boiles A, Sternberg C, Bhatia A, Pichardo C, Sierecki M, Tonelli J, Zhou H, Tagawa S, Loriot Y. Primary analysis of TROPHY-U-01 cohort 3, a phase 2 study of sacituzumab govitecan (SG) in combination with pembrolizumab (Pembro) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based therapy. Journal Of Clinical Oncology 2023, 41: 518-518. DOI: 10.1200/jco.2023.41.6_suppl.518.Peer-Reviewed Original ResearchTreatment-related adverse eventsObjective response rateMetastatic urothelial cancerProgression-free survivalDuration of responseHigher objective response rateSacituzumab govitecanCentral reviewCohort 3Primary analysisAnti-Trop-2 antibodyMedian DORMedian progression-free survivalAccelerated FDA approvalClinical benefit rateECOG PS 0ECOG PS 1Manageable safety profileTreatment-related deathsNew safety signalsPhase 2 studyG-CSF useAnti-cancer therapyMedian OSSystemic steroids
2018
Docetaxel with or without ramucirumab after immune checkpoint inhibition in platinum-refractory metastatic urothelial carcinoma (mUC): Prespecified subgroup analysis from the phase 3 RANGE trial.
Drakaki A, Kirby C, Van Der Heijden M, Petrylak D, Powles T, Chi K, Flechon A, Necchi A, Geczi L, Lee J, Gakis G, Bracarda S, Chowdhury S, Lin C, Keizman D, Vaishampayan U, Liepa A, Zimmermann A, Bell-McGuinn K, Castellano D. Docetaxel with or without ramucirumab after immune checkpoint inhibition in platinum-refractory metastatic urothelial carcinoma (mUC): Prespecified subgroup analysis from the phase 3 RANGE trial. Journal Of Clinical Oncology 2018, 36: 434-434. DOI: 10.1200/jco.2018.36.6_suppl.434.Peer-Reviewed Original ResearchPlatinum-refractory metastatic urothelial carcinomaImmune checkpoint inhibitorsMetastatic urothelial carcinomaObjective response ratePrior immune checkpoint inhibitorsLiver metastasesPD-L1Subgroup analysisDouble-blinded phase 3 trialPD-1/PD-L1Disease sitesHigher objective response ratePre-specified subgroup analysisInvestigator-assessed PFSImmune checkpoint inhibitionProgression-free survivalPhase 3 trialPrespecified subgroup analysisPlatinum-based chemotherapyFrequency of gradeICI therapyMedian PFSSecondary endpointsCheckpoint inhibitorsData cutoff