2024
Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H.
O'Donnell P, Hoimes C, Rosenberg J, Petrylak D, Mar N, Barata P, Srinivas S, Gourdin T, Henry E, Bilen M, George S, Rao S, Assikis V, Burgess E, Lewis B, Bowman I, Brancato S, Mildiner-Earley S, Zhu Y, Flaig T. Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle invasive bladder cancer (MIBC)—2-year event-free survival and safety data for Cohort H. Journal Of Clinical Oncology 2024, 42: 4564-4564. DOI: 10.1200/jco.2024.42.16_suppl.4564.Peer-Reviewed Original ResearchPathological complete responsePathologic complete response ratePathological downstaging ratePathological downstagingEnfortumab vedotinEV treatmentUrothelial cancerPelvic lymph node dissectionAntitumor activityCisplatin-ineligible patientsNeoadjuvant treatment optionsPhase 1b/2 studyCentral pathology reviewMetastatic urothelial cancerLymph node dissectionEvent-free survivalCancer-related therapyAntibody-drug conjugatesStage cT2Improved OSComplete responseECOG PSNeoadjuvant treatmentCisplatin-ineligibleNode dissection
2023
Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H.
Flaig T, Rosenberg J, Hoimes C, O'Donnell P, Mar N, Gourdin T, Henry S, Bilen M, George S, Barata P, Srinivas S, Rao S, Assikis V, Burgess E, Ramamurthy C, Haas G, Lukas J, Mildiner-Earley S, Yu Y, Petrylak D. Study EV-103: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients (pts) with muscle invasive bladder cancer (MIBC): Updated results for Cohort H. Journal Of Clinical Oncology 2023, 41: 4595-4595. DOI: 10.1200/jco.2023.41.16_suppl.4595.Peer-Reviewed Original ResearchMuscle-invasive bladder cancerEvent-free survivalPhase 1b/2 studyPathological complete responseCancer-related therapyEV treatmentUrothelial cancerSafety profilePD-1/L1 inhibitorsMedian event-free survivalPelvic lymph node dissectionAdvanced urothelial cancerAntitumor activityCisplatin-ineligible patientsManageable safety profileNeoadjuvant treatment optionsOngoing phase 2Pathological downstaging ratePts underwent surgeryTolerable safety profileCentral pathology reviewKey secondary endpointLymph node dissectionPhase 3 studyInvasive bladder cancer