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
2020
IMvigor010: Primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC).
Hussain M, Powles T, Albers P, Castellano D, Daneshmand S, Gschwend J, Nishiyama H, Oudard S, Tayama D, Davarpanah N, Degaonkar V, Shi Y, Mariathasan S, Grivas P, O'Donnell P, Rosenberg J, Geynisman D, Hoffman-Censits J, Petrylak D, Bellmunt J. IMvigor010: Primary analysis from a phase III randomized study of adjuvant atezolizumab (atezo) versus observation (obs) in high-risk muscle-invasive urothelial carcinoma (MIUC). Journal Of Clinical Oncology 2020, 38: 5000-5000. DOI: 10.1200/jco.2020.38.15_suppl.5000.Peer-Reviewed Original ResearchMuscle-invasive urothelial carcinomaDisease-free survivalNeoadjuvant chemoAdjuvant chemoPrimary endpointPrimary analysisECOG PS 0Interim overall survivalLymph node dissectionPD-L1 testingLevel 1 evidenceITT populationObs armPostsurgical radiationCheckpoint inhibitorsGastrointestinal toxicityMainstay treatmentNode dissectionPrimary resectionAdjuvant studiesOverall survivalPS 0Radical surgeryClinical factorsPrimary disease