2023
Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data.
Friedlander T, Milowsky M, O'Donnell P, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, McKay R, Bilen M, Borchiellini D, Iafolla M, Carret A, Yu Y, Guseva M, Kataria R, Rosenberg J. Enfortumab vedotin (EV) with or without pembrolizumab (P) in patients (pts) who are cisplatin-ineligible with previously untreated locally advanced or metastatic urothelial cancer (la/mUC): Additional 3-month follow-up on cohort K data. Journal Of Clinical Oncology 2023, 41: 4568-4568. DOI: 10.1200/jco.2023.41.16_suppl.4568.Peer-Reviewed Original ResearchProgression-free survivalDisease control rateDuration of responseMedian DORMedian progression-free survivalBlinded independent central reviewOverall survivalPFS rateAdverse eventsOS ratesSkin reactionsTreatment-emergent adverse eventsTreatment-related adverse eventsFirst-line treatment optionManageable safety profileObjective response ratePD-1 inhibitorsMetastatic urothelial cancerSevere skin reactionsIndependent central reviewNew safety concernsHigh unmet needImmunogenic cell deathRECIST v1.1Primary endpoint
2021
Study EV-103: Update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC).
Friedlander T, Milowsky M, Bilen M, Srinivas S, McKay R, Flaig T, Hoimes C, Balar A, Henry E, Petrylak D, Sasse C, Kataria R, Yu Y, Carret A, Rosenberg J. Study EV-103: Update on durability results and long term outcome of enfortumab vedotin + pembrolizumab in first line locally advanced or metastatic urothelial carcinoma (la/mUC). Journal Of Clinical Oncology 2021, 39: 4528-4528. DOI: 10.1200/jco.2021.39.15_suppl.4528.Peer-Reviewed Original ResearchMicrotubule-disrupting agent monomethyl auristatin EObjective response rateMetastatic urothelial carcinomaAntibody-drug conjugatesUrothelial carcinomaCommon treatment-related adverse eventsPD-1/PD-L1 inhibitorsConfirmed objective response rateModest objective response rateTreatment-related adverse eventsCarboplatin-based regimensSafety/tolerabilityFirst-line settingOverall survival benefitPeripheral sensory neuropathyNew safety signalsPD-L1 inhibitorsLong-term outcomesImmunogenic cell deathGreater antitumor activityMonomethyl auristatin EBreakthrough therapy designationMedian DoRMedian OSMedian PFS