Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer
O'Donnell P, Milowsky M, Petrylak D, Hoimes C, Flaig T, Mar N, Moon H, Friedlander T, McKay R, Bilen M, Srinivas S, Burgess E, Ramamurthy C, George S, Geynisman D, Bracarda S, Borchiellini D, Geoffrois L, Rey J, Ferrario C, Carret A, Yu Y, Guseva M, Moreno B, Rosenberg J. Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer. Journal Of Clinical Oncology 2023, 41: 4107-4117. PMID: 37369081, PMCID: PMC10852367, DOI: 10.1200/jco.22.02887.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCisplatin-ineligible patientsDuration of responseMetastatic urothelial cancerUrothelial cancerAdverse eventsHigher treatment-related adverse eventsPhase Ib/II studyMedian DORFirst-line treatment optionEnd pointBlinded independent central reviewCommon grade 3Objective response ratePrimary end pointSecondary end pointsNew safety signalsCisplatin-based therapyIndependent central reviewUntreated LACombination armDurable responsesII studyMaculopapular rashSurvival benefitEnfortumab 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