2024
Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with high body mass index (BMI).
Aragon-Ching J, Petrylak D, Sridhar S, Gupta S, Grivas P, Powles T, Gurney H, Jacob N, Tyroller K, Guenther S, Bellmunt J. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (aUC): Long-term outcomes from the JAVELIN Bladder 100 trial in patients (pts) with high body mass index (BMI). Journal Of Clinical Oncology 2024, 42: 600-600. DOI: 10.1200/jco.2024.42.4_suppl.600.Peer-Reviewed Original ResearchProgression-free survivalAdvanced urothelial carcinomaPlatinum-based chemotherapyBody mass indexHigher body mass indexLong-term outcomesOverall survivalLong-term safetyStandard of careMedian progression-free survivalProgression-free survival ratesAnalysis of long-term outcomesBSC-alone armMedian follow-upProlonged overall survivalLevel 1 evidenceLong-term efficacyInternational treatment guidelinesPost hoc analysisJAVELIN BladderMedian OSMetastatic UCOS ratesSafety populationData cutoff
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 endpointUpdated outcomes in TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI).
Tagawa S, Balar A, Petrylak D, Rezazadeh A, Loriot Y, Flechon A, Jain R, Agarwal N, Bupathi M, Barthelemy P, Beuzeboc P, Palmbos P, Kyriakopoulos C, Pouessel D, Sternberg C, Tonelli J, Sierecki M, Zhou H, Grivas P. Updated outcomes in TROPHY-U-01 cohort 1, a phase 2 study of sacituzumab govitecan (SG) in patients (pts) with metastatic urothelial cancer (mUC) that progressed after platinum (PT)-based chemotherapy and a checkpoint inhibitor (CPI). Journal Of Clinical Oncology 2023, 41: 526-526. DOI: 10.1200/jco.2023.41.6_suppl.526.Peer-Reviewed Original ResearchMetastatic urothelial cancerTreatment-related adverse eventsObjective response rateProgression-free survivalDuration of responseClinical benefit ratePhase 2 studyCheckpoint inhibitorsSacituzumab govitecanOverall survivalPrior therapyCentral reviewResponse rateAnti-Trop-2 antibodyAccelerated FDA approvalECOG PS 0Last prior therapyTreatment-related deathsKey secondary endpointNew safety signalsFebrile neutropeniaOS ratesData cutoffPrimary endpointRECIST 1.1
2021
Pembrolizumab (pembro) versus investigator’s choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial.
Bellmunt J, Necchi A, De Wit R, Lee J, Fong L, Vogelzang N, Durán M, Petrylak D, Choueiri T, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Xu J, Moreno B, Godwin J, Bajorin D, Vaughn D, Fradet Y. Pembrolizumab (pembro) versus investigator’s choice of paclitaxel, docetaxel, or vinflunine in recurrent, advanced urothelial cancer (UC): 5-year follow-up from the phase 3 KEYNOTE-045 trial. Journal Of Clinical Oncology 2021, 39: 4532-4532. DOI: 10.1200/jco.2021.39.15_suppl.4532.Peer-Reviewed Original ResearchDuration of responseMetastatic urothelial cancerUrothelial cancerKEYNOTE-045Median OSOS benefitInvestigator's choiceKey secondary end pointMedian DOREnd pointAdvanced urothelial cancerECOG PS 0Platinum-containing regimenPrimary end pointSecondary end pointsTreatment-related AEsPhase 3 trialYears of therapyRECIST v1.1Baseline hemoglobinECOG PSMeasurable diseaseOS ratesPrior therapyData cutoff
2020
Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma.
Rosenberg J, Flaig T, Friedlander T, Milowsky M, Srinivas S, Petrylak D, Merchan J, Bilen M, Carret A, Yuan N, Sasse C, Hoimes C. Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Journal Of Clinical Oncology 2020, 38: 5044-5044. DOI: 10.1200/jco.2020.38.15_suppl.5044.Peer-Reviewed Original ResearchMetastatic urothelial carcinomaPD-1/PD-L1 inhibitorsPD-L1 inhibitorsAdverse eventsUrothelial carcinomaDay 1Common treatment-emergent adverse eventsTreatment-emergent adverse eventsCisplatin-ineligible patientsSafety/tolerabilityFirst-line settingManageable safety profilePeripheral sensory neuropathyPlatinum-containing chemotherapyTumor response ratePD-L1 statusMedian DoRMedian OSMedian PFSPFS ratesRECIST v1.1Primary endpointLiver metastasesOS ratesPD-L1
2019
902O An adaptive, biomarker directed platform study in metastatic urothelial cancer (BISCAY) with durvalumab in combination with targeted therapies
Powles T, Balar A, Gravis G, Jones R, Ravaud A, Florence J, Grivas P, Petrylak D, Galsky M, Carles J, Sridhar S, Arkenau H, Carroll D, DeCesare J, Mercier F, Hodgson D, Stone J, Cosaert J, Landers D. 902O An adaptive, biomarker directed platform study in metastatic urothelial cancer (BISCAY) with durvalumab in combination with targeted therapies. Annals Of Oncology 2019, 30: v356-v357. DOI: 10.1093/annonc/mdz249.001.Peer-Reviewed Original ResearchSarah Cannon Research InstituteBristol-Myers SquibbGenentech/RocheUrothelial cancerSeattle GeneticsMonotherapy armArm BClovis OncologyRoche LaboratoriesAstellas PharmaNext-generation sequencingRoche-GenentechAdvanced urothelial cancerConclusions Combination treatmentNon-randomized controlsMetastatic urothelial cancerPD-L1 expressionKey secondary objectivePD-L1 inhibitorsTumor DNA alterationsEli LillyBavarian NordicConfirmed responsesD monotherapyOS rates