895TiP A phase I study of AMG 160, a half-life extended bispecific T cell engager (HLE BiTE) immuno-oncology therapy targeting PSMA, in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Tran B, Kouros-Mehr H, Fermin A, Horvath L, Roncolato F, Rettig M, Dorff T, Tagawa S, Subudhi S, Antonarakis E, Armstrong A, Petrylak D, Fizazi K, Salvati M, Scher H. 895TiP A phase I study of AMG 160, a half-life extended bispecific T cell engager (HLE BiTE) immuno-oncology therapy targeting PSMA, in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v353. DOI: 10.1093/annonc/mdz248.052.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerProstate-specific membrane antigenBristol-Myers SquibbPreliminary antitumor activityImmuno-oncology therapiesProstate cancerAntitumor activitySanofi-AventisCentral nervous system metastasesCastration-resistant prostate cancerBoehringer IngelheimContinuous androgen deprivation therapyEli LillySeattle GeneticsActive autoimmune diseaseGenentech/RochePFS/OSPhase 2 doseRECIST 1.1 criteriaTaxane-based regimensAndrogen deprivation therapyNervous system metastasesT effector cellsPhase 1 studyDuration of response901O EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma
Hoimes C, Rosenberg J, Srinivas S, Petrylak D, Milowsky M, Merchan J, Bilen M, Gupta S, Carret A, Yuan N, Melhem-Bertrandt A, Flaig T. 901O EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Annals Of Oncology 2019, 30: v356. DOI: 10.1093/annonc/mdz249.Peer-Reviewed Original ResearchBristol-Myers SquibbMetastatic urothelial carcinomaAdverse eventsSeattle GeneticsUrothelial carcinomaDay 1Common treatment-emergent adverse eventsEli LillyTreatment-emergent adverse eventsDose-escalation cohortsGenentech/RocheImmune-mediated eventsPhase 1b studyPost-baseline scanSafety/tolerabilityManageable safety profileSystemic steroid treatmentKey secondary objectiveStandard of careBavarian NordicFortress BiotechMonotherapy dataRECIST 1.1Encouraging efficacyPrimary endpoint902O 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 rates929P Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase III study
van der Heijden M, Powles T, Petrylak D, de Wit R, Chi K, Necchi A, Sternberg C, Matsubara N, Nishiyama H, Castellano D, Hussain S, Bamias A, Hozak R, Rhodes R, Xia M, Rasmussen E, Aggarwal A, Wijayawardana S, Bell-McGuinn K, Drakaki A. 929P Biomarker analyses of ramucirumab in patients with platinum refractory urothelial cancer from RANGE, a global, randomized, double-blind, phase III study. Annals Of Oncology 2019, 30: v373-v374. DOI: 10.1093/annonc/mdz249.028.Peer-Reviewed Original ResearchCombined positive scorePD-L1 statusPersonal feesHazard ratioBasal subtypeMolecular subtypesEli LillyPD-L1 combined positive scorePlatinum-refractory urothelial carcinomaPositive PD-L1 statusTumor cellsSeattle GeneticsExploratory biomarker analysisImmune cell stainingPD-L1 groupRefractory urothelial cancerImproved overall survivalPD-L1 antibodiesPD-L1 immunohistochemistryClaudin-low subtypeRefractory urothelial carcinomaUrothelial carcinoma molecular subtypesArchival tumor tissueBiomarker analysisMedian OS