921P - Quality of life of metastatic urothelial cancer (mUC) patients treated with enfortumab vedotin (EV) following platinum-containing chemotherapy and a checkpoint inhibitor (CPI): Data from EV-201 cohort 1

EV-201 (NCT03219333) is a single-arm, 2-cohort study of EV in mUC patients treated with prior CPI and platinum-containing chemotherapy (Cohort 1) or a CPI and no prior chemotherapy and are cisplatin-ineligible (Cohort 2). The confirmed ORR rate was 44%. Patient-reported outcome (PRO) measures were included in EV-201 as exploratory endpoints. Our objective was to explore the impact of EV on QoL in Cohort 1 of EV-201. Two validated instruments were included (EORTC QLQ-C30 v3 and EQ-5D-3L). The 30-item EORTC QLQ-C30 measures functioning, symptoms, and financial impact with scores ranging from 0 to 100. The 5-item EQ-5D measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses are converted to a score ranging from 0 to 1, with 0 representing death and 1 representing perfect health. The EQ-5D also records self-rated health status on a 0-100 visual analogue scale (VAS). Assessments were completed at baseline and start of each cycle.Table921P Patient reported outcomes at baseline, cycle 5, and cycle 10TableEuropean Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Mean (SD) ScoresBaseline n=120Cycle 5 n=59Cycle 10 n=12Global quality of life63.0 (20.8)65.4 (19.8)69.4 (25.0)Functional domainsPhysical functioning76.4 (20.8)78.9 (16.7)92.2 (8.4)Role functioning73.3 (27.8)74.3 (23.2)84.7 (11.1)Emotional functioning81.7 (18.4)85.3 (17.7)86.8 (11.5)Cognitive functioning85.3 (19.2)83.9 (18.8)93.1 (13.2)Social functioning73.5 (26.1)76.3 (25.7)86.1 (21.1)Symptom scalesFatigue35.3 (22.9)36.4† (21.1)17.6† (12.9)Nausea and vomiting9.0 (15.9)5.5† (13.0)1.4† (4.8)Dyspnoea16.9 (23.4)17.5† (27.5)13.9† (17.2)Insomnia27.2 (28.7)22.4† (22.8)11.1† (16.4)Appetite loss24.7 (30.1)23.6† (25.8)11.1† (25.9)Constipation24.4 (30.5)13.2† (20.7)8.3† (15.1)Diarrhea8.9 (18.2)6.8† (16.1)5.6† (13.0)Pain29.9 (28.7)22.3† (26.6)4.2† (7.5)Financial difficulties18.2 (30.0)19.2† (27.8)27.8† (27.8)EuroQol 5 dimension 3 level Questionnaire (EQ-5D-3L) Mean (SD) scoresVisual analogue scale (VAS)66.9 (20.5)67.1 (20.8)78.4 (27.3)Utility score0.795 (0.163)0.809 (0.148)0.910 (0.102)†Higher scores represent a positive effect except for symptom domains as marked with †, where higher scores represent greater symptom burden. SD – standard deviation. Of 125 subjects from Cohort 1, 120 (96%) received EV and completed both instruments at baseline. Across all cycles, >86% of subjects with available data at each cycle complete