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

Abstract

Background: 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. Methods: 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. [Table presented] Results: 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 completed both instruments. QLQ-C30 domain scores, inclusive of general QoL, functioning, and symptom scores, remained stable over time. Some domains demonstrated trends toward improvement across the study period (e.g. emotional, role, and social functioning, as well as pain, fatigue, appetite loss, constipation, and diarrhea) (Table). EQ-5D utility and VAS scores also remained stable throughout the treatment period. Variability and small sample size limit definitive conclusions. Conclusions: Findings demonstrate that QoL is either maintained or improved for patients on treatment with EV, which complement the efficacy and safety results from EV-201 Cohort 1. Clinical trial identification: NCT03219333. Editorial acknowledgement: Lisa Bloudek of Curta, funded by Seattle Genetics. Shang-Ying Liang of Seattle Genetics provided statistical support and QC of results. Legal entity responsible for the study: Seattle Genetics Inc. Funding: Seattle Genetics, Inc. and Astellas Pharma, Inc. Disclosure: B.A. McGregor: Advisory / Consultancy: Astellas Pharma Inc.; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Bayer; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy: Decibel Therapeutics; Advisory / Consultancy, Research g…