2388 - 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

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.

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.Table:

921P Patient reported outcomes at baseline, cycle 5, and cycle 10

Higher scores represent a positive effect except for symptom domains as marked with ^†, where higher scores represent greater symptom burden. SD – standard deviation.

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 grant / Funding (self), Research grant / Funding (institution): Exelixis; Advisory / Consultancy: Genentech; Advisory / Consultancy: Janssen; Advisory / Consultancy: Nextar; Advisory / Consultancy: Pfizer; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Seattle Genetics; Advisory / Consultancy: AstraZeneca; Research grant / Funding (self), Research grant / Funding (institution): Calithera Biosciences. P.H. O’Donnell: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Merck; Honoraria (self), Honoraria (institution), Research grant / Funding (self), Research grant / Funding (institution): Seattle Genetics; Shareholder / Stockholder / Stock options: Allergan; Shareholder / Stockholder / Stock options: PrescriptIQ; Honoraria (self), Honoraria (institution): Astellas Pharma Inc.; Honoraria (self), Honoraria (institution): AstraZeneca; Honoraria (self), Honoraria (institution), Research grant / Funding (self), Research grant / Funding (institution): Genentech; Honoraria (self), Honoraria (institution): Harrison Consulting Group; Honoraria (self), Honoraria (institution): Inovio; Honoraria (self), Honoraria (institution), Research grant / Funding (self), Research grant / Funding (institution), Non-remunerated activity/ies, Other Relationship: Janssen; Honoraria (self), Honoraria (institution): Kantar Health; Research grant / Funding (self), Research grant / Funding (institution): Bristol-Myers Squibb; Honoraria (self), Honoraria (institution): OncLive; Honoraria (self), Honoraria (institution): Parexel; Honoraria (self), Honoraria (institution): Quintiles; Research grant / Funding (self), Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (self), Research grant / Funding (institution): Acerta; Non-remunerated activity/ies, Other Relationship: Advance Medical; Licensing / Royalties: Named as co-inventor on pending patent for a genomic prescribing system for medication prescribing. A. Balar: Advisory / Consultancy: Astellas Pharma Inc.; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy: Cerulean Pharma; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Genentech; Advisory / Consultancy: Incyte; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Merck; Advisory / Consultancy: Pfizer; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Seattle Genetics. D.P. Petrylak: Advisory / Consultancy: Astellas Pharma Inc.; Research grant / Funding (self), Research grant / Funding (institution): Astellas Medivation; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Bayer; Advisory / Consultancy: Bellicum Pharma; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Dendreon; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Ferring; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Johnson&Johnson; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Seattle Genetics; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Millennium; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): MedImmune; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Pfizer; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Roche; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self), Research grant / Funding (institution): Sanofi; Advisory / Consultancy: Tyme; Research grant / Funding (self), Research grant / Funding (institution): Agensys; Research grant / Funding (self), Research grant / Funding (institution): Clovis Onc; Research grant / Funding (self), Research grant / Funding (institution): Endocyte; Speaker Bureau / Expert testimony: Celgene; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Lilly; Advisory / Consultancy: Medivation; Research grant / Funding (self), Research grant / Funding (institution): Genentech; Research grant / Funding (self), Research grant / Funding (institution): Innocrin Pharma; Research grant / Funding (self), Research grant / Funding (institution): Merck; Research grant / Funding (self), Research grant / Funding (institution): Novartis; Research grant / Funding (self), Research grant / Funding (institution): Progenics; Research grant / Funding (self), Research grant / Funding (institution): Sotio. J.E. Rosenberg: Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution): Agensys; Honoraria (self), Honoraria (institution): AstraZeneca; Advisory / Consultancy: AstraZeneca/MedImmune; Advisory / Consultancy: Bayer; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Inovo Pharmaceuticals; Advisory / Consultancy: Lilly; Advisory / Consultancy, Shareholder / Stockholder / Stock options: Merck; Advisory / Consultancy, Research grant / Funding (self), Research grant / Funding (institution), Travel / Accommodation / Expenses: Genentech/Roche; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Seattle Genetics; Shareholder / Stockholder / Stock options: Illumina; Honoraria (self), Honoraria (institution): Medcape; Honoraria (self), Honoraria (institution): Peerview; Honoraria (self), Honoraria (institution): UpToDate; Honoraria (self), Honoraria (institution): Vindico; Licensing / Royalties: Predictor of Platinum sensitivity; Research grant / Funding (self), Research grant / Funding (institution): Incyte; Research grant / Funding (self), Research grant / Funding (institution): Mirati Therapeutics; Research grant / Funding (self), Research grant / Funding (institution): Novartis; Research grant / Funding (self), Research grant / Funding (institution): Oncogenex; Research grant / Funding (self), Research grant / Funding (institution): Viralytics. E. Yu: Advisory / Consultancy: Amgen; Advisory / Consultancy: AstraZeneca; Research grant / Funding (institution): Astellas; Advisory / Consultancy, Research grant / Funding (institution): Bayer; Advisory / Consultancy: Churchill Pharma; Advisory / Consultancy, Research grant / Funding (institution): Dendreon; Advisory / Consultancy: EMD Serono; Advisory / Consultancy: Incyte; Research grant / Funding (institution): Genentech/Roche; Advisory / Consultancy: Janssen; Advisory / Consultancy, Research grant / Funding (institution): Merck; Advisory / Consultancy: QED Therapeutics; Advisory / Consultancy, Research grant / Funding (institution): Seattle Genetics; Advisory / Consultancy: Tolmar; Advisory / Consultancy: Pharmacyclics; Research grant / Funding (institution): Agensys; Research grant / Funding (self): Daiichi Sankyo. D.I. Quinn: Full / Part-time employment: University of Southern California; Research grant / Funding (institution): Seattle Genetics; Advisory / Consultancy, Research grant / Funding (institution): Novartis; Advisory / Consultancy: Astellas; Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Advisory / Consultancy: Bayer; Advisory / Consultancy, Travel / Accommodation / Expenses: Bristol-Myers Squibb; Advisory / Consultancy: Dendreon; Advisory / Consultancy: Exelixis; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Janssen; Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy: Sanofi. S.N. Shah: Full / Part-time employment: Astellas Pharma Inc. J. Pinelli: Shareholder / Stockholder / Stock options, Full / Part-time employment: Seattle Genetics. Z. Hepp: Shareholder / Stockholder / Stock options, Full / Part-time employment: Seattle Genetics. M. Galsky: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myers Squibb; Advisory / Consultancy: Genentech; Advisory / Consultancy: Merck; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Dracen; Advisory / Consultancy: Dragonfly Therapeutics; Advisory / Consultancy: Astellas; Advisory / Consultancy: Seattle Genetics; Advisory / Consultancy: Janssen; Research grant / Funding (institution): Dendreon; Research grant / Funding (institution): Roche/Genentech.